title: Commission Implementing Regulation (EU) 2019/386 of 11 March 2019 laying down rules with regard to the apportionment of tariff rate quotas for certain agricultural products included in the WTO schedule of the Union following the withdrawal of the United Kingdom from the Union and with regard to import licences issued and import rights allocated under those tariff rate quotas

text:
                  12.3.2019

                  EN

                  Official Journal of the European Union

                  L 70/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/386
         of 11 March 2019
         laying down rules with regard to the apportionment of tariff rate quotas for certain agricultural products included in the WTO schedule of the Union following the withdrawal of the United Kingdom from the Union and with regard to import licences issued and import rights allocated under those tariff rate quotas
         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 points (a) and (c) of Article 187 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2019/216 of the European Parliament and of the Council (2) provides that the tariff rate quotas included in the Union's schedule of concessions and commitments annexed to the General Agreement on Tariffs and Trade 1994 are to be apportioned between the Union and the United Kingdom based on the EU-27 share in the quota usage set out in the Annex to that Regulation.

                     (2)

                     As a result, measures need to be adopted in order to implement the apportionment of the relevant tariff rate quotas for certain agricultural products set out in Part A of the Annex to Regulation (EU) 2019/216. In particular, it should be established that the tariff rate quota quantities set out in the Regulations opening the respective tariff rate quotas are replaced by the new quantities resulting from the apportionment implemented by this Regulation.

                     (3)

                     Within certain tariff rate quotas included in the Union's schedule of concessions and commitments annexed to the General Agreement on Tariffs and Trade 1994 quantities have been allocated to particular third countries as part of the Union's international commitments. It is therefore necessary to apportion those specifically allocated quantities between the Union and the United Kingdom, based on the apportionments set out in Regulation (EU) 2019/216 and taking into account historic trade flows between those third countries, the Union and the United Kingdom.

                     (4)

                     As the day from which the relevant Article of Regulation (EU) 2019/216 will possibly begin to apply is likely to be a day falling in a quota period that has started running, it is necessary to provide for specific rules for the implementation of the apportionment for the quantities not yet allocated on that day for the tariff rate quotas in respect of which the quota period begins before the day from which Article 1(2) of Regulation (EU) 2019/216 applies and ends after that day. However, in such cases the apportioned tariff rate quota quantities should not exceed the new quantities available for the EU-27 as set out in this Regulation for each tariff rate quota managed by the simultaneous examination method, taking into account the quantities allocated in the Member States other than the United Kingdom before the day from which Article 1(2) of Regulation (EU) 2019/216 applies.

                     (5)

                     In order to ensure legal certainty and transparency for the operators, the Commission should publish the quantities that are available following the apportionment of those tariff rate quotas within two working days from the day from which Article 1(2) of Regulation (EU) 2019/216 applies.

                     (6)

                     It is also necessary to lay down rules on the validity of rights and obligations deriving from import licences issued and import rights allocated by the license issuing authorities of the United Kingdom or by the licence issuing authorities of other Member States.

                     (7)

                     In order to ensure that from the day from which Article 1(2) of Regulation (EU) 2019/216 applies imports under the tariff rate quotas included in the Union's schedule of concessions and commitments annexed to the General Agreement on Tariffs and Trade 1994 are performed only by operators established in the Union, it is necessary to provide for a specific rule concerning the validity of import licences and import rights transferred to operators established in the United Kingdom and not used by that day.

                     (8)

                     In the interest of legal certainty and transparency for the operators, it should be clarified that, except where import licences were issued and import rights were allocated by the licence issuing authorities in the United Kingdom, the Union rules in force as regards rights and obligations deriving from import licences and import rights, including those concerning securities, remain applicable. In addition, rules concerning import licences transferred to operators established in the United Kingdom need to be laid down.

                     (9)

                     The agreement in the form of an Exchange of Letters on the consultations between the European Community and the Kingdom of Thailand under GATT Article XXIII (3), approved by Council Decision 96/317/EC (4), provides for the opening of an additional autonomous annual tariff quota of 10 500 tonnes of manioc starch, of which 10 000 tonnes are reserved for Thailand and 500 tonnes are available for all third countries. For management purposes, those 500 tonnes were added to WTO tariff quota under order number 09.0132 (CN 1108 14 00 manioc starch) that needs to be apportioned in view of the United Kingdom's withdrawal from the Union. In view of this, the tariff quota of 500 tonnes (CN 1108 14 00 manioc starch) needs to be separated from the quantities that should be apportioned in view of the United Kingdom's withdrawal from the Union and as such should be made available under a separate order number.

                     (10)

                     This Regulation should apply from the day from which Article 1(2) of Regulation (EU) 2019/216 applies.

                     (11)

                     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
            Apportionment of tariff rate quotas

               1.   The tariff rate quotas for certain agricultural products included in the Union's schedule of concessions and commitments annexed to the General Agreement on Tariffs and Trade 1994 shall be apportioned between the Union and the United Kingdom as follows:

                           (a)

                           the apportioned quantities of the tariff rate quotas managed by the simultaneous examination method shall be as set out in Annex I;

                           (b)

                           the apportioned quantities of the tariff rate quotas managed by the ‘first come, first served’ method shall be as set out in Annex II.

               2.   The tariff rate quota quantities set out in the Regulations opening the tariff rate quotas referred to in Annexes I and II to this Regulation shall be replaced by the quantities set out in the third column of those Annexes.

               3.   By way of derogation from paragraph 1, where for a tariff rate quota the quota period begins before the day from which Article 1(2) of Regulation (EU) 2019/216 applies and ends after that day, the apportionment of the tariff rate quota concerned shall be made by applying the EU-27 percentage to the quantities of that tariff rate quota available after the last allocation. Taking into account the quantities allocated in the Member States other than the United Kingdom for each such tariff quota in the same quota period before the day from which Article 1(2) of Regulation (EU) 2019/216 applies, the apportioned tariff rate quota quantities shall not exceed the quantities set out in the third column of Annex I to this Regulation for each tariff rate quota managed by the simultaneous examination method.
               Within two working days from the day from which Article 1(2) of Regulation (EU) 2019/216 applies, the Commission shall publish, by means of an appropriate web publication, the quantities available for each tariff rate quota referred to in the first subparagraph of this paragraph on the day from which Article 1(2) of that Regulation applies.

            Article 2
            Import licences issued and import rights allocated before Article 1(2) of Regulation (EU) 2019/216 applies

               1.   Rights and obligations deriving from import licenses issued and import rights allocated by the licensing issuing authorities of the United Kingdom under the tariff rate quotas referred to in Annexes I and II to this Regulation shall expire in the Union as soon as Article 1(2) of Regulation (EU) 2019/216 applies.

               2.   Rights and obligations deriving from import licences issued and import rights allocated by the licencing authorities of Member States other than the United Kingdom under the tariff rate quotas referred to in Annexes I and II to this Regulation shall remain valid in the Union.
               However, where before Article 1(2) of Regulation (EU) 2019/216 applies such licences were transferred to operators established in the United Kingdom, the rights and obligations deriving from those licences shall expire in the Union as soon as Article 1(2) of Regulation (EU) 2019/216 applies.

            Article 3
            Amendment of Commission Regulation (EU) No 1085/2010
            In the Annex to Commission Regulation (EU) No 1085/2010 (5) the following new line is added:

                        Order number

                        CN codes/product

                        Origin

                        Customs duty

                        Annual tariff quota (tonnes, net weight)

                        ‘09.0135

                        1108 14 00
                        Manioc starch

                        All third countries

                        Duty equal to the most favoured nation duty (MFN duty) in force, less EUR 100/tonne

                        500’

            Article 4
            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 from the day from which Article 1(2) of Regulation (EU) 2019/216 applies.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 11 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Regulation (EU) 2019/216 of the European Parliament and of the Council of 30 January 2019 on the apportionment of tariff rate quotas included in the WTO schedule of the Union following the withdrawal of the United Kingdom from the Union and amending Council Regulation (EC) No 32/2000 (OJ L 38, 8.2.2019, p. 1).

