# Official Journal L 70/2019

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 70 |
| | |
| English edition | Legislation | Volume 6212 March 2019 |

ISSN 1977-0677

Official Journal

of the European Union

L 70

English edition

Legislation

Volume 6212 March 2019

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Council Decision (EU) 2019/385 of 4 March 2019 on the conclusion of the Protocol on the implementation of the Fisheries Partnership Agreement between the European Union and the Republic of Côte d'Ivoire (2018-2024) | 1 |
| | | REGULATIONS |
| | * | 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 | 4 |
| | * | Commission Implementing Regulation (EU) 2019/387 of 11 March 2019 authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (
  1
  ) | 17 |
| | * | 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 (
  1
  ) | 21 |
| | | DECISIONS |
| | * | Council Decision (EU) 2019/389 of 4 March 2019 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee, concerning the amendment of Annex IX (Financial Services) to the EEA Agreement (Markets in Financial Instruments Regulation (MiFIR) and Directive MiFID II) (
  1
  ) | 25 |
| | * | Decision (EU, Euratom) 2019/390 of the Representatives of the Governments of the Member States of 6 March 2019 appointing a Judge to the Court of Justice | 32 |
| | | ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS |
| | * | Decision No 1/2019 of the Trade and Development Committee established under the Economic Partnership Agreement between the European Union and its Member States, of the one part, and the SADC EPA States, of the other part of 18 February 2019 on the establishment of a list of arbitrators [2019/391] | 33 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Council Decision (EU) 2019/385 of 4 March 2019 on the conclusion of the Protocol on the implementation of the Fisheries Partnership Agreement between the European Union and the Republic of Côte d'Ivoire (2018-2024)

1

REGULATIONS

*

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

4

*

Commission Implementing Regulation (EU) 2019/387 of 11 March 2019 authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (
  1
  )

Schizochytrium

Schizochytrium

1

17

*

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 (
  1
  )

1

21

DECISIONS

*

Council Decision (EU) 2019/389 of 4 March 2019 on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee, concerning the amendment of Annex IX (Financial Services) to the EEA Agreement (Markets in Financial Instruments Regulation (MiFIR) and Directive MiFID II) (
  1
  )

1

25

*

Decision (EU, Euratom) 2019/390 of the Representatives of the Governments of the Member States of 6 March 2019 appointing a Judge to the Court of Justice

32

ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

*

Decision No 1/2019 of the Trade and Development Committee established under the Economic Partnership Agreement between the European Union and its Member States, of the one part, and the SADC EPA States, of the other part of 18 February 2019 on the establishment of a list of arbitrators [2019/391]

33

| | |
| --- | --- |
| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

INTERNATIONAL AGREEMENTS

| 12.3.2019 | EN | Official Journal of the European Union | L 70/1 |
| --- | --- | --- | --- |

12.3.2019

EN

Official Journal of the European Union

L 70/1

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COUNCIL DECISION (EU) 2019/385

of 4 March 2019

on the conclusion of the Protocol on the implementation of the Fisheries Partnership Agreement between the European Union and the Republic of Côte d'Ivoire (2018-2024)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43, in conjunction with Article 218(6)(a)(v) and Article 218(7) thereof,

Having regard to the proposal from the European Commission,

Having regard to the consent of the European Parliament (1),

Whereas:

| (1) | On 17 March 2008, the Council adopted Regulation (EC) No 242/2008 (2) concluding the Fisheries Partnership Agreement between the Republic of Côte d'Ivoire and the European Community (3) (the ‘Agreement’). The Agreement was then tacitly renewed and is still in force. |
| --- | --- |

(1)

On 17 March 2008, the Council adopted Regulation (EC) No 242/2008 (2) concluding the Fisheries Partnership Agreement between the Republic of Côte d'Ivoire and the European Community (3) (the ‘Agreement’). The Agreement was then tacitly renewed and is still in force.

| (2) | The last Protocol to the Agreement expired on 30 June 2018. |
| --- | --- |

(2)

The last Protocol to the Agreement expired on 30 June 2018.

| (3) | The Commission has negotiated, on behalf of the Union, a new Protocol implementing the Agreement (the ‘Protocol’). The Protocol was initialled on 16 March 2018. |
| --- | --- |

(3)

The Commission has negotiated, on behalf of the Union, a new Protocol implementing the Agreement (the ‘Protocol’). The Protocol was initialled on 16 March 2018.

| (4) | In accordance with Council Decision (EU) 2018/1069 (4), the Protocol was signed on 1 August 2018, subject to its conclusion at a later date. |
| --- | --- |

(4)

In accordance with Council Decision (EU) 2018/1069 (4), the Protocol was signed on 1 August 2018, subject to its conclusion at a later date.

| (5) | The Protocol has been applied on a provisional basis as from the date of its signature. |
| --- | --- |

(5)

The Protocol has been applied on a provisional basis as from the date of its signature.

| (6) | The objective of the Protocol is to enable the Union and the Republic of Côte d'Ivoire (‘Côte d'Ivoire’) to work more closely on promoting a sustainable fisheries policy, sound exploitation of fisheries resources in Ivorian waters, and Côte d'Ivoire's efforts to develop a blue economy. |
| --- | --- |

(6)

The objective of the Protocol is to enable the Union and the Republic of Côte d'Ivoire (‘Côte d'Ivoire’) to work more closely on promoting a sustainable fisheries policy, sound exploitation of fisheries resources in Ivorian waters, and Côte d'Ivoire's efforts to develop a blue economy.

| (7) | The Protocol should be approved. |
| --- | --- |

(7)

The Protocol should be approved.

| (8) | Article 9 of the Agreement establishes the Joint Committee responsible for monitoring its implementation (the ‘Joint Committee’). Furthermore, in accordance with Article 5(4) and Articles 6 and 7 of the Protocol, the Joint Committee may approve certain amendments to the Protocol. In order to facilitate the approval of such amendments, the Commission should be empowered, subject to specific conditions, to approve those amendments under a simplified procedure, |
| --- | --- |

(8)

Article 9 of the Agreement establishes the Joint Committee responsible for monitoring its implementation (the ‘Joint Committee’). Furthermore, in accordance with Article 5(4) and Articles 6 and 7 of the Protocol, the Joint Committee may approve certain amendments to the Protocol. In order to facilitate the approval of such amendments, the Commission should be empowered, subject to specific conditions, to approve those amendments under a simplified procedure,

HAS ADOPTED THIS DECISION:

Article 1

The Protocol on the implementation of the Fisheries Partnership Agreement between the European Union and the Republic of Côte d'Ivoire (2018-2024) is hereby approved on behalf of the Union (5).

