Division 3.1.1.2 Duration of tolerance trials
United Kingdom
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).