            (3)  OJ L 122, 22.5.1996, p. 16.

            (4)  OJ L 122, 22.5.1996, p. 15.

            (5)  Commission Regulation (EU) No 1085/2010 of 25 November 2010 opening and providing for the administration of certain annual tariff quotas for importing sweet potatoes, manioc, manioc starch and other products falling within CN codes 0714 90 11 and 0714 90 19 and amending Regulation (EU) No 1000/2010 (OJ L 310, 26.11.2010, p. 3).

            ANNEX I

               Tariff rate quotas managed by the simultaneous examination method with licences

                        TRQ Order Number

                        Legal basis/Opening Regulation

                        New quantity EU-27

                        EU-27 share in quota (1)

                        09.4451

                        Commission Implementing Regulation (EU) No 593/2013 (2)

                        2 481  tonnes

                        34,7 %

                        09.4450

                        Implementing Regulation (EU) No 593/2013

                        16 936  tonnes

                        99,6 %

                        Implementing Regulation (EU) No 593/2013

                        12 453  tonnes

                        100 %

                        09.4452

                        Implementing Regulation (EU) No 593/2013

                        2 022  tonnes

                        87,9 %

                        Implementing Regulation (EU) No 593/2013

                        3 584  tonnes

                        87,9 %

                        09.4002

                        Implementing Regulation (EU) No 593/2013

                        11 481  tonnes

                        99,8 %

                        09.4455

                        Implementing Regulation (EU) No 593/2013

                        711 tonnes

                        71,1 %

                        09.4454

                        Implementing Regulation (EU) No 593/2013

                        846 tonnes

                        65,1 %

                        09.4453

                        Implementing Regulation (EU) No 593/2013

                        8 951  tonnes

                        89,5 %

                        09.4003

                        Commission Regulation (EC) No 431/2008 (3)

                        43 732  tonnes

                        79,7 %

                        09.4001

                        Implementing Regulation (EU) No 593/2013

                        1 405  tonnes

                        62,4 %

                        09.4004

                        Implementing Regulation (EU) No 593/2013

                        200 tonnes

                        100 %

                        09.4057

                        Commission Regulation (EC) No 412/2008 (4)

                        15 443  tonnes

                        30,9 %

                        09.4058

                        Regulation (EC) No 412/2008

                        4 233  tonnes

                        30,9 %

                        09.4020

                        Commission Regulation (EC) No 748/2008 (5)

                        800 tonnes

                        100 %

                        09.4460

                        Regulation (EC) No 748/2008

                        700 tonnes

                        100 %

                        09.4038

                        Commission Regulation (EC) No 442/2009 (6)

                        12 680  tonnes

                        36 %

                        09.4170

                        Regulation (EC) No 442/2009

                        1 770  tonnes

                        36 %

                        09.4282

                        Commission Implementing Regulation (EU) 2017/1585 (7)

                        Year 2020: 55 548  tonnes
                        Year 2021: 68 048  tonnes
                        From 2022: 80 548  tonnes (8)

                        100 %

                        09.4067

                        Commission Regulation (EC) No 533/2007 (9)

                        4 054  tonnes

                        64,9 %

                        09.4068

                        Regulation (EC) No 533/2007

                        8 253  tonnes

                        96,3 %

                        09.4069

                        Regulation (EC) No 533/2007

                        2 427  tonnes

                        89,7 %

                        09.4410

                        Commission Regulation (EC) No 1385/2007 (10)

                        14 479  tonnes

                        86,7 %

                        09.4411

                        Regulation (EC) No 1385/2007

                        4 432  tonnes

                        86,9 %

                        09.4412

                        Regulation (EC) No 1385/2007

                        2 868  tonnes

                        86,9 %

                        09.4070

                        Regulation (EC) No 533/2007

                        1 781  tonnes

                        100 %

                        09.4420

                        Regulation (EC) No 1385/2007

                        4 227  tonnes

                        86,1 %

                        09.4421

                        Regulation (EC) No 1385/2007

                        597 tonnes

                        85,3 %

                        09.4422

                        Regulation (EC) No 1385/2007

                        2 121  tonnes

                        85,3 %

                        09.4169

                        Commission Regulation (EC) No 536/2007 (11)

                        21 345  tonnes

                        100 %

                        09.4211

                        Commission Regulation (EC) No 616/2007 (12)

                        129 930  tonnes

                        76,1 %

                        09.4212

                        Regulation (EC) No 616/2007

                        68 385  tonnes

                        73,8 %

                        09.4213

                        Regulation (EC) No 616/2007

                        824 tonnes

                        99,5 %

                        09.4217

                        Regulation (EC) No 616/2007

                        89 950  tonnes

                        97,5 %

                        09.4218

                        Regulation (EC) No 616/2007

                        11 301  tonnes

                        97,5 %

                        09.4214

                        Regulation (EC) No 616/2007

                        52 665  tonnes

                        66,3 %

                        09.4215

                        Regulation (EC) No 616/2007

                        109 441  tonnes

                        68,4 %

                        09.4216

                        Regulation (EC) No 616/2007

                        8 471  tonnes

                        74 %

                        09.4251

                        Regulation (EC) No 616/2007

                        10 969  tonnes

                        69,4 %

                        09.4261

                        Regulation (EC) No 616/2007

                        236 tonnes

                        69,4 %

                        09.4252

                        Regulation (EC) No 616/2007

                        59 699  tonnes

                        94,9 %

                        09.4254

                        Regulation (EC) No 616/2007

                        8 019  tonnes

                        57,3 %

                        09.4260

                        Regulation (EC) No 616/2007

                        1 669  tonnes

                        59,6 %

                        09.4253

                        Regulation (EC) No 616/2007

                        163 tonnes

                        55,3 %

                        09.4255

                        Regulation (EC) No 616/2007

                        1 162  tonnes

                        55,3 %

                        09.4262

                        Regulation (EC) No 616/2007

                        260 tonnes

                        55,3 %

                        09.4257

                        Regulation (EC) No 616/2007

                        0 tonnes

                        0 %

                        09.4256

                        Regulation (EC) No 616/2007

                        8 572  tonnes

                        63,5 %

                        09.4263

                        Regulation (EC) No 616/2007

                        159 tonnes

                        72,1 %

                        09.4258

                        Regulation (EC) No 616/2007

                        300 tonnes

                        50 %

                        09.4264

                        Regulation (EC) No 616/2007

                        0 tonnes

                        0 %

                        09.4259

                        Regulation (EC) No 616/2007

                        278 tonnes

                        46,4 %

                        09.4265

                        Regulation (EC) No 616/2007

                        58 tonnes

                        46,4 %

                        09.4015

                        Commission Regulation (EC) No 539/2007 (13)

                        114 669  tonnes

                        84,9 %

                        09.4401

                        Regulation (EC) No 539/2007

                        7 000  tonnes

                        100 %

                        09.4402

                        Regulation (EC) No 539/2007

                        15 500  tonnes

                        100 %

                        09.4590

                        Commission Regulation (EC) No 2535/2001 (14)