Article 2

The President of the Council shall, on behalf of the Union, give the notification provided for in Article 14 of the Protocol.

Article 3

Subject to the provisions and conditions set out in the Annex to this Decision, the Commission shall be empowered to approve, on behalf of the Union, the amendments to the Protocol to be adopted by the Joint Committee.

Article 4

This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

Done at Brussels, 4 March 2019.

For the Council

The President

A. ANTON

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(1)  Consent of 12 February 2019 (not yet published in the Official Journal).

1

(2)  Council Regulation (EC) No 242/2008 of 17 March 2008 on the conclusion of the Fisheries Partnership Agreement between the European Community and the Republic of Côte d'Ivoire (OJ L 75, 18.3.2008, p. 51).

2

(3)  
  OJ L 48, 22.2.2008, p. 41.

3

(4)  Council Decision (EU) 2018/1069 of 26 July 2018 on the signing, on behalf of the Union, and provisional application of the Protocol on the implementation of the Fisheries Partnership Agreement between the European Union and the Republic of Côte d'Ivoire (2018-2024) (OJ L 194, 31.7.2018, p. 1).

4

(5)  The Protocol has been published in OJ L 194 of 31.7.2018, p. 3, together with the decision on signature.

5

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ANNEX

SCOPE OF THE EMPOWERMENT AND PROCEDURE FOR ESTABLISHING THE UNION POSITION IN THE JOINT COMMITTEE

| (1) | The Commission shall be authorised to negotiate with the Republic of Côte d'Ivoire and, where appropriate and subject to compliance with point 3, agree on modifications to the Protocol in respect of the following issues:






  (a) | review of fishing opportunities and related provisions in accordance with Articles 6 and 7 of the Protocol; |
| --- | --- | --- |

(1)

(a)

review of fishing opportunities and related provisions in accordance with Articles 6 and 7 of the Protocol;

| (b) | adaption of the arrangements for implementing sectoral support in accordance with Article 6 of the Protocol; |
| --- | --- |

(b)

adaption of the arrangements for implementing sectoral support in accordance with Article 6 of the Protocol;

| (c) | management measures falling within the powers of the Joint Committee in accordance with Article 5(4) of the Protocol. |
| --- | --- |

(c)

management measures falling within the powers of the Joint Committee in accordance with Article 5(4) of the Protocol.

| (2) | In the Joint Committee established under the Agreement, the Union shall:






  (a) | act in accordance with the objectives pursued by the Union within the framework of the Common Fisheries Policy; |
| --- | --- | --- |

(2)

(a)

act in accordance with the objectives pursued by the Union within the framework of the Common Fisheries Policy;

| (b) | promote positions that are consistent with the relevant rules adopted by regional fisheries management organisations and in the context of joint management by coastal States. |
| --- | --- |

(b)

promote positions that are consistent with the relevant rules adopted by regional fisheries management organisations and in the context of joint management by coastal States.

| (3) | When a decision on modifications to the Protocol referred to in point 1 is to be adopted during a Joint Committee meeting, the necessary steps shall be taken to ensure that the position to be expressed on behalf of the Union takes account of the latest statistical, biological and other relevant information transmitted to the Commission.
  To this effect and based on that information, a document setting out the particulars of the proposed Union position shall be transmitted by the Commission services, in sufficient time before the relevant Joint Committee meeting, to the Council or to its preparatory bodies for consideration and approval. |
| --- | --- |

(3)

To this effect and based on that information, a document setting out the particulars of the proposed Union position shall be transmitted by the Commission services, in sufficient time before the relevant Joint Committee meeting, to the Council or to its preparatory bodies for consideration and approval.

| (4) | In respect of the issues referred to in point 1(a), the approval of the envisaged Union position by the Council shall require a qualified majority of votes. In the other cases, the Union position envisaged in the preparatory document shall be deemed to be agreed, unless a number of Member States equivalent to a blocking minority objects during a meeting of the Council's preparatory body or within 20 days from receipt of the preparatory document, whichever occurs earlier. In case of such objection, the matter shall be referred to the Council. |
| --- | --- |

(4)

| (5) | If, in the course of further meetings, including on the spot, it is impossible to reach an agreement in order for the Union position to take account of new elements, the matter shall be referred to the Council or its preparatory bodies. |
| --- | --- |

(5)

| (6) | The Commission is invited to take, in due time, any steps necessary as a follow up to the decision of the Joint Committee, including, where appropriate, publication of the relevant decision in the Official Journal of the European Union and submission of any proposal necessary for the implementation of that decision. |
| --- | --- |

(6)

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REGULATIONS

| 12.3.2019 | EN | Official Journal of the European Union | L 70/4 |
| --- | --- | --- | --- |

12.3.2019

EN

Official Journal of the European Union

L 70/4

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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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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; |
| --- | --- |

(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. |
| --- | --- |

(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:

5

| 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’ |

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

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

1

(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).

2

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

3

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

4

(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).

5

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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 % |

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 % |

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).

