# Official Journal L 79/2019

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 79 |
| | |
| English edition | Legislation | Volume 6221 March 2019 |

ISSN 1977-0677

Official Journal

of the European Union

L 79

English edition

Legislation

Volume 6221 March 2019

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Council Decision (EU) 2019/453 of 19 March 2019 on the signing, on behalf of the Union, of the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro | 1 |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2019/454 of 20 March 2019 concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species (
  1
  ) | 4 |
| | * | Commission Implementing Regulation (EU) 2019/455 of 20 March 2019 making imports of mixtures of urea and ammonium nitrate originating in Russia, Trinidad and Tobago and the United States of America subject to registration | 9 |
| | * | Commission Implementing Regulation (EU) 2019/456 of 20 March 2019 authorising the change of the specifications of the novel food coriander seed oil from Coriandrum sativum under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (
  1
  ) | 13 |
| | | DECISIONS |
| | * | Council Decision (EU) 2019/457 of 19 March 2019 appointing a member, proposed by the Kingdom of Spain, of the Committee of the Regions | 16 |
| | * | Council Decision (EU) 2019/458 of 19 March 2019 amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Banque centrale du Luxembourg | 17 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Council Decision (EU) 2019/453 of 19 March 2019 on the signing, on behalf of the Union, of the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro

1

REGULATIONS

*

Commission Implementing Regulation (EU) 2019/454 of 20 March 2019 concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species (
  1
  )

Bacillus amyloliquefaciens

Bacillus amyloliquefaciens

Aspergillus oryzae

Trichoderma reesei

1

4

*

Commission Implementing Regulation (EU) 2019/455 of 20 March 2019 making imports of mixtures of urea and ammonium nitrate originating in Russia, Trinidad and Tobago and the United States of America subject to registration

9

*

Commission Implementing Regulation (EU) 2019/456 of 20 March 2019 authorising the change of the specifications of the novel food coriander seed oil from Coriandrum sativum under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (
  1
  )

Coriandrum sativum

1

13

DECISIONS

*

Council Decision (EU) 2019/457 of 19 March 2019 appointing a member, proposed by the Kingdom of Spain, of the Committee of the Regions

16

*

Council Decision (EU) 2019/458 of 19 March 2019 amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Banque centrale du Luxembourg

17

| | |
| --- | --- |
| | (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

| 21.3.2019 | EN | Official Journal of the European Union | L 79/1 |
| --- | --- | --- | --- |

21.3.2019

EN

Official Journal of the European Union

L 79/1

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COUNCIL DECISION (EU) 2019/453

of 19 March 2019

on the signing, on behalf of the Union, of the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular points (b) and (d) of Article 77(2) and point (c) of Article 79(2), in conjunction with Article 218(5) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Pursuant to Article 54(4) of Regulation (EU) 2016/1624 of the European Parliament and of the Council (1), in cases where it is envisaged that European Border and Coast Guard teams will be deployed to a third country in actions where the team members will have executive powers, or where other actions in third countries require it, a status agreement is to be concluded by the Union with the third country concerned. That status agreement should cover all aspects that are necessary for carrying out the actions. |
| --- | --- |

(1)

Pursuant to Article 54(4) of Regulation (EU) 2016/1624 of the European Parliament and of the Council (1), in cases where it is envisaged that European Border and Coast Guard teams will be deployed to a third country in actions where the team members will have executive powers, or where other actions in third countries require it, a status agreement is to be concluded by the Union with the third country concerned. That status agreement should cover all aspects that are necessary for carrying out the actions.

| (2) | On 16 October 2017, the Council authorised the Commission to open negotiations with Montenegro for a status agreement on actions carried out by the European Border and Coast Guard Agency in Montenegro (‘the Agreement’). |
| --- | --- |

(2)

On 16 October 2017, the Council authorised the Commission to open negotiations with Montenegro for a status agreement on actions carried out by the European Border and Coast Guard Agency in Montenegro (‘the Agreement’).

| (3) | The negotiations were successfully finalised by the initialling of the Agreement on 5 February 2019. |
| --- | --- |

(3)

The negotiations were successfully finalised by the initialling of the Agreement on 5 February 2019.

| (4) | This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (2); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application. |
| --- | --- |

(4)

This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (2); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

| (5) | This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (3); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application. |
| --- | --- |

(5)

This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (3); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

| (6) | In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law. |
| --- | --- |

(6)

In accordance with Articles 1 and 2 of Protocol No 22 on the position of Denmark, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union, Denmark is not taking part in the adoption of this Decision and is not bound by it or subject to its application. Given that this Decision builds upon the Schengen acquis, Denmark shall, in accordance with Article 4 of that Protocol, decide within a period of six months after the Council has decided on this Decision whether it will implement it in its national law.

| (7) | Therefore, the Agreement should be signed and the annexed joint declaration should be approved, |
| --- | --- |

(7)

Therefore, the Agreement should be signed and the annexed joint declaration should be approved,

HAS ADOPTED THIS DECISION:

Article 1

The signing on behalf of the Union of the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro is hereby authorised, subject to the conclusion of the said Agreement (4).

Article 2

The joint declaration annexed to this Decision shall be approved on behalf of the Union.

Article 3

The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement on behalf of the Union.

Article 4

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

Done at Brussels, 19 March 2019.