                        68 536  tonnes

                        99,998 %

                        09.4599

                        Regulation (EC) No 2535/2001

                        11 360  tonnes

                        100 %

                        09.4182

                        Regulation (EC) No 2535/2001

                        21 230  tonnes

                        63,2 %

                        09.4195

                        Regulation (EC) No 2535/2001

                        25 947  tonnes

                        63,2 %

                        09.4591

                        Regulation (EC) No 2535/2001

                        5 360  tonnes

                        100 %

                        09.4592

                        Regulation (EC) No 2535/2001

                        18 438  tonnes

                        100 %

                        09.4593

                        Regulation (EC) No 2535/2001

                        5 413  tonnes

                        100 %

                        09.4594

                        Regulation (EC) No 2535/2001

                        11 741  tonnes

                        58,7 %

                        09.4515

                        Regulation (EC) No 2535/2001

                        1 670  tonnes

                        41,7 %

                        09.4522

                        Regulation (EC) No 2535/2001

                        500 tonnes

                        100 %

                        09.4595

                        Regulation (EC) No 2535/2001

                        14 941  tonnes

                        99,6 %

                        09.4514

                        Regulation (EC) No 2535/2001

                        4 361  tonnes

                        62,3 %

                        09.4521

                        Regulation (EC) No 2535/2001

                        3 711  tonnes

                        100 %

                        09.4596

                        Regulation (EC) No 2535/2001

                        19 525  tonnes

                        100 %

                        09.4104

                        Commission Regulation (EC) No 341/2007 (15)

                        13 403  tonnes

                        100 %

                        09.4099

                        Regulation (EC) No 341/2007

                        5 744  tonnes

                        100 %

                        09.4105

                        Regulation (EC) No 341/2007

                        28 389  tonnes

                        84,1 %

                        09.4100

                        Regulation (EC) No 341/2007

                        12 167  tonnes

                        84,1 %

                        09.4106

                        Regulation (EC) No 341/2007

                        2 598  tonnes

                        61,6 %

                        09.4102

                        Regulation (EC) No 341/2007

                        1 113  tonnes

                        61,6 %

                        09.4157

                        Commission Regulation (EC) No 1979/2006 (16)

                        28 880  tonnes

                        100 %

                        09.4193

                        Regulation (EC) No 1979/2006

                        1 520  tonnes

                        100 %

                        09.4194

                        Regulation (EC) No 1979/2006

                        252 tonnes

                        100 %

                        09.4158

                        Regulation (EC) No 1979/2006

                        4 779  tonnes

                        100 %

                        09.4123

                        Commission Regulation (EC) No 1067/2008 (17)

                        571 943  tonnes

                        99,99 %

                        09.4125

                        Regulation (EC) No 1067/2008

                        2 285 665  tonnes

                        96,4 %

                        09.4133

                        Regulation (EC) No 1067/2008

                        129 577  tonnes

                        100 %

                        09.4126

                        Commission Regulation (EC) No 2305/2003 (18)

                        306 812  tonnes

                        99,9 %

                        09.4131

                        Commission Regulation (EC) No 969/2006 (19)

                        269 214  tonnes

                        96,8 %

                        09.4120 (20)

                        Commission Regulation (EC) No 1296/2008 (21)

                        500 000  tonnes

                        100 %

                        09.4121 (22)

                        Regulation (EC) No 1296/2008

                        2 000 000  tonnes

                        100 %

                        09.4122 (23)

                        Regulation (EC) No 1296/2008

                        300 000  tonnes

                        100 %

                        09.4148

                        Commission Implementing Regulation (EU) No 1273/2011 (24)

                        1 416  tonnes

                        86,6 %

                        09.4127

                        Implementing Regulation (EU) No 1273/2011

                        15 888  tonnes

                        41 %

                        09.4128

                        Implementing Regulation (EU) No 1273/2011

                        18 798  tonnes

                        87,6 %

                        09.4129

                        Implementing Regulation (EU) No 1273/2011

                        240 tonnes

                        23,5 %

                        09.4130

                        Implementing Regulation (EU) No 1273/2011

                        1 805  tonnes

                        100 %

                        09.4138

                        Implementing Regulation (EU) No 1273/2011

                        — (25)

                        —

                        09.4112

                        Implementing Regulation (EU) No 1273/2011

                        4 682  tonnes

                        84,9 %

                        09.4116

                        Implementing Regulation (EU) No 1273/2011

                        990 tonnes

                        41,5 %

                        09.4117

                        Implementing Regulation (EU) No 1273/2011

                        1 458  tonnes

                        82,4 %

                        09.4118

                        Implementing Regulation (EU) No 1273/2011

                        1 370  tonnes

                        85,9 %

                        09.4119

                        Implementing Regulation (EU) No 1273/2011

                        3 041  tonnes

                        88,5 %

                        09.4166

                        Implementing Regulation (EU) No 1273/2011

                        22 442  tonnes

                        88 %

                        09.4168

                        Implementing Regulation (EU) No 1273/2011

                        26 581  tonnes

                        83,6 %

                        09.4149

                        Implementing Regulation (EU) No 1273/2011

                        48 729  tonnes

                        93,7 %

                        09.4150

                        Implementing Regulation (EU) No 1273/2011

                        14 993  tonnes

                        93,7 %

                        09.4152

                        Implementing Regulation (EU) No 1273/2011

                        10 308  tonnes

                        93,7 %

                        09.4153

                        Implementing Regulation (EU) No 1273/2011

                        8 434  tonnes

                        93,7 %

                        09.4154

                        Implementing Regulation (EU) No 1273/2011

                        11 245  tonnes

                        93,7 %

                        09.4317

                        Commission Regulation (EC) No 891/2009 (26)

                        4 961  tonnes

                        50 %

                        09.4318 (until 2023/2024)

                        Regulation (EC) No 891/2009

                        308 518  (27) tonnes

                        92,4 %

                        09.4318 (as from 2024/2025)

                        Regulation (EC) No 891/2009

                        380 555  (28) tonnes

                        92,4 %

                        09.4319

                        Regulation (EC) No 891/2009

                        68 969  (29) tonnes

                        100 %

                        09.4320

                        Regulation (EC) No 891/2009

                        260 390  (30) tonnes

                        89,8 %

                        09.4321

                        Regulation (EC) No 891/2009

                        5 841  tonnes

                        58,4 %

                        09.4329 (until 2021/2022)

                        Regulation (EC) No 891/2009

                        72 037  (31) tonnes

                        92,4 %

                        09.4329 (2022/2023)

                        Regulation (EC) No 891/2009

                        54 028  (32) tonnes

                        92,4 %

                        09.4330 (2022/2023)

                        Regulation (EC) No 891/2009

                        18 009  (33) tonnes

                        92,4 %

                        09.4330 (2023/2024)

                        Regulation (EC) No 891/2009

                        54 028  (34) tonnes

                        92,4 %

                        09.4079

                        Commission Implementing Regulation (EU) No 480/2012 (35)

                        1 000  tonnes

                        100 %

               (1)  For presentational purposes, the percentage has been rounded to one decimal place. The EU-27 TRQ size is, however, calculated based on the exact percentage.

               (2)  Commission Implementing Regulation (EU) No 593/2013 of 21 June 2013 opening and providing for the administration of tariff quotas for high-quality fresh, chilled and frozen beef and for frozen buffalo meat (OJ L 170, 22.6.2013, p. 32).

               (3)  Commission Regulation (EC) No 431/2008 of 19 May 2008 opening and providing for the administration of an import tariff quota for frozen meat of bovine animals covered by CN code 0202 and products covered by CN code 0206 29 91 (OJ L 130, 20.5.2008, p. 3).

               (4)  Commission Regulation (EC) No 412/2008 of 8 May 2008 opening and providing for the administration of an import tariff quota for frozen beef intended for processing (OJ L 125, 9.5.2008, p. 7).