---

| 12.3.2019 | EN | Official Journal of the European Union | L 70/17 |
| --- | --- | --- | --- |

12.3.2019

EN

Official Journal of the European Union

L 70/17

---

COMMISSION IMPLEMENTING REGULATION (EU) 2019/387

of 11 March 2019

authorising an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil as a novel food and the change of the designation and of the specific labelling requirement of Schizochytrium sp. (ATCC PTA-9695) oil 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 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. |
| --- | --- |

(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) establishing a Union list of authorised novel foods was adopted. |
| --- | --- |

(2)

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

| (3) | Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list. |
| --- | --- |

(3)

Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

| (4) | Commission Implementing Decision (EU) 2015/545 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market in the Union of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food to be used in a number of foods. |
| --- | --- |

(4)

Commission Implementing Decision (EU) 2015/545 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market in the Union of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food to be used in a number of foods.

| (5) | Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees. |
| --- | --- |

(5)

Commission Implementing Regulation (EU) 2018/1032 (5) extended the authorisation of oil from the microalgae Schizochytrium sp. (T18) as a novel food under Regulation (EU) 2015/2283 to fruit/vegetable purees.

| (6) | On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to change the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium sp. (ATCC PTA-9695) oil to fruit and vegetable purees. |
| --- | --- |

(6)

On 10 September 2018, the company DSM Nutritional Products Europe made a request to the Commission to change the conditions of use of the novel food Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of Schizochytrium sp. (ATCC PTA-9695) oil to fruit and vegetable purees.

| (7) | The proposed extension of use of the novel food does not change the safety considerations that supported the authorisation for extension of use of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 to fruit and vegetable purees and it does not either pose any safety concern. Taking into account those considerations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283. |
| --- | --- |

(7)

The proposed extension of use of the novel food does not change the safety considerations that supported the authorisation for extension of use of Schizochytrium sp. (T18) oil by Implementing Regulation (EU) 2018/1032 to fruit and vegetable purees and it does not either pose any safety concern. Taking into account those considerations, the proposed extension of use complies with Article 12(1) of Regulation (EU) 2015/2283.

| (8) | On 10 September 2018, the company DSM Nutritional Products Europe also made a request to the Commission to authorise the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requests the deletion of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food as listed in the Union list and from the labelling of foods containing it. |
| --- | --- |

(8)

On 10 September 2018, the company DSM Nutritional Products Europe also made a request to the Commission to authorise the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requests the deletion of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food as listed in the Union list and from the labelling of foods containing it.

| (9) | The Applicant considers that the change of the designation and the labelling requirements for Schizochytrium sp. (ATCC PTA-9695) oil is necessary because the indication of the strain ‘(ATCC PTA-9695)’ on the labelling of foods containing Schizochytrium sp. (ATCC PTA-9695) oil is not understandable nor relevant for consumers. |
| --- | --- |

(9)

The Applicant considers that the change of the designation and the labelling requirements for Schizochytrium sp. (ATCC PTA-9695) oil is necessary because the indication of the strain ‘(ATCC PTA-9695)’ on the labelling of foods containing Schizochytrium sp. (ATCC PTA-9695) oil is not understandable nor relevant for consumers.

| (10) | There are four oils from Schizochytrium sp. currently authorised and listed in the Union list of novel foods. However, Schizochytrium sp. (ATCC PTA-9695) oil is the only one for which the strain must be specified on the label. Therefore, the change of the designation and labelling of Schizochytrium sp. (ATCC PTA-9695) oil will ensure consistency in the designation and labelling of all oils from Schizochytrium sp. authorised as novel foods without having a negative impact on human health and consumer interests. |
| --- | --- |

(10)

There are four oils from Schizochytrium sp. currently authorised and listed in the Union list of novel foods. However, Schizochytrium sp. (ATCC PTA-9695) oil is the only one for which the strain must be specified on the label. Therefore, the change of the designation and labelling of Schizochytrium sp. (ATCC PTA-9695) oil will ensure consistency in the designation and labelling of all oils from Schizochytrium sp. authorised as novel foods without having a negative impact on human health and consumer interests.

| (11) | Considering the removal of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil, the wording ‘(ATCC PTA 9695)’ should be included in the specifications as it is necessary for a proper identification of the novel food. Therefore, the specifications of the entry ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be amended accordingly. |
| --- | --- |

(11)

Considering the removal of the mention of the strain ‘(ATCC PTA 9695)’ from the designation of the novel food and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil, the wording ‘(ATCC PTA 9695)’ should be included in the specifications as it is necessary for a proper identification of the novel food. Therefore, the specifications of the entry ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be amended accordingly.

| (12) | The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil, the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil and the subsequent updating of the Union list are not liable to have an effect on human health. |
| --- | --- |

(12)

The Commission did not request an opinion from the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283, as an extension of use of Schizochytrium sp. (ATCC PTA-9695) oil, the change of the designation and of the specific labelling requirement for Schizochytrium sp. (ATCC PTA-9695) oil and the subsequent updating of the Union list are not liable to have an effect on human health.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(13)

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

1.   The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance Schizochytrium sp. (ATCC PTA-9695) oil shall be amended as specified in the Annex to this Regulation.

2.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

Article 2

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to 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, 11 March 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

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

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).

2

(3)  Commission Implementing Decision (EU) 2015/545 of 31 March 2015 authorising the placing on the market of oil from the micro-algae Schizochytrium sp. (ATCC PTA-9695) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 90, 2.4.2015, p. 7).

3

Schizochytrium

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

4

(5)  Commission Implementing Regulation (EU) 2018/1032 of 20 July 2018 authorising the extension of use of oil from the micro algae Schizochytrium sp. as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council, and amending Commission Implementing Regulation (EU) 2017/2470 (OJ L 185, 23.7.2018, p. 9).

5

Schizochytrium

---

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

| (1) | The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 1 (Authorised novel foods) is replaced by the following:









  Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements |
| --- | --- | --- | --- | --- |
| ‘
  Schizochytrium

  sp. (ATCC PTA-9695) oil | Specified food category | Maximum levels of DHA | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’’ | |
| Dairy products except milk-based drinks | 200 mg/100 g or for cheese products 600 mg/100 g |
| Dairy analogues except drinks | 200 mg/100 g or for analogues to cheese products 600 mg/100 g |
| Spreadable fats and dressings | 600 mg/100 g |
| Breakfast cereals | 500 mg/100 g |
| Food Supplements as defined in Directive 2002/46/EC | 250 mg DHA/day for general population |
| 450 mg DHA/day for pregnant and lactating women |
| Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control | 250 mg/meal |
| Milk-based drinks and similar products intended for young children | 200 mg/100 g |
| Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen |
| Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 |
| Foods for special medical purposes as defined in Regulation (EU) No 609/2013 | In accordance with the particular nutritional requirements of the persons for whom the products are intended |
| Bakery products (breads, rolls, and sweet biscuits) | 200 mg/100 g |
| Cereal bars | 500 mg/100 g |
| Cooking fats | 360 mg/100 g |
| Non-alcoholic beverages (including dairy analogue and milk-based drinks) | 80 mg/100 ml |
| Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
| Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013 | 200 mg/100 g | |
| Fruit/vegetable puree | 100 mg/100 g |

