Contents
- THE EUROPEAN COMMISSION, Having regard to the Treaty on th…
- 1 Amendments to Regulation (EC) No 429/2008
- 2 Entry into force and application
- I Application form referred to in article 2(1)
- II
- III Concordance table of animal species and categories
- IV Designation of the target animal categories and minimum duration of the long-term efficacy studies
- V Definition of respective animal species and differentiation between major and minor species as regards food-producing animal species
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutritionnote, and in particular Article 7(4), first subparagraph, and Article 7(5), first subparagraph, thereof,After consulting the European Food Safety Authority,Whereas:
(1)Regulation (EC) No 1831/2003 establishes the procedure for authorising the placing on the market and use of feed additives. It provides that any person seeking an authorisation for a feed additive, or a new use of a feed additive is to submit an application for authorisation to the Commission in accordance with that Regulation.
(2)Commission Regulation (EC) No 429/2008note sets out detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications for the authorisation of feed additives and the assessment of such applications. Annex I to Regulation (EC) No 429/2008 sets out the form that must be used to submit an application for the authorisation of a feed additive, and Annex IV to that Regulation lays down target animals’ categories and their respective definitions and indicates the minimum duration of the related efficacy studies.
(3)The application form set out in Annex I to Regulation (EC) No 429/2008 was established at a time when applications for the authorisation of feed additives were submitted as physical or scanned documents. Since 2021, all applications for feed additives must be submitted via the electronic submission system of the Commission. That evolution would allow the system to have an automatically generated application form, by extracting the necessary information from the electronic submission. In addition, the content of the application form should be simplified with a view to optimise the treatment of applications.
(4)The experience accumulated by the Commission, the European Food Safety Authority (‘the Authority’) and the Standing Committee on Plants, Animals, Food and Feed in processing applications for authorisation of feed additives has shown the need to update the terminology used in Annex IV to Regulation (EC) No 429/2008 for designating the animal species and categories subject to a particular application, while also ensuring that Annex IV covers all possible animal species and categories which are bred or kept in the Union and not just the main food-producing animal species and categories. Such approach would give clarity as to the concrete scope of the applications and facilitate the authorisation process. Article 1(2), Article 3(2), last subparagraph, of Regulation (EC) No 429/2008 and Annexes II, III and IV thereto should therefore be amended accordingly.
(5)The minimum duration of long-term efficacy studies laid down in point 4.4, fourth subparagraph of Annex II to Regulation (EC) No 429/2008 and in the last column of Annex IV to that Regulation was set out in 2008. That minimum duration should be adjusted in accordance with the latest recommendations of the Authoritynote, which reflect the recent technological progress and scientific developments and advise for a shorter minimum duration of long-term efficacy studies for some animal species and categories such as laying hens or salmon and trout.
(6)The definition of ‘minor species’ laid down in Article 1(2) of Regulation (EC) No 429/2008 should be complemented for more clarity by introducing a definition of ‘major species’.
(7)A new Annex V should be added to that Regulation on definitions of the respective animal species and the differentiation between the major and minor species, comprised therein. In addition, it should be made clear in the new Annex V to that Regulation that rabbits and horses that are not used for human consumption do not belong to the group of pets and non-food-producing animals but to the group of leporids (Leporidae) and equines (Equidae) respectively.
(8)A concordance table should be provided in Annex III to this Implementing Regulation, offering a correspondence between the terms commonly used for the designation of animal species and categories in the authorisations of feed additives granted before the date of application of this Implementing Regulation and the terms designating the same animal species and categories to be used as of the date of application of this Implementing Regulation. The objective of that concordance table is to assist applicants in designating the relevant scope of target animal species, when preparing applications in accordance with Article 13 and Article 14 of Regulation (EC) No 1831/2003 for the modification or the renewal of existing authorisations, to be submitted as of the date of application of this Implementing Regulation.
(9)Regulation (EC) No 429/2008 should therefore be amended accordingly.
