# Official Journal L 220/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 220 |
| | |
| English edition | Legislation | Volume 5821 August 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 220

English edition

Legislation

Volume 5821 August 2015

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2015/1413 of 10 August 2015 entering a name in the register of protected designations of origin and protected geographical indications (Ogulinski kiseli kupus/Ogulinsko kiselo zelje (PDO)) | 1 |
| | * | Commission Implementing Regulation (EU) 2015/1414 of 20 August 2015 amending Implementing Regulation (EU) No 136/2012 concerning the authorisation of sodium bisulphate as feed additive for pets and for non-food producing animals (
  1
  ) | 3 |
| | * | Commission Implementing Regulation (EU) 2015/1415 of 20 August 2015 concerning the authorisation of astaxanthin as a feed additive for fish, crustaceans and ornamental fish (
  1
  ) | 7 |
| | * | Commission Implementing Regulation (EU) 2015/1416 of 20 August 2015 concerning the authorisation of sodium bisulphate as feed additive for all animal species (
  1
  ) | 11 |
| | * | Commission Implementing Regulation (EU) 2015/1417 of 20 August 2015 concerning the authorisation of diclazuril as a feed additive for rabbits for fattening and for breeding (holder of the authorisation Huvepharma NV) (
  1
  ) | 15 |
| | | Commission Implementing Regulation (EU) 2015/1418 of 20 August 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 18 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2015/1413 of 10 August 2015 entering a name in the register of protected designations of origin and protected geographical indications (Ogulinski kiseli kupus/Ogulinsko kiselo zelje (PDO))

1

*

Commission Implementing Regulation (EU) 2015/1414 of 20 August 2015 amending Implementing Regulation (EU) No 136/2012 concerning the authorisation of sodium bisulphate as feed additive for pets and for non-food producing animals (
  1
  )

1

3

*

Commission Implementing Regulation (EU) 2015/1415 of 20 August 2015 concerning the authorisation of astaxanthin as a feed additive for fish, crustaceans and ornamental fish (
  1
  )

1

7

*

Commission Implementing Regulation (EU) 2015/1416 of 20 August 2015 concerning the authorisation of sodium bisulphate as feed additive for all animal species (
  1
  )

1

11

*

Commission Implementing Regulation (EU) 2015/1417 of 20 August 2015 concerning the authorisation of diclazuril as a feed additive for rabbits for fattening and for breeding (holder of the authorisation Huvepharma NV) (
  1
  )

1

15

Commission Implementing Regulation (EU) 2015/1418 of 20 August 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

18

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Commission Implementing Regulation (EU) 2015/1409 of 19 August 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables ( OJ L 219, 20.8.2015 ) | 20 |

Corrigenda

*

Corrigendum to Commission Implementing Regulation (EU) 2015/1409 of 19 August 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables ( OJ L 219, 20.8.2015 )

( OJ L 219, 20.8.2015 )

20

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

---

II Non-legislative acts

REGULATIONS

| 21.8.2015 | EN | Official Journal of the European Union | L 220/1 |
| --- | --- | --- | --- |

21.8.2015

EN

Official Journal of the European Union

L 220/1

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1413

of 10 August 2015

entering a name in the register of protected designations of origin and protected geographical indications (Ogulinski kiseli kupus/Ogulinsko kiselo zelje (PDO))

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Croatia's application to register the name ‘Ogulinski kiseli kupus’/‘Ogulinsko kiselo zelje’ was published in the Official Journal of the European Union
   (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Croatia's application to register the name ‘Ogulinski kiseli kupus’/‘Ogulinsko kiselo zelje’ was published in the Official Journal of the European Union
   (2).

| (2) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Ogulinski kiseli kupus’/‘Ogulinsko kiselo zelje’ should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Ogulinski kiseli kupus’/‘Ogulinsko kiselo zelje’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Ogulinski kiseli kupus’/‘Ogulinsko kiselo zelje’ (PDO) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.6. Fruit, vegetables and cereals, fresh or processed, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

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, 10 August 2015.

For the Commission,

On behalf of the President,

Phil HOGAN

Member of the Commission

---

(1)  OJ L 343, 14.12.2012, p. 1.

1

(2)  OJ C 115, 10.4.2015, p. 20.