For the Council

The President

G. CIAMBA

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(1)  Regulation (EU) 2016/1624 of the European Parliament and of the Council of 14 September 2016 on the European Border and Coast Guard and amending Regulation (EU) 2016/399 of the European Parliament and of the Council and repealing Regulation (EC) No 863/2007 of the European Parliament and of the Council, Council Regulation (EC) No 2007/2004 and Council Decision 2005/267/EC (OJ L 251, 16.9.2016, p. 1).

1

(2)  Council Decision 2000/365/EC of 29 May 2000 concerning the request of the United Kingdom of Great Britain and Northern Ireland to take part in some of the provisions of the Schengen acquis (OJ L 131, 1.6.2000, p. 43).

2

acquis

(3)  Council Decision 2002/192/EC of 28 February 2002 concerning Ireland's request to take part in some of the provisions of the Schengen acquis (OJ L 64, 7.3.2002, p. 20).

3

acquis

(4)  The text of the Agreement will be published together with the decision on its conclusion.

4

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ANNEX

JOINT DECLARATION WITH REGARD TO ICELAND, NORWAY, SWITZERLAND AND LIECHTENSTEIN

The Parties to the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro take note of the close relationship between the European Union and Norway, Iceland, Switzerland and Liechtenstein, particularly by virtue of the Agreements of 18 May 1999 and 26 October 2004 concerning the association of those countries with the implementation, application and development of the Schengen acquis.

In such circumstances it is desirable that the authorities of Norway, Iceland, Switzerland and Liechtenstein, on the one hand, and Montenegro, on the other hand, conclude, without delay, bilateral agreements on actions carried out by the European Border and Coast Guard Agency in Montenegro in terms similar to those of the Status Agreement between the European Union and Montenegro on actions carried out by the European Border and Coast Guard Agency in Montenegro.

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REGULATIONS

| 21.3.2019 | EN | Official Journal of the European Union | L 79/4 |
| --- | --- | --- | --- |

21.3.2019

EN

Official Journal of the European Union

L 79/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/454

of 20 March 2019

concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(7) of Regulation (EC) No 1831/2003 in conjunction with Article 10(1) to (4) thereof sets out specific provisions for the evaluation of products used in the Union as silage additives.

| (2) | In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of alpha-amylase (EC 3.2.1.1) produced by the following strains of Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 were entered in the Register of feed additives as existing products belonging to the functional group of silage additives, for all animal species. |
| --- | --- |

(2)

In accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003, the preparations of alpha-amylase (EC 3.2.1.1) produced by the following strains of Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 were entered in the Register of feed additives as existing products belonging to the functional group of silage additives, for all animal species.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the three preparations of alpha-amylase (EC 3.2.1.1) and a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) as feed additives for all animal species. |
| --- | --- |

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the three preparations of alpha-amylase (EC 3.2.1.1) and a preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) as feed additives for all animal species.

| (4) | The application concerns the authorisation of preparations of alpha-amylase (EC 3.2.1.1) produced by Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 as feed additives for all animal species, to be classified in the additive category ‘technological additives’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The application concerns the authorisation of preparations of alpha-amylase (EC 3.2.1.1) produced by Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 as feed additives for all animal species, to be classified in the additive category ‘technological additives’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 March 2018 (2) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations concerned have the potential to improve the production of silage from easy, moderate and difficult to ensile forage materials. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 7 March 2018 (2) that, under the proposed conditions of use, the preparations concerned do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations concerned have the potential to improve the production of silage from easy, moderate and difficult to ensile forage materials. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of the preparations of alpha-amylase (EC 3.2.1.1) produced by Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 show that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of the preparations of alpha-amylase (EC 3.2.1.1) produced by Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251 or by Aspergillus oryzae ATCC SD-5374 as well as the preparation of endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Trichoderma reesei ATCC PTA-10001 show that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex to this Regulation.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(7)

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparations specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 March 2019.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  EFSA Journal 2018; 16(4):5224.

2

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ANNEX

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Units of activity of additive/kg of fresh material |
| Technological additives: silage additives |
| 1k101 | Alpha-amylase
  (EC 3.2.1.1) | Additive composition

  Preparation of alpha-amylase produced by:

  Bacillus amyloliquefaciens DSM 9553, having a minimum activity of 129 800 DNS (1)/g additive
  Solid form

  Characterisation of the active substance

  Alpha-amylase produced by Bacillus amyloliquefaciens DSM 9553

  Analytical method
   (2)

  For the determination of alpha-amylase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the starch at pH 4,5 and 37 °C | All animal species | — | — | — | 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity of additive/kg of fresh material

Technological additives: silage additives

1k101

Alpha-amylase

(EC 3.2.1.1)

Additive composition

Preparation of alpha-amylase produced by:

Bacillus amyloliquefaciens DSM 9553, having a minimum activity of 129 800 DNS (1)/g additive

Solid form

Characterisation of the active substance

Alpha-amylase produced by Bacillus amyloliquefaciens DSM 9553

Analytical method
   (2)

For the determination of alpha-amylase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the starch at pH 4,5 and 37 °C

All animal species

—

—

—

1.

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

| 2. | Minimum dose of alpha-amylase when used without combination with other enzymes or microorganisms as silage additives 40 DNS/kg of fresh material. |
| --- | --- |

2.

