# Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (Text with EEA relevance), Division 3.1.1.2: Duration of tolerance trials Extent: E+W+S+N.I. 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). --- Source: https://www.legislation.gov.uk/eur/2008/429/annex/II/division/3/division/3.1/division/3.1.1/division/3.1.1.2 (the official version) Page: https://openlegislation.uk/eu-regulation-2008-429/annex-II/division-3/division-3.1/division-3.1.1/division-3.1.1.2 Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.