Commission Regulation (EC) No 976/2008 of 6 October 2008 amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of the feed additive Clinacox , belonging to the group of coccidiostats and other medicinal substances (Text with EEA relevance)
Commission Regulation (EC) No 976/2008of 6 October 2008amending Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 as regards the terms of the authorisation of the feed additive Clinacox, belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,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 nutritionOJ L 268, 18.10.2003, p. 29., and in particular Article 13(3) thereof,Whereas:(1)The additive diclazuril (Clinacox 0,5 % Premix), belonging to the group of coccidiostats and other medicinal substances, was authorised under certain conditions in accordance with Council Directive 70/524/EECOJ L 270, 14.12.1970, p. 1.. Commission Regulations (EC) No 2430/1999OJ L 296, 17.11.1999, p. 3., (EC) No 418/2001OJ L 62, 2.3.2001, p. 3. and (EC) No 162/2003OJ L 26, 31.1.2003, p. 3. authorised that additive for 10 years for use for chickens for fattening, turkeys for fattening and chickens reared for laying respectively, linking the authorisation to the person responsible for putting that additive into circulation. That additive was notified as an existing product in accordance with Article 10 of Regulation (EC) No 1831/2003. Since all the information required under that provision was submitted, that additive was entered into the Community Register of Feed Additives.(2)Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). The holder of the authorisation of the additive diclazuril (Clinacox 0,5 % Premix) has submitted an application with which it proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority. At the same time it provided the necessary data to support that request.(3)In its opinion adopted on 16 April 2008Updated Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on the Maximum Residue Limits for Clinacox 0,5 % (diclazuril) for turkeys for fattening, chickens for fattening and chickens reared for laying. The EFSA Journal (2008) 696, 1-12., the Authority concluded that no MRLs are required for chickens and turkeys for fattening. However, in case MRLs were considered necessary, it suggested values. Because it is possible that the chickens reared for laying enter in the food chain, not separately from the other chickens, it is necessary to consider the possibility to provide MRLs also for that animal category. It also considered that applying a withdrawal period of zero days would not compromise consumer safety.(4)To ensure a high level of safety for the consumers and to improve the controls of the correct use of diclazuril, it is appropriate to establish MRLs as proposed by the Authority. Because there are no relevant physiological differences between the chickens for fattening and chickens reared for laying it is appropriate to establish the same MRLs also for the latter category.(5)Commission Regulations (EC) No 2430/1999, (EC) No 418/2001 and (EC) No 162/2003 should therefore be amended accordingly.(6)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 1In Annex I to Regulation (EC) No 2430/1999 the line for E 771 is replaced by the text in Annex I to this Regulation.
Article 2Annex III to Regulation (EC) No 418/2001 is replaced by the text in Annex II to this Regulation.
Article 3The Annex to Regulation (EC) No 162/2003 is replaced by the text in Annex III to this Regulation.
Article 4This Regulation shall enter into force on the 20th 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, 6 October 2008.For the CommissionAndroulla VassiliouMember of the CommissionANNEX I
Coccidiostats and other medicinal substances
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
"E 771Janssen Pharmaceutica nvDiclazuril0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril0,2 g/100 g(Clinacox 0,2 % Premix)Additive composition:Diclazuril: 0,5 g/100 gSoybean meal: 99,25 g/100 gPolyvidone K 30: 0,2 g/100 gSodium hydroxide: 0,0538 g/100 gDiclazuril: 0,2 g/100 gSoybean meal: 39,7 g/100 gPolyvidone K 30: 0,08 g/100 gSodium hydroxide: 0,0215 g/100 gWheat middling: 60 g/100 gActive substance:DiclazurilC17H9Cl3N4O2,(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,CAS number: 101831-37-2Related impurities:Degradation compound (R064318): ≤ 0,2 %Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individuallyTotal impurities: ≤ 1,5 %Chickens for fattening—11—30.9.20091500 μg diclazuril/kg of wet liver1000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat"
ANNEX II"ANNEX III
Coccidiostats and other medicinal substances
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
E 771Janssen Pharmaceutica nvDiclazuril0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril0,2 g/100 g(Clinacox 0,2 % Premix)Additive composition:Diclazuril: 0,5 g/100 gSoybean meal: 99,25 g/100 gPolyvidone K 30: 0,2 g/100 gSodium hydroxide: 0,0538 g/100 gDiclazuril: 0,2 g/100 gSoybean meal: 39,7 g/100 gPolyvidone K 30: 0,08 g/100 gSodium hydroxide: 0,0215 g/100 gWheat middling: 60 g/100 gActive substance:DiclazurilC17H9Cl3N4O2,(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,CAS number: 101831-37-2Related impurities:Degradation compound (R064318): ≤ 0,2 %Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individuallyTotal impurities: ≤ 1,5 %Turkeys for fattening12 weeks11—28.2.20111500 μg diclazuril/kg of wet liver1000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat"
ANNEX III"ANNEX
Coccidiostats and other medicinal substances
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff
E 771Janssen Pharmaceutica nvDiclazuril0,5 g/100 g(Clinacox 0,5 % Premix)Diclazuril0,2 g/100 g(Clinacox 0,2 % Premix)Additive composition:Diclazuril: 0,5 g/100 gSoybean meal: 99,25 g/100 gPolyvidone K 30: 0,2 g/100 gSodium hydroxide: 0,0538 g/100 gDiclazuril: 0,2 g/100 gSoybean meal: 39,7 g/100 gPolyvidone K 30: 0,08 g/100 gSodium hydroxide: 0,0215 g/100 gWheat middling: 60 g/100 gActive substance:DiclazurilC17H9Cl3N4O2,(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phenyl]acetonitrile,CAS number: 101831-37-2Related impurities:Degradation compound (R064318): ≤ 0,2 %Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individuallyTotal impurities: ≤ 1,5 %Chickens reared for laying16 weeks11—20.1.20131500 μg diclazuril/kg of wet liver1000 μg diclazuril/kg of wet kidney500 μg diclazuril/kg of wet muscle500 μg diclazuril/kg of wet skin/fat"