Minimum dose of alpha-amylase when used without combination with other enzymes or microorganisms as silage additives 40 DNS/kg of fresh material.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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

11 April 2029

1k102

Alpha-amylase

(EC 3.2.1.1)

Additive composition

Preparation of alpha-amylase produced by Bacillus amyloliquefaciens NCIMB 30251, having a minimum activity of 101 050 DNS/g additive

Solid form

Characterisation of the active substance

Alpha-amylase produced by Bacillus amyloliquefaciens NCIMB 30251

Analytical method
   (2)

For the determination of alpha-amylase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the starch at pH 4,5 and 37 °C

All animal species

—

—

—

| 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

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

| 2. | Minimum dose of alpha-amylase when used without combination with other enzymes or microorganisms as silage additives 10 DNS/kg of fresh material. |
| --- | --- |

2.

Minimum dose of alpha-amylase when used without combination with other enzymes or microorganisms as silage additives 10 DNS/kg of fresh material.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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

11 April 2029

1k103

Alpha-amylase

(EC 3.2.1.1)

Additive composition

Preparation of alpha-amylase produced by Aspergillus oryzae ATCC SD-5374 having a minimum activity of 235 850 DNS/g additive

Solid forms

Characterisation of the active substance

Alpha-amylase produced by Aspergillus oryzae ATTC SD-5374

Analytical method
   (2)

For the determination of alpha-amylase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the starch at pH 4,5 and 37 °C

All animal species

—

—

—

| 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

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

| 2. | Minimum dose of alpha-amylase when used without combination with other enzymes or microorganisms as silage additives 23 DNS/kg of fresh material. |
| --- | --- |

2.

Minimum dose of alpha-amylase when used without combination with other enzymes or microorganisms as silage additives 23 DNS/kg of fresh material.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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

11 April 2029

1k104

Endo-1,4-beta-glucanase

(EC 3.2.1.4)

Additive composition

Preparation of endo-1,4-beta-glucanase produced by Trichoderma reesei ATCC PTA-10001 having a minimum activity of 2 750  DNS (3)/g additive

Solid form

Characterisation of the active substance

Endo-1,4-beta-glucanase produced by Trichoderma reesei ATCC PTA-10001

Analytical method
   (2)

For the determination of endo-1,4-beta-glucanase in the feed additive: colorimetric (DNS) method based on the enzymatic hydrolysis of the carboxymethyl cellulose (CMC) at pH 4,5 and 37 °C

All animal species

—

—

—

| 1. | In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

1.

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

| 2. | Minimum dose of endo-1,4-beta-glucanase when used without combination with other enzymes or microorganisms as silage additives 7 DNS/kg of fresh material. |
| --- | --- |

2.

Minimum dose of endo-1,4-beta-glucanase when used without combination with other enzymes or microorganisms as silage additives 7 DNS/kg of fresh material.

| 3. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection. |
| --- | --- |

3.

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

11 April 2029

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(1)  1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as maltose equivalents in μmol per g per min at pH 4,5 and 37 °C from starch under specified conditions of the assay.

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

(3)  1 DNS (3,5-dinitrosalicylic acid) unit is the amount of reducing sugar released as glucose equivalents in μmol per g per min at pH 4,5 and 37 °C from carboxymethyl cellulose (CMC) under specified conditions of the assay.

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| 21.3.2019 | EN | Official Journal of the European Union | L 79/9 |
| --- | --- | --- | --- |

21.3.2019

EN

Official Journal of the European Union

L 79/9

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COMMISSION IMPLEMENTING REGULATION (EU) 2019/455

of 20 March 2019

making imports of mixtures of urea and ammonium nitrate originating in Russia, Trinidad and Tobago and the United States of America subject to registration

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) as last amended by Regulation (EU) 2018/825 of the European Parliament and of the Council of 30 May 2018 (2) (the ‘basic Regulation’), and in particular Article 14(5a) thereof,

After informing the Member States,

Whereas:

| (1) | On 13 August 2018, the European Commission (‘the Commission’) announced, by a notice published in the Official Journal of the European Union (3) (‘the notice of initiation’), the initiation of an anti-dumping proceeding with regard to imports into the Union of mixtures of urea and ammonium nitrate originating in Russia, Trinidad and Tobago and the United States of America following a complaint lodged on 29 June 2018 by Fertilizers Europe (‘the complainant’) on behalf of producers representing more than 25 % of the total Union production of urea and ammonium nitrate solutions. |
| --- | --- |

(1)

On 13 August 2018, the European Commission (‘the Commission’) announced, by a notice published in the Official Journal of the European Union (3) (‘the notice of initiation’), the initiation of an anti-dumping proceeding with regard to imports into the Union of mixtures of urea and ammonium nitrate originating in Russia, Trinidad and Tobago and the United States of America following a complaint lodged on 29 June 2018 by Fertilizers Europe (‘the complainant’) on behalf of producers representing more than 25 % of the total Union production of urea and ammonium nitrate solutions.

1.   PRODUCT SUBJECT TO REGISTRATION

PRODUCT SUBJECT TO REGISTRATION

| (2) | The product subject to registration (‘the product concerned’) is mixtures of urea and ammonium nitrate in aqueous or ammoniacal solution (‘UAN’), currently falling within CN code 3102 80 00. |
| --- | --- |

(2)

The product subject to registration (‘the product concerned’) is mixtures of urea and ammonium nitrate in aqueous or ammoniacal solution (‘UAN’), currently falling within CN code 3102 80 00.