(10)In order to enable business operators to adapt to the new requirements set by this Implementing Regulation, it is necessary that this Regulation starts applying 6 months after its date of entry into force.
(11)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1Amendments to Regulation (EC) No 429/2008#
Regulation (EC) No 429/2008 is amended as follows:
(1)Article 1 is replaced by the following:‘Article 1DefinitionsThe following definitions shall apply for the purpose of this Regulation:
(1)“pets and other non-food producing animals” means animals belonging to species normally fed, bred or kept, but not consumed by humans, as detailed in point 8 of Annex V;
(2)“major species” means animal species normally used for human consumption in the Union as detailed in points 1 to 4 of Annex V;
(3)“minor species” means animal species normally used for human consumption in the Union as detailed in points 1 to 7 of Annex V.’
;
(2)Article 2(1), first subparagraph, is replaced by the following:‘1.An application for the authorisation of a feed additive, as provided for in Article 7 of Regulation (EC) No 1831/2003, shall be submitted to the Commission via the electronic submission system of the Commission. Once the application is submitted in the electronic system, the applicant, the Commission, the Authority and the Member States shall have access to the application form as set out in Annex I.’;
(3)Article 3(2), third subparagraph, is replaced by the following:‘The terminology to be used for designating the target animal species and categories, as well as the minimum duration of long-term efficacy studies shall be as set out in Annex IV.The definitions of the respective animal species shall be set out in Annex V.’;
(4)Annexes I, II, III and IV to Regulation (EC) No 429/2008 are amended in accordance with Annex I to this Implementing Regulation.
(5)A new Annex V is added to Regulation (EC) No 429/2008 in accordance with Annex II to this Implementing Regulation.
Article 2Entry into force and application#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 16 December 2026.
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
☐Substance
☐Micro-organism
☐Preparation
Additive type(s) to be placed on the market:
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 additivesFor 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.
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
☐Yes
☐Yes
☐No
☐No
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 65/2004note (where appropriate): …
Has any authorisation been granted in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council?
Is there any pending application for authorisation under Regulation (EC) No 1829/2003 of the European Parliament and of the Council?
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: …
Annex II
The following Annex V is added to Regulation (EC) No 429/2008:
‘’
III · Concordance table of animal species and categories
| Terms commonly used for the designation of animal species and categories in authorisations granted before 16 December 2026 | Terms designating the corresponding animal species and categories in accordance with this Implementing Regulation (alternatives may be considered appropriate on a case-by-case basis)[Animal species/category (additional precision)] |
|---|---|
| All animal species | All animal species |
| All avian species | Poultry + Ornamental birds |
| All avian species for fattening | Poultry for fattening |
| All avian species for laying | Poultry for laying or reproduction |
| All avian species reared for breeding | Poultry reared for laying or reproduction |
| All avian species reared for laying | Poultry reared for laying or reproduction |
| All crustaceans | Food-producing crustaceans + Ornamental aquatic species (crustaceans) |
| All fin fish | Food-producing finfish + Ornamental aquatic species (finfish) |
| All fish | Food-producing finfish + Ornamental aquatic species (finfish) |
| All laying poultry | Poultry for laying or reproduction |
| All minor avian species for fattening | Minor poultry for fattening |
| All minor avian species reared for laying | Minor poultry reared for laying or reproduction |
| All minor porcine species | Minor porcine species |
| All minor poultry species for laying | Minor poultry for laying or reproduction |