(1)

The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 1 (Authorised novel foods) is replaced by the following:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘
  Schizochytrium

  sp. (ATCC PTA-9695) oil

Specified food category

Maximum levels of DHA

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’’

Dairy products except milk-based drinks

200 mg/100 g or for cheese products 600 mg/100 g

Dairy analogues except drinks

200 mg/100 g or for analogues to cheese products 600 mg/100 g

Spreadable fats and dressings

600 mg/100 g

Breakfast cereals

500 mg/100 g

Food Supplements as defined in Directive 2002/46/EC

250 mg DHA/day for general population

450 mg DHA/day for pregnant and lactating women

Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control

250 mg/meal

Milk-based drinks and similar products intended for young children

200 mg/100 g

Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen

Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014

Foods for special medical purposes as defined in Regulation (EU) No 609/2013

In accordance with the particular nutritional requirements of the persons for whom the products are intended

Bakery products (breads, rolls, and sweet biscuits)

200 mg/100 g

Cereal bars

500 mg/100 g

Cooking fats

360 mg/100 g

Non-alcoholic beverages (including dairy analogue and milk-based drinks)

80 mg/100 ml

Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013

200 mg/100 g

Fruit/vegetable puree

100 mg/100 g

| (2) | The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 (Specifications) is replaced by the following:






  Authorised novel food | Specification |
| --- | --- | --- |
| ‘
  Schizochytrium

  sp. (ATCC PTA-9695) oil | The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.
  Peroxide value (PV): ≤ 5,0 meq/kg oil
  Unsaponifiables: ≤ 3,5 %
  Trans-fatty acids: ≤ 2,0 %
  Free fatty acids: ≤ 0,4 %
  Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %
  DHA content: ≥ 35 %’ |

(2)

The entry for ‘Schizochytrium sp. (ATCC PTA-9695) oil’ in Table 2 (Specifications) is replaced by the following:

Authorised novel food

Specification

‘
  Schizochytrium

  sp. (ATCC PTA-9695) oil

The novel food is obtained from the strain ATCC PTA-9695 of the microalgae Schizochytrium sp.

Peroxide value (PV): ≤ 5,0 meq/kg oil

Unsaponifiables: ≤ 3,5 %

Trans-fatty acids: ≤ 2,0 %

Free fatty acids: ≤ 0,4 %

Docosapentaenoic acid (DPA) n-6: ≤ 7,5 %

DHA content: ≥ 35 %’

---

| 12.3.2019 | EN | Official Journal of the European Union | L 70/21 |
| --- | --- | --- | --- |

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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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 %. |
| --- | --- |

(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 %. |
| --- | --- |

(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. |
| --- | --- |

(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). |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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.

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).

2

(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).

3

(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).

4

(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).

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)’ |

‘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)’

---

DECISIONS

| 12.3.2019 | EN | Official Journal of the European Union | L 70/25 |
| --- | --- | --- | --- |

12.3.2019

EN

Official Journal of the European Union

L 70/25

---

COUNCIL DECISION (EU) 2019/389

of 4 March 2019

on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee, concerning the amendment of Annex IX (Financial Services) to the EEA Agreement (Markets in Financial Instruments Regulation (MiFIR) and Directive MiFID II)

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 in conjunction with Article 218(9) thereof,

Having regard to Council Regulation (EC) No 2894/94 of 28 November 1994 concerning arrangements for implementing the Agreement on the European Economic Area (1), and in particular Article 1(3) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994. |
| --- | --- |

(1)

The Agreement on the European Economic Area (2) (‘the EEA Agreement’) entered into force on 1 January 1994.

| (2) | Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex IX to that Agreement, which contains provisions on financial services. |
| --- | --- |

(2)

Pursuant to Article 98 of the EEA Agreement, the EEA Joint Committee may decide to amend, inter alia, Annex IX to that Agreement, which contains provisions on financial services.

| (3) | Regulation (EU) No 600/2014 of the European Parliament and of the Council (3) and Directive 2014/65/EU of the European Parliament and of the Council (4) are to be incorporated into the EEA Agreement. |
| --- | --- |

(3)

Regulation (EU) No 600/2014 of the European Parliament and of the Council (3) and Directive 2014/65/EU of the European Parliament and of the Council (4) are to be incorporated into the EEA Agreement.

| (4) | Annex IX to the EEA Agreement should therefore be amended accordingly. |
| --- | --- |

(4)

Annex IX to the EEA Agreement should therefore be amended accordingly.

| (5) | The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision, |
| --- | --- |

(5)

The position of the Union within the EEA Joint Committee should therefore be based on the attached draft decision,

HAS ADOPTED THIS DECISION:

Article 1

The position to be adopted, on behalf of the Union, within the EEA Joint Committee on the proposed amendment of Annex IX (Financial services) to the EEA Agreement, shall be based on the draft decision of the EEA Joint Committee attached to this Decision.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 4 March 2019.

For the Council

The President

A. ANTON

---

(1)  
  OJ L 305, 30.11.1994, p. 6.

1

(2)  
  OJ L 1, 3.1.1994, p. 3.

2

(3)  Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84).

3

(4)  Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349).

