Commission Regulation (EC) No 429/2008Show full title

3.1.1.2. Duration of tolerance trials

Table 1

Duration of tolerance trials: Pigs

Target animals	Duration of the studies	Characteristic of the target animals
Suckling piglets	14 days	Preferably from 14 days to weaning
Weaned piglets	42 days	For 42 days after weaning
Pigs for fattening	42 days	Body weight at start of the study ≤ 35 kg
Sows for reproduction	1 cycle	From insemination to the end of the weaning period

If suckling and weaned piglets are applied for, a combined study (14 days suckling piglets and 28 days weaned piglets) would be considered sufficient. If the tolerance for weaned piglets has been shown, no separate study for pigs for fattening is required.

Table 2

Duration of tolerance trials: Poultry

Target animals	Duration of the studies	Characteristic of the target animals
Chickens for fattening/reared for laying	35 days	From hatching
Laying hens	56 days	Preferably during the first third of the laying period
Turkeys for fattening	42 days	From hatching

Tolerance data from chickens for fattening or turkeys for fattening can be used to demonstrate tolerance for chickens or turkeys reared for laying/breeding respectively.

Table 3

Duration of tolerance trials: Bovines

Target animals	Duration of the studies	Characteristic of the target animals
Calves for fattening	28 days	Initial bodyweight ≤ 70kg
Calves for rearing; cattle for fattening or reproduction	42 days
Dairy cows	56 days

If calves for rearing and cattle for fattening were applied for, a combined study (28 days for each period) would be considered sufficient.

Table 4

Duration of tolerance trials: Sheep

Target animals	Duration of the studies	Characteristic of the target animals
Lambs for rearing and for fattening	28 days

Table 5

Duration of tolerance trials: Salmonidae and other fish

Target animals	Duration of the studies	Characteristic of the target animals
Salmon and trout	90 days

As an alternative to a 90-day duration, a study could be performed where the fish increase their initial body weight at the start of the trial by least a factor of two.

If the additive is intended to be used for brood stock only, the tolerance tests shall be carried out as close to the spawning period as possible. The tolerance tests shall last for 90 days and attention shall be paid to the egg quality and survival of the eggs.

Table 6

Duration of tolerance trials: Pets and other non food-producing animals

Target animals	Duration of the studies	Characteristic of the target animals
Dogs and cats	28 days

Table 7

Duration of tolerance trials: Rabbits

Target animals	Duration of the studies	Characteristic of the target animals
Rabbits for fattening	28 days
Breeding does	1 cycle	From insemination to the end of the weaning period

If rabbits suckling and weaned are applied for, a period of 49 days (beginning one week after birth) would be considered sufficient and must include the does until weaning.

If an additive is applied for a specific and shorter period than given by the animal category definition, it shall be administered according to the proposed conditions of use. However, the observation period shall not be shorter than 28 days and shall involve the relevant end-point (e.g. for sows for reproduction the number of piglets born alive when considering the gestation period, or the number and weight of weaned piglets when considering the lactation period).