| All minor ruminant species for rearing | Calves of minor bovine species for rearing + Minor bovines reared for milk production/reproduction + Lambs of ovine species for rearing + Ovines reared for milk production/reproduction + Kids of caprine species for rearing + Caprines reared for milk production/reproduction + Cervids (animals for rearing) |
| All minor ruminant species for fattening | Calves of minor bovine species for fattening + Minor bovines for fattening + Lambs of ovine species for fattening (except sheep) + Ovines for fattening (except sheep) + Kids of caprine species for fattening + Caprines for fattening + Cervids (animals for fattening) |
| All pigs | Pigs |
| All porcine species | Porcine species |
| All porcine species weaned | Weaned piglets of porcine species |
| All porcine species for breeding | Sows of porcine species + Boars of porcine species |
| All poultry | Poultry |
| All poultry species | Poultry |
| All poultry species for fattening | Poultry for fattening |
| All poultry species for laying | Poultry for laying or reproduction |
| All poultry species reared for breeding | Poultry reared for laying or reproduction |
| All poultry species reared for laying | Poultry reared for laying or reproduction |
| All species | All animal species |
| All species or categories of animals | All animal species |
| All Suidae | Porcine species |
| All Suidae for fattening | Porcine species for fattening |
| All Suidae for reproduction purposes | Sows of porcine species + Boars of porcine species |
| All turkeys | Turkeys |
| Aquatic animals | All aquatic animal species |
| Bovines | Bovines |
| Breeder hens | Hens |
| Breeding hens | Hens |
| Calves | Calves for fattening + Calves for rearing |
| Calves (milk replacer) | Calves for fattening + Calves for rearing |
| Calves for fattening | Calves for fattening |
| Calves for rearing | Calves for rearing |
| Camelids for rearing | Camelid calves for rearing + Camelids reared for milk production or reproduction |
| Camelids for fattening | Camelid for fattening |
| Canaries | Ornamental birds (canaries) |
| Canidae | Dogs + Other non-food-producing animals (Canidae) |
| Carp | Food-producing finfish other than salmonids (carp) |
| Cats | Cats |
| Cattle | Cattle |
| Cattle for fattening | Cattle for fattening |
| Chickens | Chickens |
| Chickens for fattening | Chickens for fattening |
| Chickens reared for breeding | Chickens reared for laying or reproduction |
| Chickens reared for laying | Chickens reared for laying or reproduction |
| Cows for reproduction | Cows + Cattle reared for milk production/reproduction |
| Crustaceans | Food-producing crustaceans + Ornamental aquatic species (crustaceans) |
| Dairy buffaloes | Cows of minor bovine species (buffaloes) |
| Dairy cows | Cows |
| Dairy cows of minor bovine species | Cows of minor bovine species |
| Dairy goats | Goat does |
| Dairy ruminants | Ruminants for milk production/reproduction |
| Dairy sheep | Ewes |
| Dogs | Dogs |
| Ducks | Minor poultry (ducks) |
| Ducks for fattening | Minor poultry for fattening (ducks) |
| Equidae | Equines |
| Fattening Suidae | Porcine species for fattening |
| Felidae | Cats + Other non-food-producing animals (Felidae) |
| Finfish | Food-producing finfish + Ornamental aquatic species (finfish) |
| Fish | Food-producing finfish + Ornamental aquatic species (finfish) |
| Fish species | Food-producing finfish + Ornamental aquatic species (finfish) |
| Food-producing animals | Porcine species + Poultry + Ruminants + Food-producing aquatic animals + Leporids + Equines + Other food producing animals |
| Game birds | Minor poultry (target bird species to be detailed) |
| Goats | Goats |
| Goats for fattening | Goats for fattening |
| Grain-eating ornamental birds | Ornamental birds (grain-eating birds) |
| Guinea fowl | Minor poultry (Guinea fowls (Numida meleagris)) |
| Guinea fowl for breeding | Minor poultry for laying or reproduction (Guinea fowls (Numida meleagris)) |
| Guinea fowl for fattening | Minor poultry for fattening (Guinea fowls (Numida meleagris)) |
| Guinea pigs | Other pets (Guinea pigs) |
| Horses | Horses |
| Kids | Kids for fattening + Kids for rearing |
| Kids for fattening | Kids for fattening |
| Kids for rearing | Kids for rearing |