               (5)  Commission Regulation (EC) No 748/2008 of 30 July 2008 on the opening and administration of an import tariff quota for frozen thin skirt of bovine animals falling within CN code 0206 29 91 (OJ L 202, 31.7.2008, p. 28).

               (6)  Commission Regulation (EC) No 442/2009 of 27 May 2009 opening and providing for the administration of Community tariff quotas in the pigmeat sector (OJ L 129, 28.5.2009, p. 13).

               (7)  Commission Implementing Regulation (EU) 2017/1585 of 19 September 2017 opening and providing for the administration of Union tariff quotas for fresh and frozen beef and veal and pigmeat originating in Canada and amending Regulation (EC) No 442/2009 and Implementing Regulations (EU) No 481/2012 and (EU) No 593/2013 (OJ L 241, 20.9.2017, p. 1).

               (8)  For the year 2019, only the WTO part of this quota (5 549 tonnes carcass weight equivalent) will be apportioned.

               (9)  Commission Regulation (EC) No 533/2007 of 14 May 2007 opening and providing for the administration of tariff quotas in the poultrymeat sector (OJ L 125, 15.5.2007, p. 9).

               (10)  Commission Regulation (EC) No 1385/2007 of 26 November 2007 laying down detailed rules for the application of Council Regulation (EC) No 774/94 as regards opening and providing for the administration of certain Community tariff quotas for poultrymeat (OJ L 309, 27.11.2007, p. 47).

               (11)  Commission Regulation (EC) No 536/2007 of 15 May 2007 opening and providing for the administration of a tariff quota for poultrymeat allocated to the United States of America (OJ L 128, 16.5.2007, p. 6).

               (12)  Commission Regulation (EC) No 616/2007 of 4 June 2007 opening and providing for the administration of Community tariff quotas in the sector of poultrymeat originating in Brazil, Thailand and other third countries (OJ L 142, 5.6.2007, p. 3).

               (13)  Commission Regulation (EC) No 539/2007 of 15 May 2007 opening and providing for the administration of tariff quotas in the egg sector and for egg albumin (OJ L 128, 16.5.2007, p. 19).

               (14)  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).

               (15)  Commission Regulation (EC) No 341/2007 of 29 March 2007 opening and providing for the administration of tariff quotas and introducing a system of import licences and certificates of origin for garlic and certain other agricultural products imported from third countries (OJ L 90, 30.3.2007, p. 12).

               (16)  Commission Regulation (EC) No 1979/2006 of 22 December 2006 opening and providing for the administration of tariff quotas for preserved mushrooms imported from third countries (OJ L 368, 23.12.2006, p. 91).

               (17)  Commission Regulation (EC) No 1067/2008 of 30 October 2008 opening and providing for the administration of Community tariff quotas for common wheat of a quality other than high quality from third countries and derogating from Council Regulation (EC) No 1234/2007 (OJ L 290, 31.10.2008, p. 3).

               (18)  Commission Regulation (EC) No 2305/2003 of 29 December 2003 opening and providing for the administration of a Community tariff quota for imports of barley from third countries (OJ L 342, 30.12.2003, p. 7).

               (19)  Commission Regulation (EC) No 969/2006 of 29 June 2006 opening and providing for the administration of a Community tariff quota for imports of maize from third countries (OJ L 176, 30.6.2006, p. 44).

               (20)  Article 185 of Regulation (EU) No 1308/2013, Portugal.

               (21)  Commission Regulation (EC) No 1296/2008 of 18 December 2008 laying down detailed rules for the application of tariff quotas for imports of maize and sorghum into Spain and imports of maize into Portugal (OJ L 340, 19.12.2008, p. 57).

               (22)  Article 185 of Regulation (EU) No 1308/2013, Spain.

               (23)  Article 185 of Regulation (EU) No 1308/2013, Spain.

               (24)  Commission Implementing Regulation (EU) No 1273/2011 of 7 December 2011 opening and providing for the administration of certain tariff quotas for imports of rice and broken rice (OJ L 325, 8.12.2011, p. 6).

               (25)  Commission Implementing Regulation (EU) No 1273/2011 provides that in October each year the remaining quantities not used in previous sub-periods for import tariff quotas with order numbers 09.4127, 09.4128, 094129 and 09.4130 are allocated erga omnes under import tariff quota number 09.4138.

               (26)  Commission Regulation (EC) No 891/2009 of 25 September 2009 opening and providing for the administration of certain Community tariff quotas in the sugar sector (OJ L 254, 26.9.2009, p. 82).

               (27)  This volume includes the corresponding share of the erga omnes import tariff rate quota number 09.4320 allocated to Brazil by Regulation (EC) No 891/2009.

               (28)  This volume includes the corresponding share of the erga omnes import tariff rate quota number 09.4320 allocated to Brazil by Regulation (EC) No 891/2009.

               (29)  This volume includes the corresponding share of the erga omnes import tariff rate quota number 09.4320 allocated to Cuba by Regulation (EC) No 891/2009.

               (30)  This volume has been deducted from the corresponding shares allocated to Brazil and Cuba by Regulation (EC) No 891/2009.

               (31)  This volume includes the corresponding share of the erga omnes import tariff rate quota number 09.4320 allocated to Brazil by Regulation (EC) No 891/2009.

               (32)  This volume includes the corresponding share of the erga omnes import tariff rate quota number 09.4320 allocated to Brazil by Regulation (EC) No 891/2009.

               (33)  This volume includes the corresponding share of the erga omnes import tariff rate quota number 09.4320 allocated to Brazil by Regulation (EC) No 891/2009.

               (34)  This volume includes the corresponding share of the erga omnes import tariff rate quota number 09.4320 allocated to Brazil by Regulation (EC) No 891/2009.

               (35)  Commission Implementing Regulation (EU) No 480/2012 of 7 June 2012 opening and providing for the management of a tariff quota for broken rice of CN code 1006 40 00 for production of food preparations of CN code 1901 10 00 (OJ L 148, 8.6.2012, p. 1).

            ANNEX II

               Tariff rate quotas managed by the ‘first come, first served’ method

                        TRQ Order Number

                        Legal basis/Opening Regulation

                        New quantity EU-27

                        EU-27 share in quota (1)

                        09.0114

                        Commission Regulation (EC) No 438/2009 (2)

                        710 head

                        100 %

                        09.0115

                        Regulation (EC) No 438/2009

                        711 head

                        100 %

                        09.0113

                        Commission Regulation (EC) No 437/2009 (3)

                        24 070  head

                        100 %

                        09.0122

                        Regulation (EC) No 442/2009

                        15 067  tonnes

                        100 %

                        09.0123

                        Regulation (EC) No 442/2009

                        6 133  tonnes

                        100 %

                        09.0119

                        Regulation (EC) No 442/2009

                        7 000  tonnes

                        100 %

                        09.0118

                        Regulation (EC) No 442/2009

                        3 780  tonnes

                        75,6 %

                        09.0121

                        Regulation (EC) No 442/2009

                        6 161  tonnes

                        100 %

                        09.0120

                        Regulation (EC) No 442/2009

                        164 tonnes

                        5,5 %

                        09.2019
                        09.2181

                        Commission Implementing Regulation (EU) No 1354/2011 (4)