4

---

DRAFT

DECISION OF THE EEA JOINT COMMITTEE No .../2019

of ...

amending Annex IX (Financial services) to the EEA Agreement

THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (‘the EEA Agreement’), and in particular Article 98 thereof,

Whereas:

| (1) | Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (1), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, is to be incorporated into the EEA Agreement. |
| --- | --- |

(1)

Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (1), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, is to be incorporated into the EEA Agreement.

| (2) | Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 amending Regulation (EU) No 600/2014 on markets in financial instruments, Regulation (EU) No 596/2014 on market abuse and Regulation (EU) No 909/2014 on improving securities settlement in the European Union and on central securities depositories (2) is to be incorporated into the EEA Agreement. |
| --- | --- |

(2)

Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 amending Regulation (EU) No 600/2014 on markets in financial instruments, Regulation (EU) No 596/2014 on market abuse and Regulation (EU) No 909/2014 on improving securities settlement in the European Union and on central securities depositories (2) is to be incorporated into the EEA Agreement.

| (3) | Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (3), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, is to be incorporated into the EEA Agreement. |
| --- | --- |

(3)

Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (3), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, is to be incorporated into the EEA Agreement.

| (4) | Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 amending Directive 2014/65/EU on markets in financial instruments (4) is to be incorporated into the EEA Agreement. |
| --- | --- |

(4)

Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 amending Directive 2014/65/EU on markets in financial instruments (4) is to be incorporated into the EEA Agreement.

| (5) | Directive 2014/65/EU repeals Directive 2004/39/EC of the European Parliament and of the Council (5), which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement. |
| --- | --- |

(5)

Directive 2014/65/EU repeals Directive 2004/39/EC of the European Parliament and of the Council (5), which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement.

| (6) | Regulation (EU) No 600/2014 specifies cases in which the European Banking Authority (EBA) and European Securities and Markets Authority (ESMA) may temporarily prohibit or restrict certain financial activities, and lays down conditions thereto, in accordance with Article 9(5) of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (6) and of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (7), respectively. For the purposes of the EEA Agreement, these powers are to be exercised by the EFTA Surveillance Authority as regards the EFTA States, in accordance with points 31g and 31i of Annex IX to the EEA Agreement. To ensure integration of the expertise of EBA and ESMA in the process and consistency between the two pillars of the EEA, such decisions of the EFTA Surveillance Authority will be adopted on the basis of drafts prepared by EBA or ESMA, as the case may be. This will preserve key advantages of supervision by a single authority. |
| --- | --- |

(6)

Regulation (EU) No 600/2014 specifies cases in which the European Banking Authority (EBA) and European Securities and Markets Authority (ESMA) may temporarily prohibit or restrict certain financial activities, and lays down conditions thereto, in accordance with Article 9(5) of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (6) and of Regulation (EU) No 1095/2010 of the European Parliament and of the Council (7), respectively. For the purposes of the EEA Agreement, these powers are to be exercised by the EFTA Surveillance Authority as regards the EFTA States, in accordance with points 31g and 31i of Annex IX to the EEA Agreement. To ensure integration of the expertise of EBA and ESMA in the process and consistency between the two pillars of the EEA, such decisions of the EFTA Surveillance Authority will be adopted on the basis of drafts prepared by EBA or ESMA, as the case may be. This will preserve key advantages of supervision by a single authority.

| (7) | The Contracting Parties share the understanding that this Decision implements the agreement that was reflected in the conclusions (8) of the EU and EEA EFTA Ministers of Finance and Economy of 14 October 2014 regarding the incorporation of the EU ESAs Regulations into the EEA Agreement. |
| --- | --- |

(7)

The Contracting Parties share the understanding that this Decision implements the agreement that was reflected in the conclusions (8) of the EU and EEA EFTA Ministers of Finance and Economy of 14 October 2014 regarding the incorporation of the EU ESAs Regulations into the EEA Agreement.

| (8) | Annex IX to the EEA Agreement should therefore be amended accordingly, |
| --- | --- |

(8)

Annex IX to the EEA Agreement should therefore be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

Annex IX to the EEA Agreement shall be amended as follows:

| 1. | The following is added in point 13b (Directive 2002/92/EC of the European Parliament and of the Council):

  ‘, as amended by:






  — | 32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116.’ |
| --- | --- | --- |

1.

The following is added in point 13b (Directive 2002/92/EC of the European Parliament and of the Council):

‘, as amended by:

—

32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116.’

| 2. | The text of point 31ba (Directive 2004/39/EC of the European Parliament and of the Council) is replaced by the following:

  ‘
  32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, as amended by:






  — | 32016 L 1034: Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 8). |
| --- | --- | --- |

2.

The text of point 31ba (Directive 2004/39/EC of the European Parliament and of the Council) is replaced by the following:

‘
  32014 L 0065: Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349), as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, as amended by:

—

32016 L 1034: Directive (EU) 2016/1034 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 8).

The provisions of the Directive shall, for the purposes of this Agreement, be read with the following adaptations:

| (a) | Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Directive, the EFTA States and their competent authorities, respectively. |
| --- | --- |

(a)

Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Directive, the EFTA States and their competent authorities, respectively.

| (b) | References to members of the ESCB shall be understood to include, in addition to their meaning in the Directive, the national central banks of the EFTA States. |
| --- | --- |

(b)

References to members of the ESCB shall be understood to include, in addition to their meaning in the Directive, the national central banks of the EFTA States.

| (c) | References to other acts in the Directive shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement. |
| --- | --- |

(c)

References to other acts in the Directive shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement.

| (d) | In Article 3(2), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]” and the words “3 July 2019” shall read “five years thereafter”. |
| --- | --- |

(d)

In Article 3(2), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]” and the words “3 July 2019” shall read “five years thereafter”.

| (e) | In Article 16(11), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]”. |
| --- | --- |

(e)

In Article 16(11), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]”.

| (f) | In Article 41(2), the word “Union” shall be replaced by the word “EEA”. |
| --- | --- |

(f)

In Article 41(2), the word “Union” shall be replaced by the word “EEA”.

| (g) | In Article 57:






  (i) | in the second subparagraph of paragraph 5, the words “it shall take action” shall be replaced by the words “ESMA or, as the case may be, the EFTA Surveillance Authority shall take action”; |
| --- | --- | --- |

(g)

In Article 57:

(i)

in the second subparagraph of paragraph 5, the words “it shall take action” shall be replaced by the words “ESMA or, as the case may be, the EFTA Surveillance Authority shall take action”;

| (ii) | in paragraph 6, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”. |
| --- | --- |

(ii)

in paragraph 6, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”.