2.   GROUNDS FOR REGISTRATION

GROUNDS FOR REGISTRATION

| (3) | According to Article 14(5a) of the basic Regulation, the Commission must direct the customs authorities to take the appropriate steps to register imports during the period of pre-disclosure under Article 19a, so that measures may subsequently be applied against those imports from the date of such registration, unless it has sufficient evidence that the requirements either under Article 10(4)(c) or Article 10(4)(d) are not met. |
| --- | --- |

(3)

According to Article 14(5a) of the basic Regulation, the Commission must direct the customs authorities to take the appropriate steps to register imports during the period of pre-disclosure under Article 19a, so that measures may subsequently be applied against those imports from the date of such registration, unless it has sufficient evidence that the requirements either under Article 10(4)(c) or Article 10(4)(d) are not met.

| (4) | The Commission verified whether the importers were aware, or should have been aware, of the dumping as regards the extent of the dumping and the injury alleged or found. It also analysed whether there was a further substantial rise in imports which, in the light of its timing and volume and other circumstances, was likely to seriously undermine the remedial effect of the definitive anti-dumping duty to be applied. |
| --- | --- |

(4)

The Commission verified whether the importers were aware, or should have been aware, of the dumping as regards the extent of the dumping and the injury alleged or found. It also analysed whether there was a further substantial rise in imports which, in the light of its timing and volume and other circumstances, was likely to seriously undermine the remedial effect of the definitive anti-dumping duty to be applied.

| (5) | The Commission thus examined the evidence at its disposal in light of Article 10(4) of the basic Regulation. For this analysis, the Commission relied on the statistical data of imports under CN code 3102 80 00 at its disposal. |
| --- | --- |

(5)

The Commission thus examined the evidence at its disposal in light of Article 10(4) of the basic Regulation. For this analysis, the Commission relied on the statistical data of imports under CN code 3102 80 00 at its disposal.

| (6) | On 30 January 2019, the Commission also invited interested parties to comment on its preliminary findings with regard to import trends after the initiation of the investigation and these comments have also been included in its analysis. |
| --- | --- |

(6)

On 30 January 2019, the Commission also invited interested parties to comment on its preliminary findings with regard to import trends after the initiation of the investigation and these comments have also been included in its analysis.

2.1.   Awareness of the importers of the dumping, the extent thereof and the alleged injury

Awareness of the importers of the dumping, the extent thereof and the alleged injury

| (7) | The Commission has at its disposal sufficient evidence that imports of the product concerned from Russia, Trinidad and Tobago and the United States of America are being dumped. |
| --- | --- |

(7)

The Commission has at its disposal sufficient evidence that imports of the product concerned from Russia, Trinidad and Tobago and the United States of America are being dumped.

| (8) | The notice of initiation for this proceeding published on 13 August 2018 highlighted that the dumping margins calculated are significant for all countries. As a whole, and given the extent of the alleged dumping margins ranging from 43 % to 83 %, the evidence in the complaint provides sufficient support at this stage that the exporting producers practice dumping. |
| --- | --- |

(8)

The notice of initiation for this proceeding published on 13 August 2018 highlighted that the dumping margins calculated are significant for all countries. As a whole, and given the extent of the alleged dumping margins ranging from 43 % to 83 %, the evidence in the complaint provides sufficient support at this stage that the exporting producers practice dumping.

| (9) | The complaint also provided sufficient evidence of alleged injury to the Union industry, including a decline in market share and a negative development of other key performance indicators of the Union industry. |
| --- | --- |

(9)

The complaint also provided sufficient evidence of alleged injury to the Union industry, including a decline in market share and a negative development of other key performance indicators of the Union industry.

| (10) | By its publication in the Official Journal of the European Union, the notice of initiation is a public document accessible to all importers. Furthermore, as interested parties in the investigation, importers have access to the non-confidential version of the complaint and the non-confidential file. Therefore, the Commission considered that, on this basis, the importers were aware, or should have been aware, of the alleged dumping practices, the extent thereof and the alleged injury. |
| --- | --- |

(10)

By its publication in the Official Journal of the European Union, the notice of initiation is a public document accessible to all importers. Furthermore, as interested parties in the investigation, importers have access to the non-confidential version of the complaint and the non-confidential file. Therefore, the Commission considered that, on this basis, the importers were aware, or should have been aware, of the alleged dumping practices, the extent thereof and the alleged injury.

Official Journal of the European Union

| (11) | Several exporting producers argued that Article 10(4)(c) was not met as there had not been a history of dumping. However, Article 10(4)(c) mandates that either there has been a history of dumping or that there was awareness of the extent of the dumping and injury alleged. As explained in recitals 7)to 10, on the basis of the notice of initiation and the information contained in the complaint, the Commission considered that the importers were aware, or should have been aware, of the alleged dumping practices, the extent thereof and the alleged injury. |
| --- | --- |

(11)

Several exporting producers argued that Article 10(4)(c) was not met as there had not been a history of dumping. However, Article 10(4)(c) mandates that either there has been a history of dumping or that there was awareness of the extent of the dumping and injury alleged. As explained in recitals 7)to 10, on the basis of the notice of initiation and the information contained in the complaint, the Commission considered that the importers were aware, or should have been aware, of the alleged dumping practices, the extent thereof and the alleged injury.

| (12) | On the basis of the above, the Commission concluded that there is no evidence that the requirement of Article 10(4)(c) of the basic Regulation was not met. |
| --- | --- |

(12)

On the basis of the above, the Commission concluded that there is no evidence that the requirement of Article 10(4)(c) of the basic Regulation was not met.

