(fra kommisjonsforordningen)

(1) Commission Implementing Regulation (EU) 2025/901 (2) establishes a list of substances which are essential for the treatment of equine species, or which bring added clinical benefit compared to other treatment options available for equine species and for which the withdrawal period for equine species is to be six months.

(2) Under Implementing Regulation (EU) 2025/901, a substance only qualifies as an ‘essential substance’ where no satisfactory alternative for the treatment or diagnosis of an indication is available and where the condition would, if untreated, create unnecessary suffering for the animal. A substance only qualifies as ‘bringing added clinical benefit’ where it provides a clinically relevant advantage based on improved efficacy or safety or a major contribution to treatment or diagnosis. This may be the result, inter alia, of different modes of action, different pharmacokinetic or pharmacodynamic profiles, different lengths of treatment or different routes of administration.

(3) Since the adoption of Implementing Regulation (EU) 2025/901, new information has emerged indicating that griseofulvin, ketoconazole, midazolam, rifampicin and sevoflurane may meet the criteria for essential substances or bring added clinical benefit compared to other treatment options available for equine species when used for specific indications.

(4) The Commission requested (3) the European Medicines Agency (‘the Agency’) to examine that information and to provide guidance in accordance with Article 141(1), point (f), of Regulation (EU) 2019/6. In its resulting guidance (4), the Agency concluded that the substances griseofulvin, ketoconazole, midazolam and sevoflurane can be considered essential or to bring added clinical benefit compared to other treatment options available for equine species when used for the indications proposed.

(5) As part of the Commission’s request, the Agency also assessed whether a withdrawal period of six months would be sufficient in respect of the equine animals treated with the substances found to be essential or to bring added clinical benefit for the proposed indications. The Agency could not exclude risks associated with griseofulvin and ketoconazole when used for all or for some of the indications proposed for each of those substances, even if a withdrawal period of six months is observed. The Agency’s scientific advice (5), which informed Implementing Regulation (EU) 2025/901, reached similar conclusions in respect of digoxin, dorzolamide, imipramine and phenytoin.

(6) Commission Regulation (EC) No 1950/2006 (6) continues to apply until 21 May 2027. To maintain a high level of consumer safety, it is appropriate to discontinue the use of those substances in accordance with Regulation (EC) No 1950/2006.

(7) Commission Implementing Regulation (EU) 2022/1255 (7) reserved the class of carboxypenicillins for the treatment of certain infections in humans. The use of the substance ticarcillin in animals is therefore not allowed in the Union. Since Regulation (EC) No 1950/2006 applies until 21 May 2027 and to ensure legal certainty for the competent authorities, veterinarians, animal keepers and economic operators concerned, it is appropriate to remove that substance from the list in the Annex to Regulation (EC) No 1950/2006.

(8) Implementing Regulation (EU) 2025/901 and Regulation (EC) No 1950/2006 should therefore be amended accordingly.

(9) To avoid consumer safety risks, to increase the availability of medicinal products to food-producing animals of the equine species and to avoid unacceptable suffering of those animals, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,