| (h) | In points (f) and (g) of Article 70(6), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]”. |
| --- | --- |

(h)

In points (f) and (g) of Article 70(6), as regards the EFTA States, the words “2 July 2014” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]”.

| (i) | In Article 79:






  (i) | in the second subparagraph of paragraph 1, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”; |
| --- | --- | --- |

(i)

In Article 79:

(i)

in the second subparagraph of paragraph 1, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”;

| (ii) | in the fifth subparagraph of paragraph 1, the words, “the EFTA Surveillance Authority” shall be inserted after the words “the Commission, ESMA”. |
| --- | --- |

(ii)

in the fifth subparagraph of paragraph 1, the words, “the EFTA Surveillance Authority” shall be inserted after the words “the Commission, ESMA”.

| (j) | In Articles 81(5), 82(2) and 87(1), the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”. |
| --- | --- |

(j)

In Articles 81(5), 82(2) and 87(1), the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”.

| (k) | In Article 86, the words “ESMA, which” shall be replaced by the words “ESMA. ESMA or, as the case may be, the EFTA Surveillance Authority”. |
| --- | --- |

(k)

In Article 86, the words “ESMA, which” shall be replaced by the words “ESMA. ESMA or, as the case may be, the EFTA Surveillance Authority”.

| (l) | In Article 95(1), as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision].”’ |
| --- | --- |

(l)

In Article 95(1), as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision].”’

| 3. | The text of point 31baa (deleted) is replaced by the following:

  ‘
  32014 R 0600: Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, as amended by:






  — | 32016 R 1033: Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 1). |
| --- | --- | --- |

3.

The text of point 31baa (deleted) is replaced by the following:

‘
  32014 R 0600: Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Regulation (EU) No 648/2012 (OJ L 173, 12.6.2014, p. 84), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, as amended by:

—

32016 R 1033: Regulation (EU) 2016/1033 of the European Parliament and of the Council of 23 June 2016 (OJ L 175, 30.6.2016, p. 1).

The provisions of the Regulation shall, for the purposes of this Agreement, be read with the following adaptations:

| (a) | Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Regulation, the EFTA States and their competent authorities, respectively. |
| --- | --- |

(a)

Notwithstanding the provisions of Protocol 1 to this Agreement, and unless otherwise provided for in this Agreement, the terms “Member State(s)” and “competent authorities” shall be understood to include, in addition to their meaning in the Regulation, the EFTA States and their competent authorities, respectively.

| (b) | References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States. |
| --- | --- |

(b)

References to members of the ESCB shall be understood to include, in addition to their meaning in the Regulation, the national central banks of the EFTA States.

| (c) | Unless otherwise provided for in this Agreement, the European Banking Authority (EBA) or the European Securities and Markets Authority (ESMA), as the case may be, and the EFTA Surveillance Authority shall cooperate, exchange information and consult each other for the purposes of the Regulation, in particular prior to taking any action. |
| --- | --- |

(c)

Unless otherwise provided for in this Agreement, the European Banking Authority (EBA) or the European Securities and Markets Authority (ESMA), as the case may be, and the EFTA Surveillance Authority shall cooperate, exchange information and consult each other for the purposes of the Regulation, in particular prior to taking any action.

| (d) | References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement. |
| --- | --- |

(d)

References to other acts in the Regulation shall be considered relevant to the extent and in the form that those acts are incorporated into the Agreement.

| (e) | References to the powers of ESMA under Article 19 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council in the Regulation shall be understood as referring, in the cases provided for in and in accordance with point 31i of this Annex, to the powers of the EFTA Surveillance Authority as regards the EFTA States. |
| --- | --- |

(e)

References to the powers of ESMA under Article 19 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council in the Regulation shall be understood as referring, in the cases provided for in and in accordance with point 31i of this Annex, to the powers of the EFTA Surveillance Authority as regards the EFTA States.

| (f) | In point (e) of Article 1(1):






  (i) | as regards the EFTA States, the words “competent authorities, ESMA and EBA” shall read “competent authorities and the EFTA Surveillance Authority”; |
| --- | --- | --- |

(f)

In point (e) of Article 1(1):

(i)

as regards the EFTA States, the words “competent authorities, ESMA and EBA” shall read “competent authorities and the EFTA Surveillance Authority”;

| (ii) | the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the words “powers of ESMA”. |
| --- | --- |

(ii)

the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the words “powers of ESMA”.

| (g) | In Article 4:






  (i) | in paragraph 4, the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”; |
| --- | --- | --- |

(g)

In Article 4:

(i)

in paragraph 4, the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”;

| (ii) | in paragraph 7, the words “or, as regards waivers granted by competent authorities of the EFTA States, before the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]” shall be inserted after the words “3 January 2018”. |
| --- | --- |

(ii)

in paragraph 7, the words “or, as regards waivers granted by competent authorities of the EFTA States, before the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]” shall be inserted after the words “3 January 2018”.

| (h) | In Articles 7(1), 9(2), 11(1) and 19(1), the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”. |
| --- | --- |

(h)

In Articles 7(1), 9(2), 11(1) and 19(1), the words “and to the EFTA Surveillance Authority” shall be inserted after the words “the Commission”.

| (i) | In Article 36(5):






  (i) | in the first and second sentences, as regards the EFTA States, the word “ESMA” shall read “the EFTA Surveillance Authority”; |
| --- | --- | --- |

(i)

In Article 36(5):

(i)

in the first and second sentences, as regards the EFTA States, the word “ESMA” shall read “the EFTA Surveillance Authority”;

| (ii) | the words “and shall include in the list all notifications received by the EFTA Surveillance Authority” shall be inserted after the words “ESMA shall publish a list of all notifications that it receives”. |
| --- | --- |

(ii)

the words “and shall include in the list all notifications received by the EFTA Surveillance Authority” shall be inserted after the words “ESMA shall publish a list of all notifications that it receives”.

| (j) | In Article 37(2):






  (i) | as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]”; |
| --- | --- | --- |

(j)

In Article 37(2):

(i)

as regards the EFTA States, the words “3 January 2018” shall read “the date of entry into force of Decision of the EEA Joint Committee No .../... of ... [this Decision]”;

| (ii) | the words “Article 101 and 102 TFEU” shall be replaced by the words “Articles 53 and 54 of the EEA Agreement”. |
| --- | --- |