2

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

3

---

| 21.8.2015 | EN | Official Journal of the European Union | L 220/3 |
| --- | --- | --- | --- |

21.8.2015

EN

Official Journal of the European Union

L 220/3

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1414

of 20 August 2015

amending Implementing Regulation (EU) No 136/2012 concerning the authorisation of sodium bisulphate as feed additive for pets and for non-food producing animals

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 13(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or modifying 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 or modifying such authorisation.

| (2) | The use of sodium bisulphate was authorised for 10 years for pets and other non-food producing animals by Commission Implementing Regulation (EU) No 136/2012 (2). |
| --- | --- |

(2)

The use of sodium bisulphate was authorised for 10 years for pets and other non-food producing animals by Commission Implementing Regulation (EU) No 136/2012 (2).

| (3) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted requesting a modification on the conditions of use. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted requesting a modification on the conditions of use. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The application concerns a modification of the conditions of use for pets and other non-food producing animals requesting to modify the content of the additive in the complete feedingstuff. |
| --- | --- |

(4)

The application concerns a modification of the conditions of use for pets and other non-food producing animals requesting to modify the content of the additive in the complete feedingstuff.

| (5) | The European Food Safety Authority concluded in its opinion of 22 May 2014 (3) that, under the proposed conditions of use, the previous content of sodium bisulphate as acidity regulator and as flavouring compound should be modified by new data received. |
| --- | --- |

(5)

The European Food Safety Authority concluded in its opinion of 22 May 2014 (3) that, under the proposed conditions of use, the previous content of sodium bisulphate as acidity regulator and as flavouring compound should be modified by new data received.

| (6) | In order to allow for the use of sodium bisulphate under the new proposed conditions, it is appropriate to amend Implementing Regulation (EU) No 136/2012. |
| --- | --- |

(6)

In order to allow for the use of sodium bisulphate under the new proposed conditions, it is appropriate to amend Implementing Regulation (EU) No 136/2012.

| (7) | The assessment of sodium bisulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annexes to this Regulation. |
| --- | --- |

(7)

The assessment of sodium bisulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annexes to this Regulation.

| (8) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(8)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(9)

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

Annex I to Implementing Regulation (EU) No 136/2012 shall be replaced by the Annex I to this Regulation.

Article 2

Annex II to Implementing Regulation (EU) No 136/2012 shall be replaced by the Annex II to this Regulation.

Article 3

The substance specified in the Annex, and feed containing it, which are produced and labelled before 10 September 2017 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

Article 4

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 August 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Implementing Regulation (EU) No 136/2012 of 16 February 2012 concerning the authorisation of sodium bisulphate as feed additive for pets and other non-food producing animals (OJ L 46, 17.2.2012, p. 33).

2

(3)  EFSA Journal 2014; 12(6):3731.

3

EFSA Journal 2014

---

ANNEX I

‘ANNEX I

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of technological additives. Functional group: acidity regulators |
| 1j514ii | — | Sodium bisulphate | Additive composition

  Sodium bisulphate: ≥ 95,2 %

  Characterisation of the active substance

  Sodium bisulphate CAS No 7681-38-1
  NaHSO4

  Na 19,15 %
  SO4 80,01 %
  Produced by chemical synthesis

  Method of Analysis
   (1)

  Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. | Pets and other non-food producing animals other than cats and mink | — | — | 4 000 | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |

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

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

Category of technological additives. Functional group: acidity regulators

1j514ii

—

Sodium bisulphate

Additive composition

Sodium bisulphate: ≥ 95,2 %

Characterisation of the active substance

Sodium bisulphate CAS No 7681-38-1

NaHSO4

Na 19,15 %

SO4 80,01 %

Produced by chemical synthesis

Method of Analysis
   (1)

Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.

Pets and other non-food producing animals other than cats and mink

—

—

4 000

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | For safety: breathing protection, eye protection and gloves shall be used during handling. |
| --- | --- |

2.

For safety: breathing protection, eye protection and gloves shall be used during handling.

| 3. | The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species |
| --- | --- |

3.

The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species

8 March 2022

Cats

20 000

Mink

10 000

---

(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’

1

---

ANNEX II

‘ANNEX II

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of sensory additives. Functional group: flavouring compounds |
| 1j514ii | — | Sodium bisulphate | Additive composition

  Sodium bisulphate: ≥ 95,2 %

  Characterisation of the active substance

  Sodium bisulphate CAS No 7681-38-1
  NaHSO4

  Na 19,15 %
  SO4 80,01 %
  Produced by chemical synthesis

  Method of Analysis
   (1)

  Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. | Pets and other non-food producing animals other than cats and mink | — | — | 4 000 | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |

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

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

Category of sensory additives. Functional group: flavouring compounds

1j514ii

—

Sodium bisulphate

Additive composition

Sodium bisulphate: ≥ 95,2 %

Characterisation of the active substance

Sodium bisulphate CAS No 7681-38-1

NaHSO4

Na 19,15 %

SO4 80,01 %

Produced by chemical synthesis

Method of Analysis
   (1)

Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.