                        92 tonnes

                        100 %

                        09.2011
                        09.2101
                        09.2102

                        Implementing Regulation (EU) No 1354/2011

                        17 006  tonnes

                        73,9 %

                        09.2012
                        09.2105
                        09.2106

                        Implementing Regulation (EU) No 1354/2011

                        3 837  tonnes

                        20 %

                        09.1922
                        09.2115
                        09.2116

                        Implementing Regulation (EU) No 1354/2011

                        For 2019: 7 828  (5) tonnes

                        87,6 %

                        09.0693
                        09.2125
                        09.2126

                        Implementing Regulation (EU) No 1354/2011

                        48 tonnes

                        48,3 %

                        09.2013
                        09.2109
                        09.2110

                        Implementing Regulation (EU) No 1354/2011

                        114 184  tonnes

                        50 %

                        09.2014
                        09.2111
                        09.2112

                        Implementing Regulation (EU) No 1354/2011

                        4 759  tonnes

                        82,1 %

                        09.2015
                        09.2171
                        09.2175

                        Implementing Regulation (EU) No 1354/2011

                        200 tonnes

                        100 %

                        09.2016
                        09.2178
                        09.2179

                        Implementing Regulation (EU) No 1354/2011

                        178 tonnes

                        89,2 %

                        09.0055

                        Commission Regulation (EC) No 1831/96 (6)

                        4 292  tonnes

                        99,9 %

                        09.0094

                        Regulation (EC) No 1831/96

                        464 tonnes

                        98,2 %

                        09.0056

                        Regulation (EC) No 1831/96

                        1 192  tonnes

                        95,8 %

                        09.0059

                        Regulation (EC) No 1831/96

                        500 tonnes

                        44,1 %

                        09.0057

                        Regulation (EC) No 1831/96

                        500 tonnes

                        100 %

                        09.0035

                        Regulation (EC) No 1831/96

                        9 696  tonnes

                        80,8 %

                        09.0708

                        Commission Regulation (EC) No 1475/2007 (7)

                        3 096 027  tonnes

                        53,8 %

                        09.0126

                        Regulation (EC) No 1475/2007

                        0 tonnes

                        0 %

                        09.0127

                        Regulation (EC) No 1475/2007

                        275 805  tonnes

                        78,8 %

                        09.0128

                        Regulation (EC) No 1475/2007

                        124 552  tonnes

                        85,5 %

                        09.0129

                        Regulation (EC) No 1475/2007

                        30 000  tonnes

                        100 %

                        09.0130

                        Regulation (EC) No 1475/2007

                        1 691  tonnes

                        84,6 %

                        09.0124

                        Regulation (EC) No 1475/2007

                        252 641  tonnes

                        42,1 %

                        09.0131

                        Regulation (EC) No 1475/2007

                        4 985  tonnes

                        99,7 %

                        09.0041

                        Regulation (EC) No 1831/96

                        85 958  tonnes

                        95,5 %

                        09.0025

                        Regulation (EC) No 1831/96

                        20 000  tonnes

                        100 %

                        09.0027

                        Regulation (EC) No 1831/96

                        14 931  tonnes

                        99,5 %

                        09.0039

                        Regulation (EC) No 1831/96

                        8 156  tonnes

                        81,6 %

                        09.0060

                        Regulation (EC) No 1831/96

                        885 tonnes

                        59 %

                        09.0061

                        Regulation (EC) No 1831/96

                        666 tonnes

                        95,7 %

                        09.0062

                        Regulation (EC) No 1831/96

                        810 tonnes

                        81 %

                        09.0058

                        Regulation (EC) No 1831/96

                        74 tonnes

                        14,9 %

                        09.0063

                        Regulation (EC) No 1831/96

                        1 387  tonnes

                        55,5 %

                        09.0040

                        Regulation (EC) No 1831/96

                        105 tonnes

                        13,1 %

                        09.0092

                        Regulation (EC) No 1831/96

                        2 820  tonnes

                        99,4 %

                        09.0033

                        Regulation (EC) No 1831/96

                        1 500  tonnes

                        100 %

                        09.0093

                        Regulation (EC) No 1831/96

                        6 436  tonnes

                        91,4 %

                        09.0067

                        Regulation (EC) No 1472/2003

                        0 %

                        09.0074

                        Commission Regulation (EC) No 2133/2001 (8)

                        50 000  tonnes

                        100 %

                        09.0075

                        Regulation (EC) No 2133/2001

                        300 000  tonnes

                        100 %

                        09.0076

                        Commission Regulation (EC) No 1064/2009 (9)

                        20 789  tonnes

                        40,9 %

                        09.2905

                        Commission Regulation (EC) No 440/96 (10)

                        20 000  tonnes

                        100 %

                        09.2903

                        Regulation (EC) No 440/96

                        100 000  tonnes

                        100 %

                        09.0090

                        Commission Regulation (EC) No 937/2006 (11)

                        10 000  tonnes

                        100 %

                        09.0071

                        Regulation (EC) No 2133/2001

                        888 tonnes

                        68,3 %

                        09.0043

                        Commission Regulation (EC) No 2094/2004 (12)

                        231 tonnes

                        2,3 %

                        09.0132

                        Commission Regulation (EU) No 1085/2010 (13)

                        6 632  tonnes

                        82,9 %

                        09.0132

                        Regulation (EU) No 1085/2010

                        1 658  tonnes

                        82,9 %

                        09.0072

                        Regulation (EC) No 2133/2001

                        458 068  tonnes

                        96,4 %

                        09.0083

                        Implementing Regulation (EU) No 1273/2011

                        5 tonnes

                        66,7 %

                        09.0073

                        Regulation (EC) No 2133/2001

                        2 746  tonnes

                        98,1 %

                        09.0070

                        Regulation (EC) No 2133/2001

                        2 670  tonnes

                        98,9 %

                        09.0089

                        Regulation (EC) No 2133/2001

                        1 393  tonnes

                        67,7 %

                        09.0097

                        Commission Regulation (EC) No 218/2007 (14)

                        4 689  hectolitres

                        11,7 %

                        09.0095

                        Regulation (EC) No 218/2007

                        15 647  hectolitres

                        78,2 %

                        09.0098

                        Commission Regulation (EC) No 1518/2007 (15)

                        13 808  hectolitres

                        99,99 %

               (1)  For presentational purposes, the percentage has been rounded to one decimal place. The EU-27 TRQ size is, however, calculated based on the exact percentage.

               (2)  Commission Regulation (EC) No 438/2009 of 26 May 2009 opening and providing for the administration of Community tariff quotas for bulls, cows and heifers other than for slaughter of certain Alpine and mountain breeds (OJ L 128, 27.5.2009, p. 57).

               (3)  Commission Regulation (EC) No 437/2009 of 26 May 2009 opening and providing for the administration of a Community import tariff quota for young male bovine animals for fattening (OJ L 128, 27.5.2009, p. 54).

               (4)  Commission Implementing Regulation (EU) No 1354/2011 of 20 December 2011 opening annual Union tariff quotas for sheep, goats, sheepmeat and goatmeat (OJ L 338, 21.12.2011, p. 36). For sheep tariff quotas opened and managed by this regulation, there are multiple TRQ order numbers associated to a single quantity.

               (5)  Tariff quota for Chile increases by 200 t per annum.

               (6)  Commission Regulation (EC) No 1831/96 of 23 September 1996 opening and providing for the administration of Community tariff quotas bound under GATT for certain fruit and vegetables and processed fruit and vegetable products from 1996 (OJ L 243, 24.9.1996, p. 5).

               (7)  Commission Regulation (EC) No 1475/2007 of 13 December 2007 opening a Community tariff quota from 2008 for manioc originating from Thailand (OJ L 329, 14.12.2007, p. 15).

               (8)  Commission Regulation (EC) No 2133/2001 of 30 October 2001 opening and providing for the administration of certain Community tariff quotas and tariff ceilings in the cereals sector and repealing Regulations (EC) No 1897/94, (EC) No 306/96, (EC) No 1827/96, (EC) No 1970/96, (EC) No 1405/97, (EC) No 1406/97, (EC) No 2492/98, (EC) No 2809/98 and (EC) No 778/1999 (OJ L 287, 31.10.2001, p. 12).