2.2.   Further substantial rise in imports

Further substantial rise in imports

| (13) | On the basis of statistical data summarised in table 1 below, the Commission found that the volume of UAN imports from the countries concerned into the Union increased by 23 % during the period September 2018-December 2018, i.e. after initiation of the case, when compared to the period September 2017-December 2017, i.e. the same period of the previous year and part of the investigation period (period going from 1 July 2017 to 30 June 2018). In addition, the average monthly volume of imports from the countries concerned into the Union in the period from September 2018 to December 2018 was 34 % higher than the average monthly volume of imports to the Union during the investigation period. Therefore, in view of this further substantial rise in imports from the countries concerned, the Commission concluded that there is no evidence that this requirement was not met.

  Table 1


  Import volumes (MT)












  Origin | September 2017 — December 2017 | September 2018 — December 2018 | Δ | Monthly average investigation period | Average
  September 2018 — December 2018 | Δ |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Russia | 226 319 | 270 449 | + 19,5 % | 51 491 | 67 612 | + 31,3 % |
| Trinidad & Tobago | 150 497 | 167 852 | + 11,5 % | 30 681 | 41 963 | + 36,8 % |
| USA | 200 757 | 333 393 | + 66,1 % | 61 848 | 83 348 | + 34,8 % |
| All 3 | 577 573 | 771 694 | + 33,6 % | 144 020 | 192 924 | + 34,0 % |
| Source: Eurostat |

(13)

On the basis of statistical data summarised in table 1 below, the Commission found that the volume of UAN imports from the countries concerned into the Union increased by 23 % during the period September 2018-December 2018, i.e. after initiation of the case, when compared to the period September 2017-December 2017, i.e. the same period of the previous year and part of the investigation period (period going from 1 July 2017 to 30 June 2018). In addition, the average monthly volume of imports from the countries concerned into the Union in the period from September 2018 to December 2018 was 34 % higher than the average monthly volume of imports to the Union during the investigation period. Therefore, in view of this further substantial rise in imports from the countries concerned, the Commission concluded that there is no evidence that this requirement was not met.

Table 1

Table 1

Import volumes (MT)

Import volumes (MT)

Origin

September 2017 — December 2017

September 2018 — December 2018

Δ

Monthly average investigation period

Average

September 2018 — December 2018

Δ

Russia

226 319

270 449

- 19,5 %

51 491

67 612

- 31,3 %

Trinidad & Tobago

150 497

167 852

- 11,5 %

30 681

41 963

- 36,8 %

USA

200 757

333 393

- 66,1 %

61 848

83 348

- 34,8 %

All 3

577 573

771 694

- 33,6 %

144 020

192 924

- 34,0 %

Source: Eurostat

Source:

2.3.   Undermining of the remedial effect of the duty

Undermining of the remedial effect of the duty

| (14) | As concluded in section 2.2, there was a further substantial increase in imports of the product concerned since the initiation of the current investigation. Those volumes represent more than 48 000 additional metric tonnes on a monthly basis as compared with the volumes imported from the countries concerned during the investigation period. This increase alone represents 10 % of Union consumption in 2017. |
| --- | --- |

(14)

As concluded in section 2.2, there was a further substantial increase in imports of the product concerned since the initiation of the current investigation. Those volumes represent more than 48 000 additional metric tonnes on a monthly basis as compared with the volumes imported from the countries concerned during the investigation period. This increase alone represents 10 % of Union consumption in 2017.

| (15) | According to the import statistics summarised in table 2 below, the average price in euros per metric tonne of imports from the countries concerned into the Union during the period September 2018 to December 2018 was 19,5 % higher than the average import price from these countries observed during the investigation period. A steep increase in import prices could be observed for imports from each of the countries subject to the investigation.

  Table 2


  Import prices (average, EUR/MT)












  Origin | September 2017 — December 2017 | September 2018 — December 2018 | Δ | Monthly average investigation period | Average
  September 2018 — December 2018 | Δ |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Russia | 129,1 | 160,1 | + 24,0 % | 125,9 | 160,1 | + 27,2 % |
| Trinidad & Tobago | 136,0 | 175,4 | + 28,9 % | 139,8 | 175,4 | + 25,4 % |
| USA | 118,0 | 136,6 | + 15,7 % | 124,5 | 136,6 | + 9,7 % |
| All 3 | 127,1 | 153,3 | + 20,6 % | 128,3 | 153,3 | + 19,5 % |
| Source: Eurostat. |

(15)

According to the import statistics summarised in table 2 below, the average price in euros per metric tonne of imports from the countries concerned into the Union during the period September 2018 to December 2018 was 19,5 % higher than the average import price from these countries observed during the investigation period. A steep increase in import prices could be observed for imports from each of the countries subject to the investigation.

Table 2

Table 2

Import prices (average, EUR/MT)

Import prices (average, EUR/MT)

Origin

September 2017 — December 2017

September 2018 — December 2018

Δ

Monthly average investigation period

Average

September 2018 — December 2018

Δ

Russia

129,1

160,1

- 24,0 %

125,9

160,1

- 27,2 %

Trinidad & Tobago

136,0

175,4

- 28,9 %

139,8

175,4

- 25,4 %

USA

118,0

136,6

- 15,7 %

124,5

136,6

- 9,7 %

All 3

127,1

153,3

- 20,6 %

128,3

153,3

- 19,5 %

Source: Eurostat.

