# Official Journal L 395/2020

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 395 |
| | |
| English edition | Legislation | Volume 6325 November 2020 |

ISSN 1977-0677

Official Journal

of the European Union

L 395

English edition

Legislation

Volume 6325 November 2020

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Information on the date of signature and provisional application of the Agreement in the form of an Exchange of Letters between the European Union and the Government of the Cook Islands concerning an extension to the Protocol on the implementation of the Sustainable Fisheries Partnership Agreement between the European Union and the Government of the Cook Islands | 1 |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2020/1753 of 18 November 2020 approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication Ribeiro (PDO) | 2 |
| | * | Commission Regulation (EU) 2020/1754 of 19 November 2020 establishing a fisheries closure for bigeye tuna in the Atlantic Ocean for vessels flying the flag of Portugal | 3 |
| | * | Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH) (
  1
  ) | 5 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Information on the date of signature and provisional application of the Agreement in the form of an Exchange of Letters between the European Union and the Government of the Cook Islands concerning an extension to the Protocol on the implementation of the Sustainable Fisheries Partnership Agreement between the European Union and the Government of the Cook Islands

1

REGULATIONS

*

Commission Implementing Regulation (EU) 2020/1753 of 18 November 2020 approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication Ribeiro (PDO)

2

*

Commission Regulation (EU) 2020/1754 of 19 November 2020 establishing a fisheries closure for bigeye tuna in the Atlantic Ocean for vessels flying the flag of Portugal

3

*

Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH) (
  1
  )

Bacillus coagulans

1

5

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| | (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

| 25.11.2020 | EN | Official Journal of the European Union | L 395/1 |
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25.11.2020

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Official Journal of the European Union

L 395/1

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Information on the date of signature and provisional application of the Agreement in the form of an Exchange of Letters between the European Union and the Government of the Cook Islands concerning an extension to the Protocol on the implementation of the Sustainable Fisheries Partnership Agreement between the European Union and the Government of the Cook Islands

The European Union and the Government of the Cook Islands signed on 13 November 2020, in Brussels, the Agreement in the form of an Exchange of Letters between the European Union and the Government of the Cook Islands concerning an extension to the Protocol on the implementation of the Sustainable Fisheries Partnership Agreement between the European Union and the Government of the Cook Islands.

The Agreement accordingly applies provisionally from 14 November 2020 pursuant to point 6 thereof, for a maximum period of one year.

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REGULATIONS

| 25.11.2020 | EN | Official Journal of the European Union | L 395/2 |
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25.11.2020

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Official Journal of the European Union

L 395/2

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1753

of 18 November 2020

approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication ‘Ribeiro’ (PDO)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,

Whereas:

| (1) | The Commission has examined the application for the approval of amendments to the specification for the Protected Designation of Origin ‘Ribeiro’, forwarded by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013. |
| --- | --- |

(1)

The Commission has examined the application for the approval of amendments to the specification for the Protected Designation of Origin ‘Ribeiro’, forwarded by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.

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

(2)

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

| (3) | No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013. |
| --- | --- |

(3)

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

| (4) | The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013. |
| --- | --- |

(4)

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

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets, |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Ribeiro’ (PDO) are hereby approved.

Article 2

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

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

Done at Brussels, 18 November 2020.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

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

1

(2)  
  OJ C 196, 11.6.2020, p. 33.

2

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| 25.11.2020 | EN | Official Journal of the European Union | L 395/3 |
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25.11.2020

EN

Official Journal of the European Union

L 395/3

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COMMISSION REGULATION (EU) 2020/1754

of 19 November 2020

establishing a fisheries closure for bigeye tuna in the Atlantic Ocean for vessels flying the flag of Portugal

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

| (1) | Council Regulation (EU) 2020/123 (2) lays down quotas for 2020. |
| --- | --- |

(1)

Council Regulation (EU) 2020/123 (2) lays down quotas for 2020.

| (2) | According to the information received by the Commission, catches of the stock of bigeye tuna in the Atlantic Ocean by vessels flying the flag of or registered in Portugal have exhausted the quota allocated for 2020. |
| --- | --- |

(2)

According to the information received by the Commission, catches of the stock of bigeye tuna in the Atlantic Ocean by vessels flying the flag of or registered in Portugal have exhausted the quota allocated for 2020.

| (3) | It is therefore necessary to prohibit certain fishing activities for that stock, |
| --- | --- |

(3)

It is therefore necessary to prohibit certain fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to Portugal for the stock of bigeye tuna in the Atlantic Ocean for 2020 referred to in the Annex shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in Article 1 by vessels flying the flag of or registered in Portugal shall be prohibited from the date set out in the Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 19 November 2020.