Pets and other non-food producing animals other than cats and mink

—

—

4 000

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | For safety: breathing protection, eye protection and gloves shall be used during handling. |
| --- | --- |

2.

For safety: breathing protection, eye protection and gloves shall be used during handling.

| 3. | The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. |
| --- | --- |

3.

The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.

8 March 2022

Cats

20 000

Mink

10 000

---

(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’

1

---

| 21.8.2015 | EN | Official Journal of the European Union | L 220/7 |
| --- | --- | --- | --- |

21.8.2015

EN

Official Journal of the European Union

L 220/7

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1415

of 20 August 2015

concerning the authorisation of astaxanthin as a feed additive for fish, crustaceans and ornamental fish

(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 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
| --- | --- |

(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 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | Astaxanthin was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for salmon, trout and ornamental fish. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

Astaxanthin was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for salmon, trout and ornamental fish. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, two applications were submitted for the re-evaluation of astaxanthin and its preparations as a sensory additive for salmon, trout and ornamental fish, and, in accordance with Article 7 of that Regulation, for a new use for crustaceans and for fish other than salmon and trout. The applicants requested this additive to be classified in the additive category ‘sensory additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, two applications were submitted for the re-evaluation of astaxanthin and its preparations as a sensory additive for salmon, trout and ornamental fish, and, in accordance with Article 7 of that Regulation, for a new use for crustaceans and for fish other than salmon and trout. The applicants requested this additive to be classified in the additive category ‘sensory additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 20 May 2014 (3) that, under the proposed conditions of use in feed, astaxanthin does not have an adverse effects on animal health, human health or the environment. The Authority also concluded that astaxanthin is efficacious in colouring the flesh of fish, the epidermis of crustaceans and the skin of ornamental fish. It further concluded that no safety concerns would arise for users. 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 additives 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 opinions of 20 May 2014 (3) that, under the proposed conditions of use in feed, astaxanthin does not have an adverse effects on animal health, human health or the environment. The Authority also concluded that astaxanthin is efficacious in colouring the flesh of fish, the epidermis of crustaceans and the skin of ornamental fish. It further concluded that no safety concerns would arise for users. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (5) | The assessment of astaxanthin shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation. Maximum contents should be set up for astaxanthin. |
| --- | --- |

(5)

The assessment of astaxanthin shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation. Maximum contents should be set up for astaxanthin.

| (6) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(6)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (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 substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’ is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 10 March 2016 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 10 September 2016 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for fish.

3.   Compound feed and feed materials containing the substance specified in the Annex which are produced and labelled before 10 September 2017 in accordance with the rules applicable before 10 September 2015 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for ornamental fish.

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, 20 August 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  EFSA Journal 2014; 12(6):3724 and EFSA Journal 2014; 12(6):3725.

3

---

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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of active substance of complete feedingstuff with a moisture content of 12 % |
| Category of sensory additives. Functional group: a. colourants (ii) substances which, when fed to animals, add colours to food of animal origin |
| 2a161j | — | Astaxanthin | Additive composition

  Astaxanthin
  Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg
  Dichloromethane ≤ 600 mg/kg

  Characterisation of the active substance

  Astaxanthin
  C40H52O4

  CAS No: 7542-45-2
  Astaxanthin, solid form, produced by chemical synthesis
  Purity criteria:






  — | Assay (expressed as astaxanthin): min 96 % of total colouring matters. |

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

mg/kg of active substance of complete feedingstuff with a moisture content of 12 %

Category of sensory additives. Functional group: a. colourants (ii) substances which, when fed to animals, add colours to food of animal origin

2a161j

—

Astaxanthin

Additive composition

Astaxanthin

Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg

Dichloromethane ≤ 600 mg/kg

Characterisation of the active substance

Astaxanthin

C40H52O4

CAS No: 7542-45-2

Astaxanthin, solid form, produced by chemical synthesis

Purity criteria:

—

Assay (expressed as astaxanthin): min 96 % of total colouring matters.

| — | Carotenoids other than astaxanthin: max 5 % of total colouring matters. |
| --- | --- |

—

Carotenoids other than astaxanthin: max 5 % of total colouring matters.