Source:

| (16) | A number of exporting producers and importers submitted that the significant price increase of the imports from the countries concerned entailed that these imports would not cause negative price effects in the market. These exporting producers also mentioned that there was no stockpiling since initiation. Therefore, it was argued, the remedial effect of the definitive anti-dumping duty, if applied, would not be seriously undermined. |
| --- | --- |

(16)

A number of exporting producers and importers submitted that the significant price increase of the imports from the countries concerned entailed that these imports would not cause negative price effects in the market. These exporting producers also mentioned that there was no stockpiling since initiation. Therefore, it was argued, the remedial effect of the definitive anti-dumping duty, if applied, would not be seriously undermined.

| (17) | The complainant, however, submitted sufficient evidence showing that the price increase was modest as compared to the increase in costs (in particular gas over the summer and autumn in 2018). Moreover, even if there is no conclusive evidence on stockpiling since initiation, the complainant provided further evidence that the steep increase in import volumes since the initiation of the investigation had further aggravated the injurious situation of the Union producers (including increased losses after the investigation period). |
| --- | --- |

(17)

The complainant, however, submitted sufficient evidence showing that the price increase was modest as compared to the increase in costs (in particular gas over the summer and autumn in 2018). Moreover, even if there is no conclusive evidence on stockpiling since initiation, the complainant provided further evidence that the steep increase in import volumes since the initiation of the investigation had further aggravated the injurious situation of the Union producers (including increased losses after the investigation period).

| (18) | On that basis, the Commission established that the evidence on file does not allow the conclusion that this requirement was not met. |
| --- | --- |

(18)

On that basis, the Commission established that the evidence on file does not allow the conclusion that this requirement was not met.

2.4.   Conclusion

Conclusion

| (19) | In light of the above, the Commission found that there is no conclusive evidence showing that the registration of imports of the product concered during the period of the pre-disclosure is not merited in this case. Since the publicacion of the notice of initiation, when exporting producers were aware or should have been aware of the alleged dumping and injury, imports of the product concerned have further increased in a manner which may seriously undermine the remedial effect of the anti-dumping duties also during the pre-disclosure period. |
| --- | --- |

(19)

In light of the above, the Commission found that there is no conclusive evidence showing that the registration of imports of the product concered during the period of the pre-disclosure is not merited in this case. Since the publicacion of the notice of initiation, when exporting producers were aware or should have been aware of the alleged dumping and injury, imports of the product concerned have further increased in a manner which may seriously undermine the remedial effect of the anti-dumping duties also during the pre-disclosure period.

| (20) | The findings remain the same even on the basis of the latest statistical data available to the Commission. |
| --- | --- |

(20)

The findings remain the same even on the basis of the latest statistical data available to the Commission.

| (21) | Thus, in accordance with Article 14(5a) of the basic anti-dumping Regulation, the Commission must register imports of the product concerned during the period of pre-disclosure. |
| --- | --- |

(21)

Thus, in accordance with Article 14(5a) of the basic anti-dumping Regulation, the Commission must register imports of the product concerned during the period of pre-disclosure.

3.   REGISTRATION

REGISTRATION

| (22) | Under Article 14(5a) of the basic anti-dumping Regulation, imports of the product concerned must be made subject to registration during the period of pre-disclosure pursuant Article 19a of the basic Regulation, unless there is sufficient evidence that the requirements of Article 10(4)(c) and (d) are not met. |
| --- | --- |

(22)

Under Article 14(5a) of the basic anti-dumping Regulation, imports of the product concerned must be made subject to registration during the period of pre-disclosure pursuant Article 19a of the basic Regulation, unless there is sufficient evidence that the requirements of Article 10(4)(c) and (d) are not met.

| (23) | Any future liability would emanate from the definitive findings of this anti-dumping investigation. |
| --- | --- |

(23)

Any future liability would emanate from the definitive findings of this anti-dumping investigation.

| (24) | The allegations in the complaint requesting the initiation of the investigation estimate dumping margins from 43 % to 83 % and an average injury elimination level of up to 13 % for the product concerned. The amount of possible future liability is estimated at those levels on the basis of the complaint, namely 13 % to 83 % as a proportion of the CIF import value of the product concerned. |
| --- | --- |

(24)

The allegations in the complaint requesting the initiation of the investigation estimate dumping margins from 43 % to 83 % and an average injury elimination level of up to 13 % for the product concerned. The amount of possible future liability is estimated at those levels on the basis of the complaint, namely 13 % to 83 % as a proportion of the CIF import value of the product concerned.

4.   PROCESSING OF PERSONAL DATA

PROCESSING OF PERSONAL DATA

| (25) | Any personal data collected in the context of this registration will be treated in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (4), |
| --- | --- |

(25)

Any personal data collected in the context of this registration will be treated in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council (4),

4

HAS ADOPTED THIS REGULATION:

Article 1

1.   The customs authorities are hereby directed, under Article 14(5a) of Regulation (EU) 2016/1036, to take the appropriate steps to register imports into the Union of mixtures of urea and ammonium nitrate in aqueous or ammoniacal solution, currently falling within CN code 3102 80 00, and originating in Russia, Trinidad and Tobago and the United States of America.