               (9)  Commission Regulation (EC) No 1064/2009 of 4 November 2009 opening and providing for the administration of a Community import tariff quota for malting barley from third countries (OJ L 291, 7.11.2009, p. 14).

               (10)  Commission Regulation (EC) No 440/96 of 11 March 1996 opening and providing for the administration of Community tariff quotas for certain mixtures of malt sprouts and barley screenings (OJ L 61, 12.3.1996, p. 2).

               (11)  Commission Regulation (EC) No 937/2006 of 23 June 2006 opening and providing for the administration of a Community tariff quota of corn gluten originating in the United States of America (OJ L 172, 24.6.2006, p. 9).

               (12)  Commission Regulation (EC) No 2094/2004 of 8 December 2004 opening and providing for the administration of a tariff quota of 10 000 tonnes of oat grains otherwise worked falling within CN code 1104 22 98 (OJ L 362, 9.12.2004, p. 12).

               (13)  Commission Regulation (EU) No 1085/2010 of 25 November 2010 opening and providing for the administration of certain annual tariff quotas for importing sweet potatoes, manioc, manioc starch and other products falling within CN codes 0714 90 11 and 0714 90 19 and amending Regulation (EU) No 1000/2010 (OJ L 310, 26.11.2010, p. 3).

               (14)  Commission Regulation (EC) No 218/2007 of 28 February 2007 opening and providing for the administration of Community tariff quotas for wines (OJ L 62, 1.3.2007, p. 22).

               (15)  Commission Regulation (EC) No 1518/2007 of 19 December 2007 opening and providing for the administration of a tariff quota for vermouth (OJ L 335, 20.12.2007, p. 14).


title: Commission Implementing Regulation (EU) 2019/388 of 11 March 2019 authorising the change of the specifications of the novel food 2′-fucosyllactose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
                  12.3.2019

                  EN

                  Official Journal of the European Union

                  L 70/21

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/388
         of 11 March 2019
         authorising the change of the specifications of the novel food 2′-fucosyllactose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) which establishes a Union list of authorised novel foods was adopted.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising the placing on the Union market of a novel food and updating the Union list.

                     (4)

                     Commission Implementing Decision (EU) 2016/376 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of synthetic 2′-fucosyllactose as a novel food ingredient.

                     (5)

                     Commission Implementing Decision (EU) 2017/2201 (5) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of 2′-fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient.

                     (6)

                     On 23 June 2016, the company Glycom A/S (the Applicant), informed the Commission, pursuant to Article 5 of Regulation (EC) No 258/97, of its intention to place on the market 2′-fucosyllactose produced by bacterial fermentation with Escherichia coli strain K-12.

                     (7)

                     In the notification to the Commission, the Applicant also submitted a report issued on 10 June 2016 by the competent authority of Ireland pursuant to Article 3(4) of Regulation (EC) No 258/97, which, on the basis of the scientific evidence submitted by the Applicant, had concluded that 2′-fucosyllactose produced with Escherichia coli strain K-12 is substantially equivalent to the synthetic 2′-fucosyllactose authorised by Commission Implementing Decision (EU) 2016/376.

                     (8)

                     On 16 August 2018, the Applicant made a request to the Commission to change in the specifications of the 2′-fucosyllactose produced with Escherichia coli strain K-12 within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The requested changes concern a decrease in the levels of the 2′-fucosyllactose from 90 % to 83 %, and increases in the levels of the minor saccharides present in the novel food, namely an increase in the levels of D-lactose from up to 3,0 % to up to 10,0 %, an increase in the levels of difucosyl-D-lactose from up to 2,0 % to up to 5,0 %.

                     (9)

                     To ensure that the overall purity of the novel food following the introduction of the above changes in its specifications, remains as high as the currently authorised 2′-fucosyllactose produced by either Escherichia coli strain K12 or Escherichia coli strain BL 21, the Applicant also proposes that the overall levels of 2′-fucosyllactose together with the minor saccharides (D-lactose, L-fucose, difucosyl-D-lactose, and 2′-fucosyl-D-lactulose) in the novel food is equal or higher than 90,0 %.

                     (10)

                     The proposed changes in the specifications of the novel food are due to the modifications in its manufacturing process that entail the replacement of the crystallisation purification step with a spray drying step which is currently used in the production of 2′-fucosyllactose by Escherichia coli strain BL21. This change in the purification step of the novel food production requires the increase in the use of D-lactose as the fermentation substrate in the production of 2′-fucosyllactose that explains the slight decrease in the level of 2′-fucosyllactose and the concomitant slight increases in the levels of D-lactose and of difucosyl-D-lactose in the final novel food. These proposed changes in the manufacturing are deemed necessary by the Applicant in order to reduce the energy and environmental impact of the 2′-fucosyllactose manufacturing process and to reduce the cost per unit produced.

                     (11)

                     The proposed changes do not alter the safety considerations that supported the authorisation of the 2′-fucosyllactose produced with Escherichia coli strain K-12. Therefore, it is appropriate to amend the specifications of the novel food ‘2′-fucosyllactose’ at the proposed levels of 2′-fucosyllactose, of D-lactose, of difucosyl-D-lactose, and of the overall levels of 2′-fucosyllactose together with the minor saccharides (D-lactose, L-fucose, difucosyl-D-lactose, and 2′-fucosyl-D-lactulose).

                     (12)

                     The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food ‘2′-fucosyllactose’ comply with Article 12 of Regulation (EU) 2015/2283.

                     (13)

                     The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (14)

                     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 entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food 2′-fucosyllactose produced with Escherichia coli strain K-12, shall be amended as specified in 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, 11 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Commission Implementing Decision (EU) 2016/376 of 11 March 2016 authorising the placing on the market of 2′-O-fucosyllactose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 70, 16.3.2016, p. 27).

            (4)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel food and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (5)  Commission Implementing Decision (EU) 2017/2201 of 27 November 2017 authorising the placing on the market of 2′-fucosyllactose produced with Escherichia coli strain BL21 as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 29.11.2017, p. 5).

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
            The entry for ‘2′-Fucosyllactose’ (microbial source) in Table 2 (Specifications) is replaced by the following:

                           ‘Definition:

                           Chemical name: α-L-Fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
                           Chemical formula: C18H32O15

                           CAS No: 41263-94-9
                           Molecular weight: 488,44 g/mol

                              Source:

                           Genetically modified strain of Escherichia coli K-12

                              Source:

                           Genetically modified strain of Escherichia coli BL21

                              Description:

                           2′-Fucosyllactose is a white to off-white powder that is produced by a microbial process.

                              Purity:

                           2′-Fucosyllactose: ≥ 83 %
                           D-Lactose: ≤ 10,0 %
                           L-Fucose: ≤ 2,0 %
                           Difucosyl-D-lactose: ≤ 5,0 %
                           2′-Fucosyl-D-lactulose: ≤ 1,5 %
                           Sum of saccharides (2′-Fucosyllactose, D-Lactose, L-Fucose, Difucosyl-D-lactose, 2′-Fucosyl-D-lactulose): ≥ 90 %
                           pH (20 C, 5 % solution): 3,0-7,5
                           Water: ≤ 9,0 %
                           Sulphated ash: ≤ 2,0 %
                           Acetic acid: ≤ 1,0 %
                           Residual proteins: ≤ 0,01 %

                              Microbiological criteria:

                           Aerobic mesophilic bacteria total count: ≤ 3 000  CFU/g
                           Yeasts: ≤ 100 CFU/g
                           Moulds: ≤ 100 CFU/g
                           Endotoxins: ≤ 10 EU/mg

                              Description:

                           2′-Fucosyllactose is a white to off white powder and the liquid concentrate (45 % ± 5 % w/v) aqueous solution is a colourless to slight yellow clear aqueous solution. 2′-Fucosyllactose is produced by a microbiological process.