(ii)

the words “Article 101 and 102 TFEU” shall be replaced by the words “Articles 53 and 54 of the EEA Agreement”.

| (k) | In Article 40:






  (i) | as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “ESMA” shall read “the EFTA Surveillance Authority”; |
| --- | --- | --- |

(k)

In Article 40:

(i)

as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “ESMA” shall read “the EFTA Surveillance Authority”;

| (ii) | as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”; |
| --- | --- |

(ii)

as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”;

| (iii) | in paragraph 3, the words “after consulting the public bodies” shall be replaced by the words “after consultation by ESMA of the public bodies”; |
| --- | --- |

(iii)

in paragraph 3, the words “after consulting the public bodies” shall be replaced by the words “after consultation by ESMA of the public bodies”;

| (iv) | in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without ESMA issuing the opinion”; |
| --- | --- |

(iv)

in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without ESMA issuing the opinion”;

| (v) | in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”; |
| --- | --- |

(v)

in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”;

| (vi) | in paragraph 5, the words “The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA's website” shall be inserted after the words “this Article”. |
| --- | --- |

(vi)

in paragraph 5, the words “The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA's website” shall be inserted after the words “this Article”.

| (l) | In Article 41:






  (i) | as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “EBA” shall read “the EFTA Surveillance Authority”; |
| --- | --- | --- |

(l)

In Article 41:

(i)

as regards the EFTA States, in paragraphs 1 to 4, 6 and 7, the word “EBA” shall read “the EFTA Surveillance Authority”;

| (ii) | as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”; |
| --- | --- |

(ii)

as regards the EFTA States, in paragraph 2, the words “Union law” shall read “the EEA Agreement”;

| (iii) | in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without EBA issuing the opinion”; |
| --- | --- |

(iii)

in paragraph 3, the words “without issuing the opinion” shall be replaced by the words “without EBA issuing the opinion”;

| (iv) | in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”; |
| --- | --- |

(iv)

in paragraph 5, the words “any decision to take any action” shall be replaced by the words “each of its decisions to take action”;

| (v) | in paragraph 5, the words “The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on EBA's website” shall be inserted after the words “this Article”. |
| --- | --- |

(v)

in paragraph 5, the words “The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to take any action under this Article. A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on EBA's website” shall be inserted after the words “this Article”.

| (m) | In Article 45:






  (i) | in the paragraph 1, the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”; |
| --- | --- | --- |

(m)

In Article 45:

(i)

in the paragraph 1, the words “or, as regards the EFTA States, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”;

| (ii) | in paragraphs 2, 4, 5, 8 and 9 and in the first subparagraph of paragraph 3, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”; |
| --- | --- |

(ii)

in paragraphs 2, 4, 5, 8 and 9 and in the first subparagraph of paragraph 3, the words “or, as the case may be, the EFTA Surveillance Authority” shall be inserted after the word “ESMA”;

| (iii) | in the second and third subparagraphs of paragraph 3, the words “or, as the case may be, preparing drafts for the EFTA Surveillance Authority,” shall be inserted after the words “before taking any measure”; |
| --- | --- |

(iii)

in the second and third subparagraphs of paragraph 3, the words “or, as the case may be, preparing drafts for the EFTA Surveillance Authority,” shall be inserted after the words “before taking any measure”;

| (iv) | in paragraph 6, the words “any decision” shall read “each of its decisions”; |
| --- | --- |

(iv)

in paragraph 6, the words “any decision” shall read “each of its decisions”;

| (v) | in paragraph 6, the words “The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to impose or renew any measure referred to in paragraph 1(c). A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA's website” shall be inserted after the words “paragraph 1(c)”; |
| --- | --- |

(v)

in paragraph 6, the words “The EFTA Surveillance Authority shall publish on its website notice of each of its own decisions to impose or renew any measure referred to in paragraph 1(c). A reference to the publication of the notice by the EFTA Surveillance Authority shall be posted on ESMA's website” shall be inserted after the words “paragraph 1(c)”;

| (vi) | in paragraph 7, the words “on the ESMA website or, as regards measures taken by the EFTA Surveillance Authority, when the notice is published on the website of the EFTA Surveillance Authority,” shall be inserted after the words “when the notice is published.”’ |
| --- | --- |

(vi)

in paragraph 7, the words “on the ESMA website or, as regards measures taken by the EFTA Surveillance Authority, when the notice is published on the website of the EFTA Surveillance Authority,” shall be inserted after the words “when the notice is published.”’

| 4. | The following indent is added in point 31bc (Regulation (EU) No 648/2012 of the European Parliament and of the Council):






  ‘— | 32014 R 0600: Regulation (EU) No 600/2014 of the European Parliament and of the Council of 15 May 2014 (OJ L 173, 12.6.2014, p. 84), as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54.’ |
| --- | --- | --- |

4.

The following indent is added in point 31bc (Regulation (EU) No 648/2012 of the European Parliament and of the Council):

‘—

Article 2

The texts of Regulations (EU) No 600/2014, as corrected by OJ L 270, 15.10.2015, p. 4, OJ L 187, 12.7.2016, p. 30 and OJ L 278, 27.10.2017, p. 54, and (EU) 2016/1033 and Directives 2014/65/EU, as corrected by OJ L 188, 13.7.2016, p. 28, OJ L 273, 8.10.2016, p. 35 and OJ L 64, 10.3.2017, p. 116, and (EU) 2016/1034 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.

Article 3

This Decision shall enter into force on the day following the last notification under Article 103(1) of the EEA Agreement (*1).

Article 4

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels,

For the EEA Joint Committee

The President

The Secretaries to the EEA Joint Committee

---

(1)  
  OJ L 173, 12.6.2014, p. 84.

1

(2)  
  OJ L 175, 30.6.2016, p. 1.

2

(3)  
  OJ L 173, 12.6.2014, p. 349.

3

(4)  
  OJ L 175, 30.6.2016, p. 8.

4

(5)  
  OJ L 145, 30.4.2004, p. 1.