2.   Registration shall expire three weeks following the date of entry into force of this Regulation.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 March 2019.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  
  OJ L 176, 30.6.2016, p. 21.

1

(2)  
  OJ L 143, 7.6.2018, p. 1.

2

(3)  
  OJ C 284, 13.8.2018, p. 9.

3

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

4

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| 21.3.2019 | EN | Official Journal of the European Union | L 79/13 |
| --- | --- | --- | --- |

21.3.2019

EN

Official Journal of the European Union

L 79/13

---

COMMISSION IMPLEMENTING REGULATION (EU) 2019/456

of 20 March 2019

authorising the change of the specifications of the novel food coriander seed oil from Coriandrum sativum 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) 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 2014/155/EU (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 coriander seed oil from Coriandrum sativum as a novel food ingredient to be used in food supplements. |
| --- | --- |

(4)

Commission Implementing Decision 2014/155/EU (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 coriander seed oil from Coriandrum sativum as a novel food ingredient to be used in food supplements.

| (5) | On 17 May 2018, the company Ovalie Innovation (‘the Applicant’) made a request to the Commission to change the specifications of coriander seed oil from Coriandrum sativum within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to decrease the lower figure of the saponification value from the current 186 mg KOH/g to 179 mg KOH/g. |
| --- | --- |

(5)

On 17 May 2018, the company Ovalie Innovation (‘the Applicant’) made a request to the Commission to change the specifications of coriander seed oil from Coriandrum sativum within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to decrease the lower figure of the saponification value from the current 186 mg KOH/g to 179 mg KOH/g.

| (6) | The applicant justifies the request by indicating that the change is necessary in order to take account of the variation in the saponification values in the course of the production process of the coriander seed oil during its refinement processing for use in food supplements. |
| --- | --- |

(6)

The applicant justifies the request by indicating that the change is necessary in order to take account of the variation in the saponification values in the course of the production process of the coriander seed oil during its refinement processing for use in food supplements.

| (7) | The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary as the proposed decrease in saponification values of the coriander seed oil is limited, while the concomitant increase in unsaponifiable matter, which could be considered of relevance to the safety of the novel food, remains within the authorised limit values. |
| --- | --- |

(7)

The Commission considers that a safety evaluation of the current application by the European Food Safety Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary as the proposed decrease in saponification values of the coriander seed oil is limited, while the concomitant increase in unsaponifiable matter, which could be considered of relevance to the safety of the novel food, remains within the authorised limit values.

| (8) | The proposed change in the saponification values of coriander seed oil from Coriandrum sativum do not alter the safety considerations that supported its authorisation. Therefore, it is appropriate to amend the specifications of the novel food ‘coriander seed oil from Coriandrum sativum’ at the proposed level for saponifiable value. |
| --- | --- |

(8)

The proposed change in the saponification values of coriander seed oil from Coriandrum sativum do not alter the safety considerations that supported its authorisation. Therefore, it is appropriate to amend the specifications of the novel food ‘coriander seed oil from Coriandrum sativum’ at the proposed level for saponifiable value.

| (9) | The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food coriander seed oil from Coriandrum sativum comply with Article 12 of Regulation (EU) 2015/2283. |
| --- | --- |

(9)

The information provided in the application gives sufficient grounds to establish that the proposed changes to the specifications of the novel food coriander seed oil from Coriandrum sativum comply with Article 12 of Regulation (EU) 2015/2283.

| (10) | The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly. |
| --- | --- |

(10)

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

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(11)

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 coriander seed oil from Coriandrum sativum, is 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, 20 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 2014/155/EU of 19 March 2014 authorising the placing on the market of coriander seed oil as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 85, 21.3.2014, p. 13).

3

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

4

---

ANNEX

The entry for ‘Coriander seed oil from Coriandrum sativum
  ’ in Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:

| Authorised Novel Food | Specifications |
| --- | --- |
| ‘Coriander seed oil from

  Coriandrum sativum | Description/Definition:

  Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant Coriandrum sativum L.
  Slight yellow colour, bland taste
  CAS No: 8008-52-4
  Composition of fatty acids: | Palmitic acid (C16:0): 2-5 % |

Authorised Novel Food

Specifications

‘Coriander seed oil from

  Coriandrum sativum

Description/Definition:

Coriander seed oil is an oil containing glycerides of fatty acids that is produced from the seeds of the coriander plant Coriandrum sativum L.

Slight yellow colour, bland taste

CAS No: 8008-52-4

Composition of fatty acids:

Palmitic acid (C16:0): 2-5 %

| | Stearic acid (C18:0): < 1,5 % |
| --- | --- |

Stearic acid (C18:0): < 1,5 %

| | Petroselinic acid (cis-C18:1(n-12)): 60-75 % |
| --- | --- |

Petroselinic acid (cis-C18:1(n-12)): 60-75 %

| | Oleic acid (cis-C18:1 (n-9)): 8-15 % |
| --- | --- |

Oleic acid (cis-C18:1 (n-9)): 8-15 %

| | Linoleic acid (C18:2): 12-19 % |
| --- | --- |

Linoleic acid (C18:2): 12-19 %

| | α-Linolenic acid (C18:3): < 1,0 % |
| --- | --- |

α-Linolenic acid (C18:3): < 1,0 %

| | Trans fatty acids: ≤ 1,0 % |
| --- | --- |

Trans fatty acids: ≤ 1,0 %

Purity:

