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

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)

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ANNEX IVCategories and definitions of target animals and indication of the minimum duration of efficacy studies

1.Table. Animal categories: Pigs

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term efficacy studies
Period/ageAgeWeight
Piglets (suckling)Young porcine animals getting milk from sowsFrom birthUp to 21-42 daysUp to 6-11 kg14 days
Piglets (weaned)Young porcine animals having completed the suckling period and being reared for reproduction or meat productionFrom 21-42 daysUp to 120 daysUp to 35 kg42 days
Piglets (suckling and weaned piglets)Young porcine animal from birth being reared for reproduction or meat production purposesFrom birthUp to 120 daysUp to 35 kg58 days
Pigs for fatteningPorcine animals having completed the weaning period and intended for meat production until day of transport to slaughterhouseFrom 60-120 daysUp 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 reproductionFemale porcine animals having been inseminated/mated at least onceFrom first inseminationFrom insemination to the end of the second weaning period (two cycles)
Sows, in order to have benefit in pigletsFemale porcine animals having been inseminated/mated at least onceAt least two weeks before the parturition until the end of weaning period

2.Table. Animal categories: Poultry

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term studies for efficacy
PeriodAgeWeight
Chickens for fatteningBirds raised for fatteningFrom hatchingUp to 35 daysUp to ~1 600 g(up to 2 kg)35 days
Chickens reared for layingFemale birds being reared for consumer egg production or for breeding purposesFrom hatching

Up to ~16 weeks

(up to 20 weeks)

112 days (if the efficacy data are not available for chickens for fattening)
Laying hensProductive female birds held for egg production purposesFrom 16-21 weeks

Up to ~13 months

(up to 18 months)

From 1 200 g (white) 1 400 g (brown)168 days
Turkeys for fatteningBirds raised for fatteningFrom 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 purposesFemale and male birds held for breeding purposesWhole periodFrom 30 weeks up to ~ 60 weeks

Hens: from ~15 000 g

Cocks: from ~30 000 g

At least six months
Turkeys reared for breedingYoung female and male birds reared for breeding purposesFrom hatchingUp 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)

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term studies for efficacy
PeriodAgeWeight
Calves for rearingCalves which are reared for reproduction or for beef productionFrom birthUp to 4 monthsUp to 60-80 kg up to 145 kg)56 days
Calves for fatteningCalves for veal productionFrom birthUp to 6 months

Up to 180 kg

(up to 250 kg)

Until slaughter but not less than 84 days
Cattle for fatteningBovine animals that have completed the weaning period and are destined for meat production until day of transport to slaughterhouseFrom full development of ruminationUp to 10-36 monthsUp to 350-700 kg168 days
Dairy cows for milk productionFemale bovine animals that have produced at least one calf.84 days (total lactation period shall be reported)
Cows for reproductionFemale bovine animals that have been inseminated/mated at least onceFrom first insemination to the end of second weaning periodTwo cycles (if the reproduction parameters are requested)

4.Table. Animal categories: Sheep

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term studies for efficacy
PeriodAgeWeight
Lambs for rearingLambs reared for future reproductionFrom birthUp to 3 months15-20 kg56 days
Lambs for fatteningLambs that are reared for lamb meat production.From birthUp to 6 months (or older)up to 55 kgUntil slaughter weight but not less than 56 days
Dairy sheep (for milk production)Sheep that have produced at least one lamb84 days (total lactation period shall be reported)
Ewes for reproductionFemale sheep that have been inseminated/mated at least onceFrom first insemination to the end of second weaning periodTwo cycles (if the reproduction parameters are requested)

5.Table. Animal categories: Goats

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term studies for efficacy
PeriodAgeWeight
Kids for rearingYoung goats reared for future reproductionFrom birthUp to 3 months15-20 kgAt least 56
Kids for fatteningYoung goats that are reared for goat meat productionFrom birthUp to 6 monthsAt least 56 days
Dairy goats (for milk production)Goats that have produced at least one kid84 days (total lactation period shall be reported)
Goats for reproductionFemale goats that have been inseminated/mated at least onceFrom first insemination to the end of second weaning periodTwo cycles (if the reproduction parameters are requested)

6.Table. Animal categories: Fish

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term studies for efficacy
PeriodAgeWeight
Salmon and trout200-300 g90 days or until initial body weight is doubled.
Salmon and troutBrood stockAs close to the spawning period as possible90 days

7.Table. Animal categories: Rabbits

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term studies for efficacy
PeriodAgeWeight
Rabbits suckling and weanedBeginning one week after birth56 days
Rabbits for fatteningRabbits that are reared for meat productionAfter weaning periodUp to 8-11 weeks42 days
Breeding does (for reproduction)Does, that have been inseminated/mated at least onceFrom the insemination to the end of the second weaning periodTwo cycles (if the reproduction parameters are requested).
Breeding does (in order to have benefits to young rabbits)Does, that have been inseminated at least onceFrom 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

CategoryDefinition of the animal categoryApproximate duration period (weight/age)Minimum duration of long term studies for efficacy
PeriodAgeWeight
HorsesAll categories56 days

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