For the Commission,

On behalf of the President,

Virginijus SINKEVIČIUS

Member of the Commission

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(1)  
  OJ L 343, 22.12.2009, p. 1.

1

(2)  Council Regulation (EU) 2020/123 of 27 January 2020 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters (OJ L 25, 30.1.2020, p. 1).

2

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ANNEX

| No | 30/TQ/123 |
| --- | --- |
| Member State | Portugal |
| Stock | BET/ATLANT |
| Species | Bigeye tuna (Thunnus obesus) including special condition BET/*ATLLL and BET/*ATLPS |
| Zone | Atlantic Ocean |
| Closing date | 27.10.2020 |

No

30/TQ/123

Member State

Portugal

Stock

BET/ATLANT

Species

Bigeye tuna (Thunnus obesus) including special condition BET/*ATLLL and BET/*ATLPS

Zone

Atlantic Ocean

Closing date

27.10.2020

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| 25.11.2020 | EN | Official Journal of the European Union | L 395/5 |
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25.11.2020

EN

Official Journal of the European Union

L 395/5

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/1755

of 24 November 2020

concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH)

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

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of Bacillus coagulans DSM 32016. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of Bacillus coagulans DSM 32016. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns the authorisation of the preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds, to be classified in the category ‘zootechnical additives’. |
| --- | --- |

(3)

The application concerns the authorisation of the preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds, to be classified in the category ‘zootechnical additives’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 May 2020 (2) that, under the proposed conditions of use, the preparation of Bacillus coagulans DSM 32016 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the preparation has the potential to be efficacious as zootechnical additive in feedingstuffs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 May 2020 (2) that, under the proposed conditions of use, the preparation of Bacillus coagulans DSM 32016 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the preparation has the potential to be efficacious as zootechnical additive in feedingstuffs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of the preparation of Bacillus coagulans DSM 32016 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the product should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment of the preparation of Bacillus coagulans DSM 32016 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the product should be authorised as specified in the Annex to this Regulation.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(6)

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

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

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

Done at Brussels, 24 November 2020.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  
  EFSA Journal 2020;18(6):6158.

2

EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| CFU/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: gut flora stabilisers |
| 4b1900 | Biochem Zusatzstoffe Handels- und Produktionsges. mbH | Bacillus coagulans DSM 32016 | Additive composition

  Preparation of Bacillus coagulans DSM 32016 containing a minimum of 2 × 1010 CFU/g additive
  Solid form | Suckling and weaned Suidae piglets | - | 1 × 109 | - | 1. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

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

Category of zootechnical additives. Functional group: gut flora stabilisers

4b1900

Biochem Zusatzstoffe Handels- und Produktionsges. mbH

Bacillus coagulans DSM 32016

Additive composition

Preparation of Bacillus coagulans DSM 32016 containing a minimum of 2 × 1010 CFU/g additive

Solid form

Suckling and weaned Suidae piglets

-

1 × 109

-

1.

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

| 2. | May be used in feed containing the following permitted coccidiostats: halofuginone and diclazuril. |
| --- | --- |

2.

May be used in feed containing the following permitted coccidiostats: halofuginone and diclazuril.

| 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.

15.12.2030

Characterisation of the active substance

Viable spores of cells of Bacillus coagulans DSM 32016

Poultry for fattening

Analytical method
   (1)

Enumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on MRS agar (based on EN 15787 method).

Identification: Pulsed Field Gel Electrophoresis (PFGE).

Ornamental birds

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

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