5

(6)  
  OJ L 331, 15.12.2010, p. 12.

6

(7)  
  OJ L 331, 15.12.2010, p. 84.

7

(8)  Council Conclusions on the EU and EEA EFTA Ministers of Finance and Economy, 14178/1/14 REV 1.

8

(*1)  [No constitutional requirements indicated.] [Constitutional requirements indicated.]

*1

---

Joint Declaration by the Contracting Parties to Decision No .../2019 incorporating Directive 2014/65/EU into the EEA Agreement

The Contracting Parties share the understanding that the incorporation into the EEA Agreement of Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU is without prejudice to national rules of general application concerning the screening for security or public order of foreign direct investment.

---

| 12.3.2019 | EN | Official Journal of the European Union | L 70/32 |
| --- | --- | --- | --- |

12.3.2019

EN

Official Journal of the European Union

L 70/32

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DECISION (EU, Euratom) 2019/390 OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES

of 6 March 2019

appointing a Judge to the Court of Justice

THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 19 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 253 and 255 thereof,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,

Whereas:

| (1) | The terms of office of 14 Judges and five Advocates-General of the Court of Justice expired on 6 October 2018. |
| --- | --- |

(1)

The terms of office of 14 Judges and five Advocates-General of the Court of Justice expired on 6 October 2018.

| (2) | Mr Andreas KUMIN has been nominated for the post of Judge of the Court of Justice. |
| --- | --- |

(2)

Mr Andreas KUMIN has been nominated for the post of Judge of the Court of Justice.

| (3) | The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr Andreas KUMIN to perform the duties of Judge of the Court of Justice, |
| --- | --- |

(3)

The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr Andreas KUMIN to perform the duties of Judge of the Court of Justice,

HAVE ADOPTED THIS DECISION:

Article 1

Mr Andreas KUMIN is hereby appointed Judge to the Court of Justice for the period from the date of entry into force of this Decision to 6 October 2024.

Article 2

This Decision shall enter into force on the date of its publication in the Official Journal of the European Union.

Done at Brussels, 6 March 2019.

The President

L. ODOBESCU

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ACTS ADOPTED BY BODIES CREATED BY INTERNATIONAL AGREEMENTS

| 12.3.2019 | EN | Official Journal of the European Union | L 70/33 |
| --- | --- | --- | --- |

12.3.2019

EN

Official Journal of the European Union

L 70/33

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DECISION No 1/2019 OF THE TRADE AND DEVELOPMENT COMMITTEE ESTABLISHED UNDER THE ECONOMIC PARTNERSHIP AGREEMENT BETWEEN THE EUROPEAN UNION AND ITS MEMBER STATES, OF THE ONE PART, AND THE SADC EPA STATES, OF THE OTHER PART

of 18 February 2019

on the establishment of a list of arbitrators [2019/391]

THE TRADE AND DEVELOPMENT COMMITTEE,

Having regard to the Economic Partnership Agreement between the European Union and its Member States, of the one part, and the SADC EPA States, of the other part (‘the Agreement’), and in particular Articles 94, 100, 103 and 104 thereof,

HAS ADOPTED THIS DECISION:

Article 1

The list of arbitrators provided for in Article 94 of the Agreement, as set out in the Annex to this Decision, is hereby adopted.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at Cape Town, South Africa.

For the Trade and Development Committee

Representative of the SADC EPA States

O. WARD

EU representative

E. SYNOWIEC

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ANNEX

LIST OF ARBITRATORS PROVIDED FOR IN ARTICLE 94 OF THE AGREEMENT

| | Arbitrators selected by the SADC EPA States:






  1. | Boitumelo Sendy GOFHAMODIMO |
| --- | --- | --- |

Arbitrators selected by the SADC EPA States:

1.

Boitumelo Sendy GOFHAMODIMO

| 2. | Leonard Moses PHUTI |
| --- | --- |

2.

Leonard Moses PHUTI

| 3. | Tsotetsi MAKONG |
| --- | --- |

3.

Tsotetsi MAKONG

| 4. | Sakeus AKWEENDA |
| --- | --- |

4.

Sakeus AKWEENDA

| 5. | Faizel ISMAIL |
| --- | --- |

5.

Faizel ISMAIL

| 6. | Kholofelo Ngokoane KUGLER |
| --- | --- |

6.

Kholofelo Ngokoane KUGLER

| 7. | Nkululeko J. HLOPHE |
| --- | --- |

7.

Nkululeko J. HLOPHE

| 8. | Samuel Jay LEVY |
| --- | --- |

8.

Samuel Jay LEVY

| | Arbitrators selected by the EU:






  9. | Jacques BOURGEOIS |
| --- | --- | --- |

Arbitrators selected by the EU:

9.

Jacques BOURGEOIS

| 10. | Claus-Dieter EHLERMANN |
| --- | --- |

10.

Claus-Dieter EHLERMANN

| 11. | Pieter Jan KUIJPER |
| --- | --- |

11.

Pieter Jan KUIJPER

| 12. | Giorgio SACERDOTI |
| --- | --- |

12.

Giorgio SACERDOTI

| 13. | Laurence BOISSON DE CHAZOURNES |
| --- | --- |

13.

Laurence BOISSON DE CHAZOURNES

| 14. | Ramon TORRENT |
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14.

Ramon TORRENT

| 15. | Michael Johannes HAHN |
| --- | --- |

15.

Michael Johannes HAHN

| 16. | Hélène RUIZ FABRI |
| --- | --- |

16.

Hélène RUIZ FABRI

| | Arbitrators jointly selected by the Parties (non-nationals who may act as Chairperson):






  17. | Merit JANOW |
| --- | --- | --- |

Arbitrators jointly selected by the Parties (non-nationals who may act as Chairperson):

17.

Merit JANOW

| 18. | Ichiro ARAKI |
| --- | --- |

18.

Ichiro ARAKI

| 19. | Christian HÄBERLI |
| --- | --- |

19.

Christian HÄBERLI

| 20. | Claus VON WOBESER |
| --- | --- |

20.

Claus VON WOBESER

| 21. | |
| --- | --- |

21.

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