Refractive index (20 °C): 1,466-1,474

Acid value: ≤ 2,5 mg KOH/g

Peroxide value (PV): ≤ 5,0 meq/kg

Iodine value: 88-110 units

Saponification value: 179-200 mg KOH/g

Unsaponifiable matter: ≤ 15 g/kg’

---

DECISIONS

| 21.3.2019 | EN | Official Journal of the European Union | L 79/16 |
| --- | --- | --- | --- |

21.3.2019

EN

Official Journal of the European Union

L 79/16

---

COUNCIL DECISION (EU) 2019/457

of 19 March 2019

appointing a member, proposed by the Kingdom of Spain, of the Committee of the Regions

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 305 thereof,

Having regard to the proposal of the Spanish Government,

Whereas:

| (1) | On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020. |
| --- | --- |

(1)

On 26 January 2015, 5 February 2015 and 23 June 2015, the Council adopted Decisions (EU) 2015/116 (1), (EU) 2015/190 (2) and (EU) 2015/994 (3) appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020.

| (2) | A member's seat on the Committee of the Regions has become vacant following the end of the term of office of Ms Susana DÍAZ PACHECO, |
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(2)

A member's seat on the Committee of the Regions has become vacant following the end of the term of office of Ms Susana DÍAZ PACHECO,

HAS ADOPTED THIS DECISION:

Article 1

The following is hereby appointed as a member of the Committee of the Regions for the remainder of the current term of office, which runs until 25 January 2020:

| — | Mr Juan Manuel MORENO BONILLA, Presidente de la Junta de Andalucía. |
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—

Mr Juan Manuel MORENO BONILLA, Presidente de la Junta de Andalucía.

Article 2

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

Done at Brussels, 19 March 2019.

For the Council

The President

G. CIAMBA

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(1)  Council Decision (EU) 2015/116 of 26 January 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 20, 27.1.2015, p. 42).

1

(2)  Council Decision (EU) 2015/190 of 5 February 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 31, 7.2.2015, p. 25).

2

(3)  Council Decision (EU) 2015/994 of 23 June 2015 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2015 to 25 January 2020 (OJ L 159, 25.6.2015, p. 70).

3

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| 21.3.2019 | EN | Official Journal of the European Union | L 79/17 |
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21.3.2019

EN

Official Journal of the European Union

L 79/17

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COUNCIL DECISION (EU) 2019/458

of 19 March 2019

amending Decision 1999/70/EC concerning the external auditors of the national central banks, as regards the external auditors of Banque centrale du Luxembourg

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to Protocol No 4 on the Statute of the European System of Central Banks and of the European Central Bank, annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union, and in particular Article 27.1 thereof,

Having regard to the Recommendation of the European Central Bank of 14 February 2019 to the Council of the European Union on the external auditors of Banque centrale du Luxembourg (ECB/2019/6) (1),

Whereas:

| (1) | The accounts of the European Central Bank (ECB) and of the national central banks of the Member States whose currency is the euro are to be audited by independent external auditors recommended by the Governing Council of the ECB and approved by the Council of the European Union. |
| --- | --- |

(1)

The accounts of the European Central Bank (ECB) and of the national central banks of the Member States whose currency is the euro are to be audited by independent external auditors recommended by the Governing Council of the ECB and approved by the Council of the European Union.

| (2) | The mandate of Banque centrale du Luxembourg's current external auditors, Deloitte Audit SARL, expired after the audit for the financial year 2018. It is therefore necessary to appoint external auditors from the financial year 2019. |
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(2)

The mandate of Banque centrale du Luxembourg's current external auditors, Deloitte Audit SARL, expired after the audit for the financial year 2018. It is therefore necessary to appoint external auditors from the financial year 2019.

| (3) | Banque centrale du Luxembourg has selected Ernst & Young SA as its external auditors for the financial years 2019 to 2023. |
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(3)

Banque centrale du Luxembourg has selected Ernst & Young SA as its external auditors for the financial years 2019 to 2023.

| (4) | The Governing Council of the ECB recommended that Ernst & Young SA be appointed as the external auditors of Banque centrale du Luxembourg for the financial years 2019 to 2023. |
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(4)

The Governing Council of the ECB recommended that Ernst & Young SA be appointed as the external auditors of Banque centrale du Luxembourg for the financial years 2019 to 2023.

| (5) | Following the recommendation of the Governing Council of the ECB, Council Decision 1999/70/EC (2) should be amended accordingly, |
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(5)

Following the recommendation of the Governing Council of the ECB, Council Decision 1999/70/EC (2) should be amended accordingly,

HAS ADOPTED THIS DECISION:

Article 1

In Article 1 of Decision 1999/70/EC, paragraph 7 is replaced by the following:

‘7.   Ernst & Young SA are hereby approved as the external auditors of Banque centrale du Luxembourg for the financial years 2019 to 2023.’

Article 2

This Decision shall take effect on the date of its notification.

Article 3

This Decision is addressed to the ECB.

Done at Brussels, 19 March 2019.

For the Council

The President

G. CIAMBA

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(1)  
  OJ C 67, 20.2.2019, p. 1.

1

(2)  Council Decision 1999/70/EC of 25 January 1999 concerning the external auditors of the national central banks (OJ L 22, 29.1.1999, p. 69).

2

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