ANNEX IVCategories 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