Method of Analysis
   (1)

| — | For the quantification of Astaxanthin in the feed additive preparation: spectrophotometry at 431 nm. |
| --- | --- |

—

For the quantification of Astaxanthin in the feed additive preparation: spectrophotometry at 431 nm.

| — | For the quantification of Astaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 470 nm). |
| --- | --- |

—

For the quantification of Astaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 470 nm).

Fish

—

—

100

| 1. | Astaxanthin may be placed on the market and used as an additive consisting of a preparation. |
| --- | --- |

1.

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

| 2. | In the directions for use of the additive and premixtures, indicate the stability and storage conditions. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, indicate the stability and storage conditions.

| 3. | The mixture of astaxanthin with other carotenoids and xanthophylls shall not exceed 100 mg/kg of complete feed (moisture content 12 %). |
| --- | --- |

3.

The mixture of astaxanthin with other carotenoids and xanthophylls shall not exceed 100 mg/kg of complete feed (moisture content 12 %).

| 4. | For safety: breathing protection, safety glasses and gloves shall be worn during handling. |
| --- | --- |

4.

For safety: breathing protection, safety glasses and gloves shall be worn during handling.

10 September 2025

Crustaceans

—

—

100

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of active substance of complete feedingstuff with a moisture content of 12 % |
| Category of sensory additives. Functional group: a. colourants (iii) substances which favourably affect the colour of ornamental fish or birds |
| 2a161j | — | Astaxanthin | Additive composition

  Astaxanthin
  Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg
  Dichloromethane ≤ 600 mg/kg

  Characterisation of the active substance

  Astaxanthin
  C40H52O4

  CAS No: 7542-45-2
  Astaxanthin, solid form, produced by chemical synthesis
  Purity criteria:






  — | Assay (expressed as astaxanthin): min 96 % of total colouring matters. |

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

mg/kg of active substance of complete feedingstuff with a moisture content of 12 %

Category of sensory additives. Functional group: a. colourants (iii) substances which favourably affect the colour of ornamental fish or birds

2a161j

—

Astaxanthin

Additive composition

Astaxanthin

Triphenylphosphine oxide (TPPO) ≤ 100 mg/kg

Dichloromethane ≤ 600 mg/kg

Characterisation of the active substance

Astaxanthin

C40H52O4

CAS No: 7542-45-2

Astaxanthin, solid form, produced by chemical synthesis

Purity criteria:

—

Assay (expressed as astaxanthin): min 96 % of total colouring matters.

| — | Carotenoids other than astaxanthin: max 5 % of total colouring matters. |
| --- | --- |

—

Carotenoids other than astaxanthin: max 5 % of total colouring matters.

Method of Analysis
   (2)

| — | For the quantification of Astaxanthin in the feed additive preparation: spectrophotometry at 431 nm. |
| --- | --- |

—

For the quantification of Astaxanthin in the feed additive preparation: spectrophotometry at 431 nm.

| — | For the quantification of Astaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 470 nm). |
| --- | --- |

—

For the quantification of Astaxanthin in the premixtures and feedingstuffs: Normal Phase High Performance Liquid Chromatography coupled to visible detection (NP-HPLC-VIS, 470 nm).

Ornamental fish

—

—

100

| 1. | Astaxanthin may be placed on the market and used as an additive consisting of a preparation. |
| --- | --- |

1.

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

| 2. | In the directions for use of the additive and premixtures, indicate the stability and storage conditions. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, indicate the stability and storage conditions.

| 3. | The mixture of astaxanthin with other carotenoids and xanthophylls shall not exceed 100 mg/kg of complete feed (moisture content 12 %). |
| --- | --- |

3.

The mixture of astaxanthin with other carotenoids and xanthophylls shall not exceed 100 mg/kg of complete feed (moisture content 12 %).

| 4. | For safety: breathing protection, safety glasses and gloves shall be worn during handling. |
| --- | --- |

4.

For safety: breathing protection, safety glasses and gloves shall be worn during handling.

