Guidance on medicines for food and non-food horses and record keeping requirements including the horse passport.
If you are a vet, retailer, horse owner or keeper you must comply with certain legal requirements when administering medicines to and recording the use of medicines in horses.
Horses, including donkeys, zebras etc, are considered to be food-producing animals in the EU.
All horses must have a passport. In the passport horses can be declared as either intended for human consumption (food-producing) or not intended for human consumption (non-food-producing).
Whether or not a horse is declared as intended for human consumption determines what medicines can be administered to the animal and the records that have to be kept.
Medicines for horses
Horses should be treated with veterinary medicines which have a UK marketing authorisation (MA) for use in horses as the first choice. If there is no suitable authorised medicine available, for animals under their care a vet may prescribe an alternative medicine under the prescribing cascade.
However, a food-producing horse can only be treated with:
- a veterinary medicine that contains an active substance(s) in the legally permitted essential substances list for such horses (see below)
- a veterinary medicine that contains an active substance listed in table 1 of Commission Regulation 37/2010 on pharmacologically active substances and their classification regarding MRL in foodstuffs of animal origin
Essential substance list for horses
There is a list of substances considered essential for the treatment of equidae that may be used in food horses legally. These substances can only be used with a withdrawal period of six months.
The withdrawal period is the time between the last dose given to the animal and when the animal can be slaughtered for human consumption. Until the withdrawal period has ended, the animal or its products must not be consumed.
If any substance which is not on this list or is not listed in table one of 37/2010, such as phenylbutazone, is administered to an animal, that animal must be permanently excluded from the food chain and the declaration in the passport signed by either the horse owner, its keeper or the vet.
Selection of medicines for horses
If, as a vet you prescribe, administer or dispense any medicine for use in a horse you must:
ask to be shown the passport for the horse if you do not have prior knowledge of its status (if you have seen the passport recently and are aware of the horse’s current status, you do not have to see it before each treatment)
satisfy yourself that the passport supplied relates to the horse in question
note whether the horse is declared as ‘intended’ for human consumption in the passport or there is no declaration or the horse is declared as ‘not intended’ for human consumption. If the declaration is not signed, you must consider the horse as being ‘intended’ for human consumption
satisfy yourself it is a valid passport (if the document does not contain Section IX, it is not a valid horse passport).
If you do not have prior knowledge of the horse’s status and a passport is not available, or if you are not satisfied that the passport relates to the horse in question, follow the Horse is presented without passport procedure.
Horse declared not intended for human consumption
You should treat the horse with veterinary medicines which have a UK MA for use in horses as the first choice.
The Product Information Database holds information on every veterinary medicine authorised for use in the UK.
If there is no suitable authorised product available, the cascade may be used to prescribe an alternative medicine.
Horse declared intended for human consumption or no declaration made
You must consider the types of product that can be used and information to be entered on the passport.
Type of product - Products authorised for food-producing horses, in the UK or EU (imported under a Special Import Certificate (SIC)) containing pharmacologically active substances which are listed in Table 1 of Regulation EU 37/2010 and have a determined withdrawal period for horses.
Passport record - Meat and milk withdrawal period as stated on the product label and in the SPC must be followed and recorded but this does not need to be in the passport.
Type of product - Veterinary medicines authorised in the UK or EU which contain an active substance which is allowed to be administered to one or more food-producing species in accordance with Table 1 of Regulation EU 37/2010. This includes authorised products for other food-producing species and some products indicated for non-food-producing horses.
These products may only be prescribed by a vet under the cascade provisions.
Passport record - It is the responsibility of the vet to set a suitable withdrawal period. This must be recorded but this does not have to be in the passport. The withdrawal period must be at least 28 days (meat) or 7 days (milk) or the withdrawal period in the SPC of the product, whichever is longer.
Type of product - Products containing active substances in the list of essential substances. This list relates to both authorised veterinary medicines and extemporaneous prepared medicines containing these substances.