                              Purity:

                           2′-Fucosyllactose: ≥ 90 %
                           Lactose: ≤ 5,0 %
                           Fucose: ≤ 3,0 %
                           3-Fucosyllactose: ≤ 5,0 %
                           Fucosylgalactose: ≤ 3,0 %
                           Difucosyllactose: ≤ 5,0 %
                           Glucose: ≤ 3,0 %
                           Galactose: ≤ 3,0 %
                           Water: ≤ 9,0 % (powder)
                           Ash, sulphated: ≤ 0,5 % (powder and liquid)
                           Residual proteins: ≤ 0,01 % (powder and liquid)

                              Heavy Metals:

                           Lead: ≤ 0,02 mg/kg (powder and liquid)
                           Arsenic: ≤ 0,2 mg/kg (powder and liquid)
                           Cadmium: ≤ 0,1 mg/kg (powder and liquid)
                           Mercury: ≤ 0,5 mg/kg (powder and liquid)

                              Microbiological criteria:

                           Total plate count: ≤ 104 CFU/g (powder), ≤ 5 000  CFU/g (liquid)
                           Yeasts and Moulds: ≤ 100 CFU/g (powder); ≤ 50 CFU/g (liquid)
                           Enterobacteriaceae/Coliforms: absence in 11 g (powder and liquid)

                              Salmonella: negative/100 g (powder), negative/200 ml (liquid)

                              Cronobacter: negative/100 g (powder), negative/200 ml (liquid)
                           Endotoxins: ≤ 100 EU/g (powder), ≤ 100 EU/ml (liquid)
                           Aflatoxin M1: ≤ 0,025 μg/kg (powder and liquid)’


title: Commission Implementing Regulation (EU) 2019/646 of 15 April 2019 concerning the classification of certain goods in the Combined Nomenclature

text:
                  25.4.2019

                  EN

                  Official Journal of the European Union

                  L 110/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/646
         of 15 April 2019
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

                     In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

                     (2)

                     Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

                     (3)

                     Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

                     (4)

                     It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 15 April 2019.

                  For the Commission,

                  On behalf of the President,

               Stephen QUEST

                  Director-General

                  Directorate-General for Taxation and Customs Union

            (1)  OJ L 269, 10.10.2013, p. 1.

            (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

            ANNEX

                        Description of the goods

                        Classification
                        (CN code)

                        Reasons

                        (1)

                        (2)

                        (3)

                        Track link assembly (so-called ‘track-chain’) made of cast steel, consisting of track links which are connected by pins/joints. The links have drilled holes for attaching plates of rectangular shape (so-called ‘shoes/pads’), not included upon presentation.
                        The design of the article, mainly the presence of the drilled holes to which the ‘shoes/pads’ are to be attached makes the article identifiable as a caterpillar belt (which both delivers the propulsion and supports the machinery to move on it) suitable for use solely or principally with earth-moving machinery of heading 8429 .
                        (See image) (*1)

                        8431 49 20

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, note 1(f) to Section XV, note 2(b) to Section XVI and by the wording of CN codes 8431 , 8431 49  and 8431 49 20 .
                        Based on its objective characteristics, the article is identifiable as a part being solely or principally suitable for use with machinery of heading 8429  (see also the Harmonised System classification opinion 8431.49/1). The objective characteristics of the article (size and shape) are those of a caterpillar belt designed for use with machinery of heading 8429 . Classification under heading 7315  as chains of iron or steel is consequently excluded.
                        The article is therefore to be classified under CN code 8431 49 20  as other parts suitable for use solely or principally with the machinery of headings 8425  to 8430 ; of cast iron or cast steel.

               (*1)  The image is purely for information.


title: Commission Implementing Regulation (EU) 2019/661 of 25 April 2019 ensuring the smooth functioning of the electronic registry for quotas for placing hydrofluorocarbons on the market (Text with EEA relevance.)

text:
                  26.4.2019

                  EN

                  Official Journal of the European Union

                  L 112/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/661
         of 25 April 2019
         ensuring the smooth functioning of the electronic registry for quotas for placing hydrofluorocarbons on the market
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 (1), and in particular Article 17(2) thereof,
         Whereas:

                     (1)

                     Article 17 of Regulation (EU) No 517/2014 provides for a central electronic registry to manage quotas, for the placing of hydrofluorocarbons on the market, and their reporting, including equipment placed on the market charged with hydrofluorocarbons (‘the registry’).

                     (2)

                     Following the Kigali Amendment to the Montreal Protocol on substances that deplete the ozone layer (2), as from 1 January 2019 Union imports and exports of bulk quantities of hydrofluorocarbons fall under the licensing system set out in Article 4B of the Montreal Protocol. Valid registration of an undertaking acting as importer or exporter, as appropriate, in the registry under Regulation (EU) No 517/2014 is considered to constitute such a licence.

                     (3)

                     In order to ensure the smooth functioning of the registry, it is important to specify the requirements for undertakings for which registration is compulsory. Those requirements should, inter alia, include a requirement to provide information related to the financial and legal status of those undertakings. Such information may be necessary in order to ensure an effective implementation of the quota allocation, avoid distortion of quota allocations and prevent circumvention and abuses of legislative requirements.

                     (4)

                     The different situation of undertakings that have mandated an only representative in accordance with Regulation (EU) No 517/2014 should also be reflected in the registration requirements.

                     (5)

                     In order to allow the quota mechanism for placing hydrofluorocarbons on the market to be implemented effectively by means of the registry it is important to provide safeguards aimed at ensuring that the allocation of quotas is carried out in a lawful and fair manner. The function of the registry is to facilitate effective implementation of the quota mechanism. The registry should therefore be organised and managed in a way that it allows it to be used as a tool to avoid any circumvention or abuse of the requirements for quota allocations. In particular, where the same beneficial owner(s) registers several undertakings with the aim of receiving a higher allocation of quotas than a single undertaking's share of the maximum quantity of hydrofluorocarbons that can be placed on the market in the Union in accordance with Article 15(1) of Regulation (EU) No 517/2014, such undertakings registered with the same beneficial owner(s) should be considered as one for the purposes of the quota allocation stipulated in Article 16(5) of the Regulation. Beneficial ownership can be related to any type of legal entity including for example small and medium-sized enterprises.

                     (6)

                     Taking into account national laws and rules regulating the establishment and operation of undertakings, the Commission needs the assistance of Member States in order to assess the completeness and accuracy of information provided by undertakings for registration purposes. Member States should therefore be required to cooperate and exchange information with the Commission in order to ensure the smooth functioning of the registry.

                     (7)

                     The Commission is required to ensure that personal data submitted pursuant to Article 17 of Regulation (EU) No 517/2014 are processed in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (3).

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 24(1) of Regulation (EU) No 517/2014,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Subject matter
            This Regulation lays down general, operational requirements for registration in the registry established pursuant to Article 17(1) of Regulation (EU) No 517/2014.

            Article 2
            Definitions
            ‘Beneficial owner’ means a beneficial owner as defined in point 6 of Article 3 of Directive (EU) 2015/849 of the European Parliament and of the Council (4).