10 September 2025

---

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

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

---

| 21.8.2015 | EN | Official Journal of the European Union | L 220/11 |
| --- | --- | --- | --- |

21.8.2015

EN

Official Journal of the European Union

L 220/11

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1416

of 20 August 2015

concerning the authorisation of sodium bisulphate as feed additive 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. |
| --- | --- |

(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) | The use of sodium bisulphate was authorised for 10 years for pets and other non-food producing animals by Commission Implementing Regulation (EU) No 136/2012 (2). |
| --- | --- |

(2)

The use of sodium bisulphate was authorised for 10 years for pets and other non-food producing animals by Commission Implementing Regulation (EU) No 136/2012 (2).

| (3) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of sodium bisulphate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of sodium bisulphate. That 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 sodium bisulphate as a feed additive for all animal species, to be classified in the additive categories ‘technological additives’. |
| --- | --- |

(4)

The application concerns the authorisation of sodium bisulphate as a feed additive for all animal species, to be classified in the additive categories ‘technological additives’.

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 11 October 2011 (3) and of 22 May 2014 (4) that, under the proposed conditions of use, sodium bisulphate does not have an adverse effect on animal health, human health or the environment, and that its use is considered efficacious as preservative and acidity regulator for all animal species. The Authority does not consider that there is a need for specific requirement 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 opinions of 11 October 2011 (3) and of 22 May 2014 (4) that, under the proposed conditions of use, sodium bisulphate does not have an adverse effect on animal health, human health or the environment, and that its use is considered efficacious as preservative and acidity regulator for all animal species. The Authority does not consider that there is a need for specific requirement 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 sodium bisulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annexes to this Regulation. |
| --- | --- |

(6)

The assessment of sodium bisulphate shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annexes 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 substance specified in Annex I, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

The substance specified in Annex II, belonging to the additive category ‘technological additives’ and to the functional group ‘acidity regulators’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

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, 20 August 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Implementing Regulation (EU) No 136/2012 of 16 February 2012 concerning the authorisation of sodium bisulphate as feed additive for pets and other non-food producing animals (OJ L 46, 17.2.2012, p. 33).

2

(3)  EFSA Journal 2011; 9(11):2415.

3

EFSA Journal 2011

(4)  EFSA Journal 2014; 12(6):3731.

4

EFSA Journal 2014

---

ANNEX I

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of technological additives. Functional group: preservatives |
| 1j514ii | — | Sodium bisulphate | Additive composition

  Sodium bisulphate: ≥ 95,2 %

  Characterisation of the active substance

  Sodium bisulphate CAS No 7681-38-1
  NaHSO4

  Na 19,15 %
  SO4 80,01 %
  Produced by chemical synthesis

  Method of Analysis
   (1)

  Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. | All animal species other than cats and mink | — | — | 4 000 | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |

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

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

Category of technological additives. Functional group: preservatives

1j514ii

—

Sodium bisulphate

Additive composition

Sodium bisulphate: ≥ 95,2 %

Characterisation of the active substance

Sodium bisulphate CAS No 7681-38-1

NaHSO4

Na 19,15 %

SO4 80,01 %

Produced by chemical synthesis

Method of Analysis
   (1)

Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.

All animal species other than cats and mink

—

—

4 000

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | For safety: breathing protection, eye protection and gloves shall be used during handling. |
| --- | --- |

2.

For safety: breathing protection, eye protection and gloves shall be used during handling.

| 3. | The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. |
| --- | --- |

3.

The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.

10 September 2025

Cats

20 000

Mink

10 000

---

(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

---

ANNEX II

| 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 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg/kg of complete feedingstuff with a moisture content of 12 % |
| Category of technological additives. Functional group: acidity regulators |
| 1j514ii | — | Sodium bisulphate | Additive composition

  Sodium bisulphate: ≥ 95,2 %

  Characterisation of the active substance

  Sodium bisulphate CAS No 7681-38-1
  NaHSO4

  Na 19,15 %
  SO4 80,01 %
  Produced by chemical synthesis

  Method of Analysis
   (1)

  Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution. | All animal species other than cats, mink, pet and other non-food producing animals | — | — | 4 000 | 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |

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

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

Category of technological additives. Functional group: acidity regulators

1j514ii

—

Sodium bisulphate

Additive composition

Sodium bisulphate: ≥ 95,2 %

Characterisation of the active substance

Sodium bisulphate CAS No 7681-38-1

NaHSO4

Na 19,15 %

SO4 80,01 %

Produced by chemical synthesis

Method of Analysis
   (1)

Determination of sodium hydrogen sulphate in feed additives: titrimetric method based on the determination of total soluble acidity of sodium bisulphate against a standard sodium hydroxide solution.

All animal species other than cats, mink, pet and other non-food producing animals

—

—

4 000

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | For safety: breathing protection, eye protection and gloves shall be used during handling. |
| --- | --- |

2.

For safety: breathing protection, eye protection and gloves shall be used during handling.

| 3. | The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species. |
| --- | --- |

3.

The total content of sodium bisulphate must not exceed the maximum permitted levels in complete feedingstuff established for each relevant species.

10 September 2025

---

(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

---

| 21.8.2015 | EN | Official Journal of the European Union | L 220/15 |
| --- | --- | --- | --- |

21.8.2015

EN

Official Journal of the European Union

L 220/15

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1417

of 20 August 2015

concerning the authorisation of diclazuril as a feed additive for rabbits for fattening and for breeding (holder of the authorisation Huvepharma NV)

(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 diclazuril. 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 diclazuril. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | That application concerns the authorisation of diclazuril, CAS number 101831-37-2, as a feed additive for rabbits for fattening and for breeding, to be classified in the additive category ‘coccidiostats and histomonostas’. |
| --- | --- |

(3)

That application concerns the authorisation of diclazuril, CAS number 101831-37-2, as a feed additive for rabbits for fattening and for breeding, to be classified in the additive category ‘coccidiostats and histomonostas’.

| (4) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 10 December 2014 (2) that, under the proposed conditions of use, diclazuril does not have an adverse effect on animal health, human health or the environment and is effective in controlling coccidiosis in rabbits for fattening and for breeding. It considers that there is a need for specific requirements of post-market monitoring to verify the resistance to Eimeria spp. The Authority 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. |
| --- | --- |

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 10 December 2014 (2) that, under the proposed conditions of use, diclazuril does not have an adverse effect on animal health, human health or the environment and is effective in controlling coccidiosis in rabbits for fattening and for breeding. It considers that there is a need for specific requirements of post-market monitoring to verify the resistance to Eimeria spp. The Authority 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 assessment of diclazuril, CAS number 101831-37-2, shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation. |
| --- | --- |

(5)

The assessment of diclazuril, CAS number 101831-37-2, shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation 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

Authorisation

The preparation specified in the Annex belonging to the additive category ‘coccidiostats and histomonostas’, 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, 20 August 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  EFSA Journal 2015; 13(1):3968.

2

EFSA Journal

---

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 | Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feeding stuff with a moisture content of 12 % |
| Coccidiostats and histomonostats |
| 51775 | Huvepharma NV | Diclazuril 0,5 g/100 g (Coxiril) | Additive composition

  Preparation of: | Diclazuril: 5 g/kg. |

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

Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin

mg of active substance/kg of complete feeding stuff with a moisture content of 12 %

Coccidiostats and histomonostats

51775

Huvepharma NV

Diclazuril 0,5 g/100 g (Coxiril)

Additive composition

Preparation of:

Diclazuril: 5 g/kg.

| | Starch: 15 g/kg. |
| --- | --- |

Starch: 15 g/kg.

| | Wheat meal: 700 g/kg. |
| --- | --- |

Wheat meal: 700 g/kg.

| | Calcium carbonate: 280 g/kg. |
| --- | --- |

Calcium carbonate: 280 g/kg.

Characterisation of the active substance

Diclazuril, C17H9Cl3N4O2, (±)-4-chlorophenyl[2,6-dichloro-4- (2,3,4,5- tetrahydro-3,5-dioxo-1,2,4-triazin-2- yl)phenyl]acetonitrile,

CAS number: 101831-37-2.

Impurity D (1): ≤ 0,1 %.

Any other single impurity: ≤ 0,5 %.

Total impurities: ≤ 1,5 %.

Analytical method
   (2)

For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280nm (Commission Regulation (EC) No 152/2009 (3)).

Rabbits

—

1

1

| 1. | The additive shall be incorporated in compound feed in the form of a premixture. |
| --- | --- |

1.

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

| 2. | Diclazuril shall not be mixed with other coccidiostats. |
| --- | --- |

2.

Diclazuril shall not be mixed with other coccidiostats.

| 3. | For safety: breathing protection, glasses and gloves shall be used during handling. |
| --- | --- |

3.

For safety: breathing protection, glasses and gloves shall be used during handling.

| 4. | Use prohibited at least two days before slaughter. |
| --- | --- |

4.

Use prohibited at least two days before slaughter.

| 5. | A post market monitoring programme concerning the resistance to Eimeria spp. shall be carried out by the holder of authorisation during the latter part of the period of the authorisation. |
| --- | --- |

5.

A post market monitoring programme concerning the resistance to Eimeria spp. shall be carried out by the holder of authorisation during the latter part of the period of the authorisation.

10 September 2025

Commission Regulation (EU) No 37/2010 (4)

| (— | 2 500 μg diclazuril/kg of wet liver. |
| --- | --- |

(—

2 500 μg diclazuril/kg of wet liver.

| — | 1 000 μg diclazuril/kg of wet kidney. |
| --- | --- |

—

1 000 μg diclazuril/kg of wet kidney.

| — | 150 μg diclazuril/kg of wet muscle. |
| --- | --- |

—

150 μg diclazuril/kg of wet muscle.

| — | 300 μg diclazuril/kg of wet skin/fat.) |
| --- | --- |

—

300 μg diclazuril/kg of wet skin/fat.)

---

(1)  European Pharmacopoeia monograph 1718 (Diclazuril for Veterinary use).

(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)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).

(4)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

---

| 21.8.2015 | EN | Official Journal of the European Union | L 220/18 |
| --- | --- | --- | --- |

21.8.2015

EN

Official Journal of the European Union

L 220/18

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/1418

of 20 August 2015

establishing the standard import values for determining the entry price of certain fruit and vegetables

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),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

| (1) | Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
| --- | --- |

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

| (2) | The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
| --- | --- |

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day 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 August 2015.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

---

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

1

(2)  OJ L 157, 15.6.2011, p. 1.

2

---

ANNEX

Standard import values for determining the entry price of certain fruit and vegetables

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | MA | 156,5 |
| ZZ | 156,5 |
| 0709 93 10 | TR | 124,7 |
| ZZ | 124,7 |
| 0805 50 10 | AR | 126,2 |
| BO | 154,5 |
| CL | 153,9 |
| UY | 144,0 |
| ZA | 149,9 |
| ZZ | 145,7 |
| 0806 10 10 | EG | 238,9 |
| TR | 167,5 |
| US | 339,9 |
| ZZ | 248,8 |
| 0808 10 80 | AR | 234,3 |
| BR | 97,6 |
| CL | 147,4 |
| NZ | 152,0 |
| US | 110,0 |
| UY | 141,9 |
| ZA | 122,1 |
| ZZ | 143,6 |
| 0808 30 90 | AR | 155,3 |
| CL | 135,1 |
| CN | 85,3 |
| NZ | 109,3 |
| TR | 132,9 |
| ZA | 119,6 |
| ZZ | 122,9 |
| 0809 30 10, 0809 30 90 | MK | 79,3 |
| TR | 126,3 |
| ZZ | 102,8 |
| 0809 40 05 | BA | 42,6 |
| IL | 99,6 |
| MK | 36,8 |
| XS | 57,7 |
| ZZ | 59,2 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

156,5

ZZ

156,5

0709 93 10

TR

124,7

ZZ

124,7

0805 50 10

AR

126,2

BO

154,5

CL

153,9

UY

144,0

ZA

149,9

ZZ

145,7

0806 10 10

EG

238,9

TR

167,5

US

339,9

ZZ

248,8

0808 10 80

AR

234,3

BR

97,6

CL

147,4

NZ

152,0

US

110,0

UY

141,9

ZA

122,1

ZZ

143,6

0808 30 90

AR

155,3

CL

135,1

CN

85,3

NZ

109,3

TR

132,9

ZA

119,6

ZZ

122,9

0809 30 10, 0809 30 90

MK

79,3

TR

126,3

ZZ

102,8

0809 40 05

BA

42,6

IL

99,6

MK

36,8

XS

57,7

ZZ

59,2

---

(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

---

Corrigenda

| 21.8.2015 | EN | Official Journal of the European Union | L 220/20 |
| --- | --- | --- | --- |

21.8.2015

EN

Official Journal of the European Union

L 220/20

---

Corrigendum to Commission Implementing Regulation (EU) 2015/1409 of 19 August 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

(
  Official Journal of the European Union L 219 of 20 August 2015
  )

On page 7, in the Annex:

for:

| ‘EG | 253,2’, |
| --- | --- |

‘EG

253,2’,

read:

| ‘EG | 235,2’. |
| --- | --- |

‘EG

235,2’.

---