Categories and definitions of target animals and indication of the minimum duration of efficacy studies
ANNEX IVSupplementary provisions
ANNEX IV Categories and definitions of target animals and indication of the minimum duration of efficacy studies 1. Table. Animal categories: Pigs Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term efficacy studies Period/age Age Weight Piglets (suckling) Young porcine animals getting milk from sows From birth Up to 21-42 days Up to 6-11 kg 14 days Piglets (weaned) Young porcine animals having completed the suckling period and being reared for reproduction or meat production From 21-42 days Up to 120 days Up to 35 kg 42 days Piglets (suckling and weaned piglets) Young porcine animal from birth being reared for reproduction or meat production purposes From birth Up to 120 days Up to 35 kg 58 days Pigs for fattening Porcine animals having completed the weaning period and intended for meat production until day of transport to slaughterhouse From 60-120 days Up to 120-250 days (or according to local custom) 80-150 kg (or according to local custom) Until slaughter weight, but not less than 70 days Sows for reproduction Female porcine animals having been inseminated/mated at least once From first insemination From insemination to the end of the second weaning period (two cycles) Sows, in order to have benefit in piglets Female porcine animals having been inseminated/mated at least once At least two weeks before the parturition until the end of weaning period 2. Table. Animal categories: Poultry Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Chickens for fattening Birds raised for fattening From hatching Up to 35 days Up to ~1 600 g(up to 2 kg) 35 days Chickens reared for laying Female birds being reared for consumer egg production or for breeding purposes From hatching Up to ~16 weeks (up to 20 weeks) — 112 days (if the efficacy data are not available for chickens for fattening) Laying hens Productive female birds held for egg production purposes From 16-21 weeks Up to ~13 months (up to 18 months) From 1 200 g (white) 1 400 g (brown) 168 days Turkeys for fattening Birds raised for fattening From hatching Up to ~14 weeks (up to 20 weeks) Up to ~16 weeks (up to 24 weeks) Hens: up to ~7 000 g (up to 10 000 g) Cocks: up to ~12 000 g (up to 20 000 g) 84 days Turkeys for breeding purposes Female and male birds held for breeding purposes Whole period From 30 weeks up to ~ 60 weeks Hens: from ~15 000 g Cocks: from ~30 000 g At least six months Turkeys reared for breeding Young female and male birds reared for breeding purposes From hatching Up to 30 weeks Hens: up to ~15 000 g Cocks: up to ~30 000 g Whole period (if the efficacy data are not available for turkeys for fattening) 3. Table. Animal categories: Bovines (domestic bovine animals including bubalus and bison species) Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Calves for rearing Calves which are reared for reproduction or for beef production From birth Up to 4 months Up to 60-80 kg up to 145 kg) 56 days Calves for fattening Calves for veal production From birth Up to 6 months Up to 180 kg (up to 250 kg) Until slaughter but not less than 84 days Cattle for fattening Bovine animals that have completed the weaning period and are destined for meat production until day of transport to slaughterhouse From full development of rumination Up to 10-36 months Up to 350-700 kg 168 days Dairy cows for milk production Female bovine animals that have produced at least one calf. 84 days (total lactation period shall be reported) Cows for reproduction Female bovine animals that have been inseminated/mated at least once From first insemination to the end of second weaning period Two cycles (if the reproduction parameters are requested) 4. Table. Animal categories: Sheep Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Lambs for rearing Lambs reared for future reproduction From birth Up to 3 months 15-20 kg 56 days Lambs for fattening Lambs that are reared for lamb meat production. From birth Up to 6 months (or older) up to 55 kg Until slaughter weight but not less than 56 days Dairy sheep (for milk production) Sheep that have produced at least one lamb 84 days (total lactation period shall be reported) Ewes for reproduction Female sheep that have been inseminated/mated at least once From first insemination to the end of second weaning period Two cycles (if the reproduction parameters are requested) 5. Table. Animal categories: Goats Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Kids for rearing Young goats reared for future reproduction From birth Up to 3 months 15-20 kg At least 56 Kids for fattening Young goats that are reared for goat meat production From birth Up to 6 months At least 56 days Dairy goats (for milk production) Goats that have produced at least one kid 84 days (total lactation period shall be reported) Goats for reproduction Female goats that have been inseminated/mated at least once From first insemination to the end of second weaning period Two cycles (if the reproduction parameters are requested) 6. Table. Animal categories: Fish Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Salmon and trout 200-300 g 90 days or until initial body weight is doubled. Salmon and trout Brood stock As close to the spawning period as possible 90 days 7. Table. Animal categories: Rabbits Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Rabbits suckling and weaned Beginning one week after birth 56 days Rabbits for fattening Rabbits that are reared for meat production After weaning period Up to 8-11 weeks 42 days Breeding does (for reproduction) Does, that have been inseminated/mated at least once From the insemination to the end of the second weaning period Two cycles (if the reproduction parameters are requested). Breeding does (in order to have benefits to young rabbits) Does, that have been inseminated at least once From first insemination At least 2 weeks before parturition until the end of the weaning period (e.g. for micro-organism product) 8. Table. Animal Categories: horses Category Definition of the animal category Approximate duration period (weight/age) Minimum duration of long term studies for efficacy Period Age Weight Horses All categories 56 days