            Article 3
            Information requirements for registration in the registry

               1.   Undertakings established in the Union shall provide the following information to the Commission for the purposes of becoming registered in the registry:

                           (a)

                           name and legal form of the undertaking as it appears in relevant official documents in line with national laws and practices;

                           (b)

                           the undertaking's full address, including street name and building number, postal code, name of city and country;

                           (c)

                           the undertaking's telephone number, including the international dialling code;

                           (d)

                           the undertaking's VAT number;

                           (e)

                           the undertaking's Economic Operators Registration and Identification (EORI) number, if applicable;

                           (f)

                           the full name of one contact person who satisfies the conditions in points (i) and (ii), and an individual electronic address used for professional purposes by that person containing, if available, a clear link to the undertaking.:

                                       (i)

                                       he or she is either a beneficial owner of, or is employed by, the undertaking;

                                       (ii)

                                       he or she is authorised to perform all obligations and relevant activities relating to the registry on behalf of the undertaking such that they become legally binding on the undertaking;

                           (g)

                           a description of the undertaking's business activities;

                           (h)

                           written confirmation of the undertaking's intention to register in the registry signed by a beneficial owner or employee of the undertaking who is authorised to make legally binding statements on behalf of the undertaking;

                           (i)

                           the undertaking's bank account details validated by means of a document signed by a bank representative or else an original official bank statement relating to a bank account in the Union that is used by the undertaking for its business activities and covers a period within the last 3 months.

               2.   Undertakings established outside the Union that have mandated an only representative as referred to in Article 16(5) of Regulation (EU) No 517/2014 shall provide the following information to the Commission for the purposes of becoming registered in the registry:

                           (a)

                           the information listed in points (a), (b) and (c) of paragraph 1, but with respect to both the undertaking and the only representative, and accompanied, in the case of the information listed in point (a), a relevant official document on which the name and legal form appears in each case, together with a certified translation of that document in English;

                           (b)

                           the information listed in points (d), (e) and (i) of paragraph 1, but with respect to the only representative rather than the undertaking;

                           (c)

                           the full name of one contact who satisfies the conditions in points (i) and (ii), and an individual electronic address used for professional purposes by that person containing, if available, a clear link to the only representative:

                                       (i)

                                       he or she is either a beneficial owner of, or is employed by, the only representative;

                                       (ii)

                                       he or she is authorised to perform all obligations and relevant activities relating to the registry on behalf of the undertaking and the only representative such that they become legally binding on both the undertaking and the only representative;

                           (d)

                           an electronic address for the only representative;

                           (e)

                           a description of the undertaking's business activities;

                           (f)

                           the written confirmation listed in point (h) of paragraph 1 but signed additionally by a beneficial owner or employee of the only representative who is authorised to make legally binding statements on behalf of the only representative;

               3.   In order to be eligible for submitting a declaration pursuant to Article 16(2) or 16(4) of Regulation (EU) No 517/2014 for a given year, the deadlines for submitting and for completing an application to register in the registry shall be as specified in the notice to be issued by the Commission under the third subparagraph of Article 16(2) of that Regulation.

               4.   Undertakings already registered before the entering into force of this Regulation shall submit the information pursuant to paragraphs 1 or 2, whichever is applicable, within 3 months from entering into force of this Regulation, unless it has already been submitted in the registry.

            Article 4
            Additional information requirements for registration in the registry

               1.   The Commission may request an undertaking to provide information on the identity of the beneficial owner(s) of the undertaking, and, where applicable, of the undertaking's only representative, including information as to the type of beneficial ownership and the type and level of control that each such owner is entitled to exercise.

               2.   The Commission may also, where justified after a preliminary assessment of the information provided under Article 3 and, if applicable, under paragraph 1 of this Article request the undertaking to provide the following:

                           (a)

                           additional information or supporting evidence to show the accuracy and completeness of the information provided under Article 3 or, as the case may be, paragraph 1 of this Article;

                           (b)

                           the undertaking's financial statements of the previous year or, if not available, proof of sufficient funds to perform the future activities for which the undertaking wishes to register in the registry;

                           (c)

                           the undertaking's business plan for future activities and an overview of previous business activities;

                           (d)

                           a document providing proof of the management structure of the undertaking;

                           (e)

                           information concerning any links, such as legal, economic or fiscal links, with other undertakings, or the beneficial owners of other undertakings, that have submitted a registration request or are already registered in the registry.

               3.   The Commission may request, where appropriate, that any additional information or supporting evidence requested under paragraph 2 from undertakings that have mandated an only representative be accompanied by a certified translation in English.

               4.   Undertakings shall submit any information or evidence requested under this Article within 10 working days following the date of the request or within such longer period as the Commission may agree following a duly justified request by the undertaking for an extension of time.

            Article 5
            Obligation to update information
            Undertakings registered in the registry shall ensure that the information provided by or on behalf of them under this Regulation is kept up-to-date and shall provide the Commission with updated information as soon as any such information changes or ceases to be complete or accurate.

            Article 6
            Refusal, suspension and cancellation of registrations

               1.   The Commission may refuse to register an undertaking in the registry, or may suspend the registration of an undertaking, if the requirements of this Regulation in relation to that undertaking are not complied with or if any information or evidence provided under this Regulation by or on behalf of the undertaking is inaccurate or incomplete. The concerned undertaking and the competent authority of the relevant Member State shall be informed, via the registry, of the reasons for refusal or suspension of registration.

               2.   Where an undertaking's registration is suspended under paragraph 1, the Commission shall lift the suspension and restore the registration in the event that the requirements of this Regulation in relation to the undertaking are subsequently complied with or, as applicable, the information or evidence provided under this Regulation by or on behalf of the undertaking is subsequently updated so that it is accurate and complete.

               3.   The Commission shall cancel the registration of undertakings in cases where deliberately false information is supplied or if an undertaking, following suspension, persistently fails to provide the required information or to update its information under this Regulation. The concerned undertaking and the competent authority of the relevant Member State shall be informed, via the registry, of the reasons for cancellation of registration.

            Article 7
            Undertakings with the same beneficial owner(s)

               1.   For the purpose of quota allocation for placing hydrofluorocarbons on the market pursuant to Article 16(5) of Regulation (EU) No 517/2014, all undertakings with the same beneficial owner(s) shall be considered as one single declarant in accordance with Article 16(2) and (4) of the Regulation. That single declarant shall be the undertaking that was registered first or, where appropriate, another registered undertaking indicated by the beneficial owner. For the purpose of recalculating reference values pursuant with Article 16(3) of Regulation (EU) No 517/2014, all undertakings with the same beneficial owner(s) shall be considered as one single importer or producer. That single importer or producer shall be the undertaking that was registered first or, where appropriate, another registered undertaking indicated by the beneficial owner.

               2.   For undertakings where paragraph 1 applies for two declaration periods, the Commission shall cancel the registration of the undertakings with the same beneficial owner(s) except for the undertaking that was registered first or, where appropriate, another registered undertaking indicated by the beneficial owner, unless there are other pending obligations in accordance with Regulation (EU) No 517/2014 that require registration to the registry.

            Article 8
            Exchange of information
            Upon request, Member States shall cooperate and exchange information with the Commission when it is necessary for the assessment of the completeness and accuracy of information provided by undertakings for registration purposes under this Regulation, in particular where the information concerns national laws and practices.

            Article 9

               1.   The personal data of an undertaking processed in the registry may be retained for a maximum period of 5 years after the cancellation of the registration in line with Article 6(3).

               2.   The Commission shall ensure by technical means the deletion of personal data in line with paragraph 1.

            Article 10
            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, 25 April 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 150, 20.5.2014, p. 195.

            (2)  Council Decision (EU) 2017/1541 of 17 July 2017 on the conclusion, on behalf of the European Union, of the Kigali Amendment to the Montreal Protocol on substances that deplete the ozone layer, (OJ L 236, 14.9.2017, p. 1).

            (3)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

            (4)  Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing, amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC, OJ L 141, 5.6.2015, p. 73.