# L_2013192EN.01003501.xml

| 13.7.2013 | EN | Official Journal of the European Union | L 192/35 |
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13.7.2013

EN

Official Journal of the European Union

L 192/35

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COMMISSION IMPLEMENTING REGULATION (EU) No 667/2013

of 12 July 2013

concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of authorisation Eli Lilly and Company Ltd) and repealing Regulation (EC) No 162/2003

(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). |
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(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) | Diclazuril, CAS number 101831-37-2, was authorised for 10 years in accordance with Directive 70/524/EEC as a feed additive for use on chickens reared for laying by Commission Regulation (EC) No 162/2003 (3). That preparation 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. |
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(2)

Diclazuril, CAS number 101831-37-2, was authorised for 10 years in accordance with Directive 70/524/EEC as a feed additive for use on chickens reared for laying by Commission Regulation (EC) No 162/2003 (3). That preparation 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, an application was submitted for the re-evaluation of diclazuril, as a feed additive for chickens reared for laying, requesting that additive to be classified in the additive category ‘coccidiostats and histomonostats’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
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(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 re-evaluation of diclazuril, as a feed additive for chickens reared for laying, requesting that additive to be classified in the additive category ‘coccidiostats and histomonostats’. That application was 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 opinion of 31 January 2013 (4) that, under the proposed conditions of use in feed, diclazuril does not have an adverse effect on animal, human health or the environment and it is effective in controlling coccidiosis in chickens reared for laying. 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. |
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(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 31 January 2013 (4) that, under the proposed conditions of use in feed, diclazuril does not have an adverse effect on animal, human health or the environment and it is effective in controlling coccidiosis in chickens reared for laying. 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 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. |
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(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) | As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 162/2003 should be repealed. |
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(6)

As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulation (EC) No 162/2003 should be repealed.

| (7) | 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. |
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(7)

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) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’ is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Regulation (EC) No 162/2003 is repealed.

Article 3

The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 2 February 2014 in accordance with the rules applicable before 2 August 2013 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, 12 July 2013.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  OJ L 270, 14.12.1970, p. 1.

2

(3)  
  OJ L 26, 31.1.2003, p. 3.

3

(4)  
  EFSA Journal 2013; 11(3):3106.

4

EFSA Journal

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ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive
  (Trade name) | 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 |
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| mg of active substance/kg of complete feedingstuff with a moisture content of 12 % |
| Coccidiostats and histomonostats |
| 51771 | Eli Lilly and Company Ltd | Diclazuril 0,5 g/100 g
  (Clinacox 0,5 %) | | Additive composition | Diclazuril: 0,50 g/100 g |

Identification number of the additive

Name of the holder of authorisation

Additive

(Trade name)

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 feedingstuff with a moisture content of 12 %

Coccidiostats and histomonostats

51771

Eli Lilly and Company Ltd

Diclazuril 0,5 g/100 g

(Clinacox 0,5 %)

Additive composition

Diclazuril: 0,50 g/100 g

| | Protein-poor soybean meal: 99,25 g/100 g |
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Protein-poor soybean meal: 99,25 g/100 g

| | Polyvidone K 30: 0,20 g/100 g |
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Polyvidone K 30: 0,20 g/100 g

| | Sodium hydroxide: 0,05 g/100 g |
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Sodium hydroxide: 0,05 g/100 g

| | 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, |
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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 |
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CAS number: 101831-37-2

| | Related impurities: | Degradation compound (R064318): ≤ 0,1 % |
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Related impurities:

Degradation compound (R064318): ≤ 0,1 %

| | Other related impurities (T001434, R066891, R068610, R070156, R070016): ≤ 0,5 % individually |
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Other related impurities (T001434, R066891, R068610, R070156, R070016): ≤ 0,5 % individually

| | Total impurities: ≤ 1,5 % |
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Total impurities: ≤ 1,5 %

| | Analytical method
   (1) | For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Commission Regulation (EC) No 152/2009 (2)). |
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Analytical method
   (1)

For determination of diclazuril in feed: reversed-phase high performance liquid chromatography (HPLC) using Ultraviolet detection at 280 nm (Commission Regulation (EC) No 152/2009 (2)).

| | For determination of diclazuril in poultry tissues: HPLC coupled to triple quadrupole mass spectrometer (MS/MS) using one precursor ion and two diagnostic product ions. |
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For determination of diclazuril in poultry tissues: HPLC coupled to triple quadrupole mass spectrometer (MS/MS) using one precursor ion and two diagnostic product ions.

Chickens reared for laying

16 weeks

1

1

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

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

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

Diclazuril shall not be mixed with other coccidiostats.

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

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

| 4. | A post-market monitoring programme concerning the resistance to bacteria and Eimeria spp. shall be carried out by the holder of authorisation. |
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4.

A post-market monitoring programme concerning the resistance to bacteria and Eimeria spp. shall be carried out by the holder of authorisation.

2 August 2023

Commission Regulation (EU) No 37/2010 (3)

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(1)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

(2)  
  OJ L 54, 26.2.2009, p. 1.

(3)  
  OJ L 15, 20.1.2010, p. 1.

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