14.2.2006 EN Official Journal of the European Union L 42/22
COMMISSION REGULATION (EC) No 249/2006
of 13 February 2006
amending Regulations (EC) No 2430/1999, (EC) No 937/2001, (EC) No 1852/2003 and (EC) No 1463/2004 as regards the terms of the authorisation of certain additives in feedingstuffs 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 nutrition (1), and in particular Article 13(3) thereof,
Whereas:
(1) Article 13(3) of Regulation (EC) No 1831/2003 provides for the possibility of changing the terms of authorisation of an additive further to an application from the holder of the authorisation.
(2) The use of the additive halofuginone hydrobromide 6 g/kg (Stenorol) belonging to the group of ‘Coccidiostats and other medicinal substances’ was authorised for 10 years for chickens for laying by Commission Regulation (EC) No 2430/1999 (2). The authorisation was linked to the person responsible for putting the additive into circulation.
(3) The use of the additive salinomycin sodium 120 g/kg (Sacox 120) belonging to the group of ‘Coccidiostats and other medicinal substances’ was authorised for 10 years for rabbits for fattening by Commission Regulation (EC) No 937/2001 (3). The authorisation was linked to the person responsible for putting the additive into circulation.
(4) The use of the additive salinomycin sodium 120 g/kg (Sacox 120 microGranulate) belonging to the group of ‘Coccidiostats and other medicinal substances’ was authorised for 10 years for chickens reared for laying by Commission Regulation (EC) No 1852/2003 (4). The authorisation was linked to the person responsible for putting the additive into circulation.
(5) The use of the additive salinomycin sodium 120 g/kg (Sacox 120 microGranulate) belonging to the group of ‘Coccidiostats and other medicinal substances’ was authorised for 10 years for chickens for fattening by Commission Regulation (EC) No 1463/2004 (5). The authorisation was linked to the person responsible for putting the additive into circulation and replaced the previous authorisation of this additive which was not linked to any specific person.
(6) The holder of the authorisations, Hoechst Roussel Vet GmbH and Intervet International BV, have submitted applications pursuant to Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the person responsible for putting into circulation the additives referred to in recitals 2 to 5. With the application they have submitted data showing that the marketing rights for those additives have been transferred to Huvepharma NV with effect from 1 August 2005.
(7) Assigning the authorisation of an additive linked to a person responsible for putting it into circulation to another person, is based on a purely administrative procedure and did not entail a fresh assessment of the additives. The European Food Safety Authority was informed of the application.
(8) To allow Huvepharma NV to exploit its ownership rights, it is necessary to change the name of the person responsible for putting the additives into circulation accordingly.
(9) Regulations (EC) No 2430/1999, (EC) No 937/2001, (EC) No 1852/2003 and (EC) No 1463/2004 should therefore be amended accordingly.
(10) It is appropriate to provide for a transitional period during which existing stocks may be used up.
(11) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
In column 2 of the entry for E 764 of the Annex I to Regulation (EC) No 2430/1999, the words ‘Hoechst Roussel Vet GmbH’ are replaced by the words ‘Huvepharma nv’.
In column 2 of the entry for E 766 of Annex IV to Regulation (EC) No 937/2001, the words ‘Intervet International BV’ are replaced by the words ‘Huvepharma NV’.
In column 2 of the entry for E 766 of the Annex to Regulation (EC) No 1852/2003, the words ‘Intervet International BV’ are replaced by the words ‘Huvepharma NV’.
In column 2 of the entry for E 766 of the Annex to Regulation (EC) No 1463/2004, the words ‘Intervet International BV’ are replaced by the words ‘Huvepharma NV’.
Existing stocks which are in conformity with the provisions applicable before the entry into force of this Regulation may continue to be placed on the market and used until 31 July 2006.
This Regulation shall enter into force on the third day following 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.