These products may only be prescribed by a vet under the cascade provisions.
Passport record - The details of the essential substances administered and the date of last administration as prescribed must be recorded in the passport. A statutory six months’ withdrawal period must be set and the owner or keeper notified of this.
Product types that cannot be used
The use of any products that contain an active substance which is not contained within Table 1 (the Allowed List) of Regulation EU 37/2010 or on the list of Essential Substances, such as phenylbutazone, will automatically mean that the horse must be permanently excluded from the food chain.
Medicines containing substances included on the ‘Prohibited Substances’, Table 2 of Regulation 37/2010. As a vet, you should check this list regularly for changes.
If a product from either of these categories is administered to an animal, that animal must be permanently excluded from the food chain and the passport declaration should be completed at Part II of Section IX by the owner or by the vet.
Some veterinary medicines have been authorised in the UK that contain active substances in the Allowed Substances list, but are indicated for use in non-food horses only on the label. This is because the manufacturers did not intend to market these products for food-producing horses and therefore did not undertake the tests that would be required to provide residue depletion data. To allow label harmonisation with such products authorised in several Member States, some products may state on the label:
‘Treated horses may never be slaughtered for human consumption’.
This statement does not apply if the product contains a substance in the essential substances list and has been prescribed by a vet in accordance with the cascade provisions, as explained above. In this case, a suitable withdrawal period needs to be observed, ie at least the minimum statutory cascade withdrawal period, or the withdrawal period indicated on the product’s Summary of Product Characteristics (SPC) for another food-producing species, whichever is longer.
Horse presented without a passport
If the owner or keeper of a horse does not have the passport for the horse to hand at the time of treatment, and the vet has not previously seen it, the vet must presume the horse is intended for human consumption.
The vet must only prescribe, dispense or administer medicines that are authorised for use in food-producing horses, or those that are not authorised for use in horses but contain substances in Table 1 of Commission Regulation 37/2010 for use in other food-producing animals.
Where the health or welfare of a horse is at risk and treatment with a substance that is not allowed for a food-producing animal is required (eg Etorphine), the vet must issue a document which details the medicines given and an instruction to the owner or keeper to exclude the animal from the food chain (if necessary). An example of this document can be obtained from British Equine Veterinary Association (BEVA). The vet should retain a copy of this document.
No passport has ever been issued
The vet should inform the owner or keeper they need to obtain a passport for the animal from the relevant Passport Issuing Organisation. If above 1 year of age, the horse will be declared as not intended for human consumption. This will be irreversible for the rest of its life.
The horse owner or keeper should apply to the Passport Issuing Organisation for a replacement or duplicate passport which will be over stamped ‘Not intended for human consumption’.
Passport exists but is not available
The vet must issue a document which details the medicines given to the horse. Depending on the substances given to the horse, the owner or keeper may have to exclude the animal from the food chain. The vet should retain a copy of this document.
Phenylbutazone cannot be used in a food-producing animal. This is a non-steroid anti-inflammatory drug which can be used for non-food animals and is useful in treating orthopaedic conditions.
Horses treated with phenylbutazone must not enter the food chain, and their passports must be signed to declare that the animal is not intended for human consumption. This is an irreversible decision.
Record keeping requirements for vets, retailers and horse owners or keepers
All vaccines administered must be recorded in the passport and certified by a vet regardless of whether or not the horse is intended for human consumption.
Non-food producing horses
There is no legal requirement to record any other medicines in the non-food horse’s passport.
These legal requirements apply to vets, horse owners or keepers, pharmacists and Suitably Qualified Persons:
Any substance on the essential substances list must be recorded in the passport
Record of use for any veterinary medicine must be kept
Records can be kept either in the passport or in a separate record as long as a written record is kept
Medicines records must be kept for 5 years even if the animal has been sold or slaughtered during that time
For further information on record keeping requirements see Record keeping requirements for veterinary medicines.
Important points for vets poster: