ANNEX I
Annexes I, II, III and IV to Regulation (EC) No 429/2008 are amended as follows:
(1)
Annex I is replaced by the following:
‘
ANNEX I
APPLICATION FORM REFERRED TO IN ARTICLE 2(1)
APPLICATION FORM
EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Subject: Application for authorisation of a feed additive in accordance with Regulation (EC) No 1831/2003.
Submission date: …
I. TYPE OF SUBMISSION
☐
Application for authorisation of a new feed additive (Article 4(1) of Regulation (EC) No 1831/2003)
☐
Application for authorisation of a new use and/or modification and/or renewal of the authorisation of a feed additive (Articles 4(1), 13(3), 14 of Regulation (EC) No 1831/2003):
☐
New use (Article 4 of Regulation (EC) No 1831/2003)
☐
Modification of an existing authorisation (Article 13(3) of Regulation (EC) No 1831/2003)
☐
Renewal of a feed additive authorisation (Article 14 of Regulation (EC) No 1831/2003)
☐
Submission of complementary information following Authority’s inconclusive opinion
II. SUBJECT OF THE APPLICATION
1. Subject of the application: provide the name of the substance, preparation or micro-organism;
—
if the application is submitted for the modification of an existing authorisation under Article 13(3), explain the modification that is requested,
—
if the application is submitted for the renewal of an existing authorisation under Article 14, explain any proposal for amending or supplementing the conditions of the original authorisation in accordance with Article 14(2)(d), as appropriate.
…
2. Identification and characterisation of the additive as defined in subsections 2.2.1.1 and 2.2.1.2 of Annex II to Regulation (EC) No 429/2008
Additive type(s) to be placed on the market:
☐
Substance
☐
Micro-organism
☐
Preparation
Name of additive: …
Trade name of the additive (required only for coccidiostats and histomonostats): …
Identifiers of the substance: …
3. Category/ies and functional group/s of additives ( 1 )
Category: …
Functional group: …
4. Target animal species and category(ies) as designated in Annex IV to Regulation (EC) No 429/2008
Species: …
Category: …
Additional precision or comment on the species/category: …
5. Proposed mode of use in animal nutrition
☐
Use in feed
☐
Use in water for drinking
☐
Special conditions of use
6. Existing authorisations, if applicable
Existing authorisation in the EU feed legislation:
Eur-Lex link: …
Functional group in which the feed additive is currently authorised: …
Identification number of the feed additive as currently authorised: …
Existing authorisation under the GMO legislation
Unique identifier (Commission Regulation (EC) No 65/2004 ( 2 ) (where appropriate): …
Has any authorisation been granted in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council?
☐
Yes
☐
No
Is there any pending application for authorisation under Regulation (EC) No 1829/2003 of the European Parliament and of the Council?
☐
Yes
☐
No
III. REFERENCE SAMPLES
Community Reference Laboratory (CRL) sample number (if applicable): …
IV. ADMINISTRATIVE DATA
1. Applicant’s administrative data
Applicant name (to be retained as the name of the authorisation holder, if applicable): …
Email: …
Phone number: …
Website: …
Address: …
Post code: …
Country: …
2. Applicant’s EU representative contact details (as necessary)
EU Representative name: …
Email: …
Phone number: …
Website: …
Address: …
Post code: …
Country: …
3. Contact person/Person responsible for the dossier contact details
Name of contact person / person responsible: …
Name of the entity/organisation: …
Email: …
Phone number: …
Website: …
Address: …
Post code: …
Country: …
’
(2)
Annex II is amended as follows:
(1)
in point 3.1.1.2, Table 2, Table 5 and Table 7 are replaced by the following:
‘ Table 2
Duration of tolerance trials: Poultry
Target animals
Duration of the studies
Characteristic of the target animals
Chickens for fattening and chickens reared for laying or reproduction
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/reproduction respectively.’;
‘ Table 5
Duration of tolerance trials: Salmonids
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 finfish 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 7
Duration of tolerance trials: Rabbits
Target animals
Duration of the studies
Characteristic of the target animals
Rabbits for fattening
28 days
Rabbit 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.’;
(2)
in point 3.2.1.2, the fifth subparagraph is replaced by the following:
‘For the determination of a withdrawal period, the suggested minimum number of animals sampled and/or products at each time point are the following:
—
edible tissues:
—
bovines, sheep, pigs and minor species: 4,
—
poultry: 6,
—
salmonids and other food-producing finfish: 10,
—
products:
—
milk: 8 samples per time point,
—
eggs: 10 eggs per time point,
—
honey: 8 samples per time point.’;
(3)
in point 3.2.3.3, the third subparagraph is replaced by the following:
‘For additives intended for multi-species, the exposure from tissues shall be independently calculated for mammals, poultry and food-producing finfish and the highest value taken. Where appropriate, exposure from milk and eggs shall be added to this figure. For example, where an additive is applied for lactating mammals and laying birds, the respective highest edible tissue values are added to those for milk and egg consumption. Where the additive is applied for food-producing finfish and laying birds and lactating mammals, the respective highest edible tissue values are added to those for egg and milk consumption. Other combinations shall be envisaged in the same way.’;
(4)
in point 3.2.3.3, the title of the third column of Table 1 is replaced by ‘Poultry’ and the title of the fourth column of Table 1 is replaced by ‘Food-producing finfish’;
(5)
in point 3.4.1.2, the first subparagraph is replaced by the following:
‘Feed additives used in aquaculture can result in contamination of sediment and water. The compartment of concern for the environmental risk assessment for food-producing finfish farmed in cages is assumed to be the sediment. For food-producing finfish farmed in land-based systems the effluent flowing to surface water is considered to pose the major environmental risk.’;
(6)
point 3.4.2.1 is replaced by the following:
‘Phase II A
In addition to the compartments considered in Phase I, the PEC for surface water has to be calculated considering runoff and drainage.
Based on data not considered in Phase I, a more refined PEC can be calculated for each environmental compartment of concern. In ascertaining the refined PEC, account shall be taken of:
(a)
the concentration of active substance(s)/metabolites of concern in manure/finfish faeces following administration of the additive to animals at the proposed dose level. This calculation shall include consideration of dosage rates and amount of excreta produced;
(b)
the potential degradation of the excreted active substance(s)/metabolites of concern during normal manure processing practice and storage prior to its application to land;
(c)
the adsorption/desorption of the active substance(s)/metabolites of concern onto soil or sediment for aquaculture, preferentially determined by studies in soil/sediment (OECD 106);
(d)
degradation in soil and water/sediment systems (OECD 307 and 308, respectively); and
(e)
other factors such as hydrolysis, photolysis, evaporation, dilution through ploughing.
The highest value for the PEC obtained from these calculations for each environmental compartment of concern shall be adopted for Phase II risk assessment purposes.
If a high persistence in soil/sediment is anticipated (time to degradation of 90 % of original concentration of the compound: DT 90 > 1 year), the potential for accumulation shall be considered.
The concentrations of additives (or metabolites) producing serious adverse effects for various trophic levels in the environmental compartments of concern shall be determined. These tests are mostly acute tests and should follow OECD or similar well-established guidelines. Studies for the terrestrial environment shall include: toxicity to earthworms; three terrestrial plants; and soil micro-organisms (e.g. effects on nitrogen fixation). Studies for the fresh water environment shall include: toxicity to finfish; Daphnia magna ; algae; and a sediment dwelling organism. In case of sea cages, three species of different taxa of sediment dwelling organisms shall be studied.
Calculation of the PNEC value shall be carried out for each compartment of concern. The PNEC is normally derived from the lowest toxicity value observed in the above tests and dividing by a safety factor of at least 100 depending on the endpoint and number of test species used.
The potential for bioaccumulation can be estimated from the value of the n-octanol/water partition coefficient, Log K ow . Values ≥ 3 indicate that the substance may bioaccumulated. In order to assess the risk for secondary poisoning it shall be considered whether to carry out a bioconcentration factor (BCF) study at Phase II B.’;
(7)
point 4.4 is replaced by the following:
‘4.4. Duration of long-term efficacy studies with target animals
In principle, the duration of efficacy trials shall correspond to the application period claimed.
Efficacy trials shall be carried out according to farming practices in the Union and be of the minimum duration as stated by Annex IV.
For minor species for which a minimum duration period of studies is not established in Annex IV, the minimum duration shall correspond to that of the physiologically related major species, as applicable. For other animal species and categories for which a minimum duration period of studies is not established in Annex IV, the minimum duration shall be 42 days for growing animals (from birth to slaughter or to entry in the reproduction period) and 56 days for adult animals (from entry in the reproduction period).
If an additive is applied for a specific and shorter period than normally applicable for the animal species or category, 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-points (e.g. for sows the number of piglets born alive when considering the gestation period, or the number and weight of weaned piglets when considering the lactation period).’;
(3)
Annex III is amended as follows:
(1)
in point 2.1.3, subparagraph (3) is replaced by the following:
‘(3)
For substances which favourably affect the colour of ornamental aquatic species or ornamental birds, studies concerning Section III subsection 3.1 of Annex II are required and shall be performed on animals receiving the additive at the recommended dose. Evidence can also be provided by reference to existing scientific literature. However, subsections 3.2 and 3.4 are not required.’;
(2)
in point 2.1.4, subparagraph (c) is replaced by the following:
‘(c)
For substances which favourably affect the colour of ornamental aquatic species and birds:
studies demonstrating the effect(s) shall be performed on animals receiving the additive at the recommended levels of use. Colour changes shall be measured using the appropriate methodology. Evidence of efficacy may also be provided by other experimental studies (e.g. bioavailability) or by reference to scientific literature.’;
(3)
in point 5.4, the first subparagraph is replaced by the following:
‘These additives protect the animals from the results of an invasion of Eimeria spp. or Histomonas meleagridis . Importance shall be attached to evidence of the specific effects of the additive (e.g. species controlled) and its prophylactic properties (e.g. reduction in morbidity, mortality, oocyst count and lesion score). Information on the effect on growth and feed conversion (fattening birds, replacement layers and rabbits), effects on hatchability (birds for reproduction) shall be provided, as appropriate.’;
(4)
in point 6, the first subparagraph is replaced by the following:
‘Major species and minor species are defined in Article 1(2) and (3) of this Regulation.’;
(5)
in point 6.3.1.1, the third subparagraph is replaced by the following:
‘If three major target species (including monogastric and ruminant mammals and poultry) showed a similar and wide margin of safety, no additional tolerance studies are required for non-physiologically similar minor species (e.g. horses or rabbits). Where tolerance is required, the duration of the studies for minor species (except rabbits) shall be at least 28 days for growing animals and 42 days for adult animals. For rabbits, the following durations apply: rabbits for fattening: 28 days; rabbit does: one 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) is considered sufficient and must include the does until weaning. For food-producing finfish (other than salmonids) a 90-day period is required.’;
(6)
point 6.3.2.3 is replaced by the following:
‘6.3.2.3.
Assessment of consumer safety
Proposal for Maximum Residue Limits (MRLs)
Setting of MRLs can be done by assuming that no significant differences in the content of residues occur in the edible tissues of minor species compared to a similar major species.
MRLs can be extrapolated within classes of animals as follows:
—
from major growing ruminants to all growing ruminants,
—
from milk of dairy cows to milk of other dairy ruminants,
—
from pigs to all monogastric mammals, excluding horses,
—
from chickens or turkeys to other poultry,
—
from laying hens to other laying birds, and
—
from salmonids to all food-producing finfish.
MRLs for horses could be extrapolated when MRLs for a major ruminant and a major monogastric mammal exist.
If identical MRLs were derived in cattle (or sheep), pigs and chicken (or poultry), which represent major species with different metabolic capacities and tissue composition, the same MRLs can also be set for ovines, equines and rabbits, which means an extrapolation is considered possible to all food-producing animals except food-producing aquatic animals. Considering the Committee for Medicinal Products for Veterinary Use (CVMP) guideline ( x ) on the establishment of MRLs for salmonids and other food-producing finfish, which already allows an extrapolation from MRLs in muscle of a major species to salmonids and other food-producing finfish provided that the parent substances is acceptable as marker residue for the MRL in muscle and skin, MRLs can be extrapolated to all food-producing animals.
Analytical methods shall be available for monitoring residues in edible tissue and products of all food-producing animals.
( x ) Note for guidance of the establishment of maximum residue limits for Salmonidae and other fin fish. The European Agency for the Evaluation of Medicinal Products. Veterinary Medicines Evaluation Unit. EMEA/CVMP/153b/97-FINAL.’;"
( ) Note for guidance of the establishment of maximum residue limits for Salmonidae and other fin fish. The European Agency for the Evaluation of Medicinal Products. Veterinary Medicines Evaluation Unit. EMEA/CVMP/153b/97-FINAL.’;
(4)
Annex IV is replaced by the following:
‘
ANNEX IV
DESIGNATION OF THE TARGET ANIMAL CATEGORIES AND MINIMUM DURATION OF THE LONG-TERM EFFICACY STUDIES
1. Porcine species ( Suidae )
Animal species
Animal category
Definition of the animal category
Approximate weight/age in the category
Minimum duration of long-term efficacy studies
Period/age
Age
Weight
Pigs
Suckling piglets
Piglets getting milk from sows, reared for reproduction or meat production, from birth until weaning
Up to 21-42 days
Up to 6 -11 kg
Weaned piglets
Piglets reared for reproduction or meat production, having completed the suckling period until the end of the post-weaning period (transition period)
From 21-42 days
Up to 120 days
Up to 35 kg
42 days
35 days, if the growth rate is ≥ 0,5 kg/day
Piglets
Piglets reared for reproduction or meat production, from birth until the end of the post-weaning period (transition period)
Up to 120 days
Up to 35 kg
Pigs for fattening
Pigs for meat production, from the end of the post-weaning period (transition period) until date of slaughter
From 60-120 days
Up to 120-250 days (or according to local custom)
80 -150 kg (or according to local custom)
Until slaughter, but not less than 70 days
Pigs reared for reproduction
Females (gilts) and males reared for reproduction, from the end of the post-weaning period (transition period) until entry in the reproduction period
Sows
Females for reproduction, which have mated or have been inseminated at least once
Two full reproduction cycles
Sows, in order to have benefit in piglets
Females for reproduction, which have mated or have been inseminated at least once. For cases where the benefit of feeding the additive to the sows will be claimed in the piglets.
No later than from parturition until the end of the weaning period (but no less than 28 days)
Boars
Males for reproduction, from entry in the reproduction period
Pigs
All categories of pigs
Minor porcine species
Suckling piglets of minor porcine species
Piglets of all minor porcine species getting milk from sows, reared for reproduction or meat production, from birth until weaning
Weaned piglets of minor porcine species
Piglets of all minor porcine species reared for reproduction or meat production, having completed the suckling period until the end of the post-weaning period (transition period)
Piglets of minor porcine species
Piglets of all minor porcine species reared for reproduction or meat production, from birth until the end of the post-weaning period (transition period)
Minor porcine species for fattening
Animals of all minor porcine species for meat production, from the end of the post-weaning period (transition period) until date of slaughter
Minor porcine species reared for reproduction
Animals of all minor porcine species reared for reproduction, from the end of the post-weaning period (transition period) until entry in the reproduction period
Sows of minor porcine species
Females of all minor porcine species for reproduction, which have mated or have been inseminated at least once
Boars of minor porcine species
Males of all minor porcine species for reproduction, from entry in the reproduction period
Minor porcine species
All species and categories of all minor porcine species
Porcine species
Suckling piglets of porcine species
Piglets of all porcine species getting milk from sows, reared for reproduction or meat production, from birth until weaning
Weaned piglets of porcine species
Piglets of all porcine species reared for reproduction or meat production, having completed the suckling period until the end of the post-weaning period (transition period)
Piglets of porcine species
Piglets of all porcine species reared for reproduction or meat production, from birth until the end of the post-weaning period (transition period)
Porcine species for fattening
Animals of all porcine species for meat production, from the end of the post-weaning period (transition period) until date of slaughter
Porcine species reared for reproduction
Animals of all porcine species reared for reproduction, from the end of the post-weaning period (transition period) and until entry in the reproduction period
Sows of porcine species
Females of all porcine species for reproduction, which have mated or have been inseminated at least once
Boars of porcine species
Males of all porcine species for reproduction, from entry in the reproduction period
Porcine species
All species and categories of all porcine species
2. Poultry
Species
Animal category
Definition of the animal category
Approximate weight/age in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
Chickens
Chickens for fattening
Broilers for meat production, from hatching to slaughter
Up to 35 days
Up to ~1 600 g (up to 2 kg)
35 days
Chickens reared for laying or reproduction
Females and males reared for laying (consumer egg production) or reproduction, from hatching until entry in the laying or reproduction period
Up to ~16 weeks (up to 20 weeks)
Hens
Hens, from entry in the laying (consumer egg production) or reproduction period
From 16-21 weeks
Up to ~13 months (up to 18 months)
From 1 200 g (white)
1 400 g (brown)
84 days
Roosters
Roosters, from entry in the reproduction period
Chickens
All categories of chickens
Turkeys
Turkeys for fattening
Turkeys for meat production, from hatching to slaughter
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 reared for reproduction
Females and males reared for reproduction, from hatching until entry in the reproduction period
Up to 30 weeks
Hens: up to
~15 000 g
Cocks: up to
~30 000 g
Turkeys for reproduction
Female and male birds held for breeding purposes
From 30 weeks up to
~ 60 weeks
Hens: from
~15 000 g
Cocks: from
~30 000 g
Turkeys
All categories of turkeys
Minor poultry
Minor poultry for fattening
Females and males of all minor poultry species for meat production, from hatching to slaughter
Minor poultry reared for laying or reproduction
Females and males of all minor poultry species reared for laying (consumer egg production) or reproduction, from hatching until entry in the laying or reproduction period
Minor poultry for laying or reproduction
Females and males of all minor poultry species, from entry in the laying (consumer egg production) or reproduction period
Minor poultry
All species and categories of minor poultry
Poultry
Poultry for fattening
Females and males of all poultry species for meat production, from hatching to slaughter
Poultry reared for laying or reproduction
Females and males of all poultry species reared for laying (consumer egg production) or reproduction, from hatching until entry in the laying or reproduction period
Poultry for laying or reproduction
Females and males of all poultry species, from entry in the laying (consumer egg production) or reproduction period
Poultry
All species and categories of poultry
3. Ruminants
Species
Animal category
Definition of the animal category
Approximate weight/age in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
Cattle
Calves for fattening
Calves for veal production, from birth until date of slaughter
Up to 6 months
Up to 180 kg (up to 250 kg)
84 days
Calves for rearing
Calves reared for milk production/reproduction or for meat production, from birth up to 4 months
Up to 60 -80 kg (up to 145 kg)
56 days
Cattle for fattening
Cattle for meat production, other than calves for fattening and calves for rearing, until date of slaughter
From full development of rumination
Up to 10-36 months
Up to 350 -700 kg
84 days
Cattle reared for milk production / reproduction
Heifers and young bulls, other than calves for rearing, reared for milk production/reproduction, until entry in the reproduction period
Cows
Cows for milk production (dairy cows)/reproduction, which have mated or have been inseminated at least once
84 days
Two cycles, if the reproduction parameters are requested.
Bulls
Bulls for reproduction, from entry in the reproduction period
Cattle
All categories of cattle
Minor bovine species
Calves of minor bovine species for fattening
In all minor bovine species, calves for veal production, from birth until date of slaughter
Calves of minor bovine species for rearing
In all minor bovine species, calves reared for milk production/reproduction or for meat production, from birth up to 4 months
Minor bovines for fattening
In all minor bovine species, animals for meat production other than calves for fattening and calves for rearing, until date of slaughter
Minor bovines reared for milk production/reproduction
In all minor bovine species, heifers and young bulls other than calves for rearing, reared for milk production/reproduction, until entry in the reproduction period
Cows of minor bovine species
In all minor bovine species, cows for milk production/reproduction, which have mated or have been inseminated at least once
Bulls of minor bovine species
In all minor bovine species, bulls for reproduction, from entry in the reproduction period
Minor bovines
All species and categories of minor bovines
Bovines
Calves of bovine species for fattening
In all bovine species, calves for veal production, from birth until date of slaughter
Calves of bovine species for rearing
In all bovine species, calves reared for milk production/reproduction or for meat production, from birth up to 4 months
Bovines for fattening
In all bovine species, animals for meat production other than calves for fattening and calves for rearing, until date of slaughter
Bovines reared for milk production/reproduction
In all bovine species, heifers and young bulls other than calves for rearing, reared for milk production/reproduction, until entry in the reproduction period
Cows of bovine species
In all bovine species, cows for milk production/reproduction, which have mated or have been inseminated at least once
Bulls of bovine species
In all bovine species, bulls for reproduction, from entry in the reproduction period
Bovines
All species and categories of bovines
Sheep
Lambs for fattening
Lambs for lamb meat production, from birth until date of slaughter
Up to 6 months (or older)
up to 55 kg
56 days
Lambs for rearing
Lambs reared for milk production/reproduction, from birth up to 3 months
15 -20 kg
56 days
Sheep for fattening
Sheep for meat production other than lambs for fattening, until date of slaughter
Sheep reared for milk production / reproduction
Young sheep other than lambs for rearing, females and males, reared for milk production/reproduction, until entry in the reproduction period
Ewes
Ewes for milk production (dairy sheep)/reproduction, which have mated or have been inseminated at least once
84 days
Two cycles, if the reproduction parameters are requested.
Rams
Rams for reproduction, from entry in the reproduction period
Sheep
All categories of sheep
Ovines
Lambs of ovine species for fattening
In all ovine species, lambs for meat production, from birth until date of slaughter
Lambs of ovine species for rearing
In all ovine species, lambs reared for milk production/reproduction, from birth up to 3 months
Ovines for fattening
In all ovine species, ovines for meat production other than lambs for fattening, until date of slaughter
Ovines reared for milk production/reproduction
In all ovine species, young animals other than lambs for rearing, females and males, reared for milk production/reproduction, until entry in the reproduction period
Ewes of ovine species
In all ovine species, ewes for milk production/reproduction, which have mated or have been inseminated at least once
Rams of ovine species
In all ovine species, rams for reproduction, from entry in the reproduction period
Ovines
All species and categories of ovines
Goats
Kids for fattening
Kids for meat production, from birth until date of slaughter
Up to 6 months
56 days
Kids for rearing
Kids reared for milk production/reproduction, from birth up to 3 months
15 -20 kg
56 days
Goats for fattening
Goats for meat production other than kids for fattening, until date of slaughter
Goats reared for milk production / reproduction
Young goats other than kids for rearing, females and males, reared for milk production/reproduction, until entry in the reproduction period
Goat does
Female goats for milk production (dairy goats)/reproduction, which have mated or have been inseminated at least once
84 days
Two cycles, if the reproduction parameters are requested.
Goat bucks
Bucks (billy goats) for reproduction, from entry in the reproduction period
Goats
All categories of goats
Caprines
Kids of caprine species for fattening
In all caprine species, kids for meat production, from birth until date of slaughter
Kids of caprine species for rearing
In all caprine species, kids reared for milk production/reproduction), from birth up to 3 months
Caprines for fattening
In all caprine species, caprines for meat production other than kids for fattening, until date of slaughter
Caprines reared for milk production/reproduction
In all caprine species, young goats other than kids for rearing, females and males, reared for milk production/reproduction, until entry in the reproduction period
Does of caprine species
In all caprine species, female goats for milk production/reproduction, which have mated or have been inseminated at least once
Bucks of caprine species
In all caprine species, bucks for reproduction, from entry in the reproduction period
Caprines
All species and categories of caprines
Cervids
All species of cervids
Ruminants
Young ruminants for fattening
In all ruminant species, calves, lambs, kids, etc. for meat production, from birth until date of slaughter
Young ruminants for rearing
In all ruminant species, calves, lambs, kids, etc. reared for milk production/reproduction, from birth up to 4 months (bovines) or up to 3 months (ovines, caprines and cervids)
Ruminants for fattening
In all ruminant species, animals for meat production other than young ruminants for fattening, until date of slaughter
Ruminants reared for milk production/reproduction
In all ruminant species, female and male animals other than young ruminants for rearing, reared for milk production or reproduction, until entry in the reproduction period
Ruminants for milk production/reproduction
In all ruminant species, females which have mated or have been inseminated at least once, and adult males from entry in the reproduction period
Ruminants
All species and categories of ruminants
4. Food-producing aquatic animals
Species
Animal category
Definition of the animal category
Approximate weight/age in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
Food-producing finfish
Salmonids
200 -300 g
84 days
Food-producing finfish other than salmonids
All species of food-producing finfish other than salmonids
Food-producing finfish
All species of food-producing finfish
Food-producing molluscs
All species of food-producing molluscs
Food-producing crustaceans
All species of food-producing crustaceans
Other food-producing aquatic invertebrates
All species of other food-producing aquatic invertebrates
Food-producing aquatic animals
All species and categories of food-producing aquatic animals
5. Leporids ( Leporidae )
Species
Animal category
Definition of the animal category
Approximate weight/age in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
Rabbits
Growing rabbits
Females and males of:
—
kits getting milk from rabbit does, reared for reproduction or meat production from birth until weaning (suckling rabbits),
—
rabbits for fattening, from the end of the weaning period until slaughter,
—
young rabbits reared for reproduction, from the end of the weaning period until entry in the reproduction period
42 days
Rabbit does
Females for reproduction, which have mated or have been inseminated at least once
Two cycles, if the reproduction parameters are requested.
No later than from parturition until the end of the weaning period, if the application is in order to have benefit in kits.
Rabbit bucks
Males for reproduction, from entry in the reproduction period
Rabbits
All categories of rabbits
Leporids
Growing leporids
Females and males of:
—
leporid kits getting milk from leporid does, reared for reproduction or meat production from birth until weaning (suckling leporids),
—
leporids for fattening, from the end of the weaning period until slaughter,
—
young leporids reared for reproduction, from the end of the weaning period until entry in the reproduction period
Leporid does
Females for reproduction, which have mated or have been inseminated at least once
Leporid bucks
Males for reproduction, from entry in the reproduction period
Leporids
All species and categories of leporids
6. Equines ( Equidae )
Species
Animal category
Definition of the animal category
Approximate weight/age in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
Horses
Equines
All species of equines
7. Other food-producing animals
Species
Animal category
Definition of the animal category
Approximate duration period (weight/age) in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
Camelids
Camelid calves for fattening
In all camelid species, calves for meat production
Camelid calves for rearing
In all camelid species, calves reared for milk production/reproduction
Camelids for fattening
In all camelid species, animals for meat production other than calves for fattening
Camelids reared for milk production or reproduction
In all camelid species, young female and male animals other than calves for rearing, reared for milk production or reproduction, until entry in the reproduction period
Camelids for milk production or reproduction
In all camelid species, females which have mated or have been inseminated at least once and adult males
Camelids
All species and categories of camelids
Food-producing insects
Honeybees
28 days
Food-producing insect species other than honeybees
All food-producing insect species other than honeybees
Whole production cycle
Food-producing insects
All species of food-producing insects
Whole production cycle
Other food-producing animals
Only for species that are not covered in the previous entries. For example: snails, frogs, crocodiles …
8. Pets and other non-food-producing animals
Species
Animal category
Definition of the animal category
Approximate duration period (weight/age) in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
Pets
Dogs
28 days
Cats
28 days
Ornamental birds
28 days
Ornamental aquatic species
28 days
Other pets
Other pet species: ferrets, rodents, ornamental amphibian species, ornamental reptile species or ornamental terrestrial invertebrate species
28 days
Other non-food-producing animals
All species of non-food-producing animals, other than pets
28 days
Pets and other non-food-producing animals
All species of non-food-producing animals
28 days
9. All animal species
Species
Animal category
Definition of the animal category
Approximate duration period (weight/age) in the category
Minimum duration of long-term studies for efficacy
Period
Age
Weight
All terrestrial animal species
All aquatic animal species
All animal species
’
( x ) Note for guidance of the establishment of maximum residue limits for Salmonidae and other fin fish. The European Agency for the Evaluation of Medicinal Products. Veterinary Medicines Evaluation Unit. EMEA/CVMP/153b/97-FINAL.’;
( 1 ) For the functional groups 1(m) substances for reduction of the contamination of feed by mycotoxins, 1(n) hygiene condition enhancers, 1(o) other technological additives, 4(c) substances which favourably affect the environment, 4(d) other zootechnical additives, and 4(e) physiological condition stabilisers, it shall be necessary to define clearly, including in the public summary, which specific function is sought for the additive.
( 2 ) Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms ( OJ L 10, 16.1.2004, p. 5 , ELI: http://data.europa.eu/eli/reg/2004/65/oj ).