| Lactating sows | Sows |
| Lactating sows of all Suidae species | Sows of porcine species |
| Lagomorphs | Leporids |
| Lambs | Lambs for fattening + Lambs for rearing |
| Lambs for fattening | Lambs for fattening |
| Lambs for rearing | Lambs for rearing |
| Laying birds | Poultry for laying or reproduction |
| Laying hens | Hens |
| Laying poultry | Poultry for laying or reproduction |
| Mammals | Porcine species + Ruminants + Leporids + Equines + Camelids + Dogs + Cats + Other pets (Mammals) + Other non-food-producing animals (Mammals) |
| Marine animals | Food-producing aquatic animals (marine animals) + Other pets (marine animals) + Other non-food-producing animals (marine animals) |
| Minor avian species | Minor poultry |
| Minor avian species for fattening | Minor poultry for fattening |
| Minor avian species for laying | Minor poultry for laying or reproduction |
| Minor avian species reared for laying | Minor poultry reared for laying or reproduction |
| Minor dairy ruminant species | Cows of minor bovine species + Minor bovines reared for milk production/reproduction + Ewes of ovine species + Ovines reared for milk production/reproduction + Does of caprine species + Caprines reared for milk production/reproduction |
| Minor finfish | Food-producing finfish other than salmonids |
| Minor porcine species (suckling and weaned) | Piglets of minor porcine species |
| Minor porcine species (suckling piglets) | Suckling piglets of minor porcine species |
| Minor porcine species (weaned) | Weaned piglets of minor porcine species |
| Minor porcine species for fattening | Minor porcine species for fattening |
| Minor porcine species for reproduction | Sows of minor porcine species + Boars of minor porcine species |
| Minor poultry for fattening | Minor poultry for fattening |
| Minor poultry for laying | Minor poultry for laying or reproduction |
| Minor poultry species | Minor poultry |
| Minor poultry species for breeding | Minor poultry for laying or reproduction |
| Minor poultry species for fattening | Minor poultry for fattening |
| Minor poultry species for laying | Minor poultry for laying or reproduction |
| Minor poultry species reared for breeding | Minor poultry reared for laying or reproduction |
| Minor poultry species reared for laying | Minor poultry reared for laying or reproduction |
| Minor ruminant species for fattening | Calves of minor bovine species for fattening + Minor bovines for fattening + Lambs of ovine species for fattening (except sheep) + Ovines for fattening (except sheep) + Kids of caprine species for fattening + Caprines for fattening + Cervids (animals for fattening) |
| Minor ruminant species for rearing | Calves of minor bovine species for rearing + Minor bovines reared for milk production/reproduction + Lambs of ovine species for rearing + Ovines reared for milk production/reproduction + Kids of caprine species for rearing + Caprines reared for milk production/reproduction + Cervids (animals for rearing) |
| Minor ruminants for dairy production | Cows of minor bovine species + Minor bovines reared for milk production/reproduction + Ewes of ovine species + Ovines reared for milk production/reproduction + Does of caprine species + Caprines reared for milk production/reproduction |
| Minor ruminants for fattening | Calves of minor bovine species for fattening + Minor bovines for fattening + Lambs of ovine species for fattening (except sheep) + Ovines for fattening (except sheep) + Kids of caprine species for fattening + Caprines for fattening + Cervids (animals for fattening) |
| Mustelidae | Other pets (ferrets) + Other non-food-producing animals (Mustelidae) |
| Non-food-producing animals | Pets and other non-food-producing animals |
| Ornamental birds | Ornamental birds |
| Ornamental fish | Ornamental aquatic species |
| Ovines | Ovines |
| Partridges | Minor poultry (partridges) |
| Pets | Dogs + Cats + Ornamental birds + Ornamental aquatic species + Other pets |
| Pheasants | Minor poultry (pheasants) |
| Piglets | Piglets |
| Piglets (suckling and weaned) | Piglets |
| Piglets (weaned) | Weaned piglets |
| Piglets of all Suidae species | Piglets of porcine species |
| Piglets of minor porcine species | Piglets of minor porcine species |
| Piglets of minor porcine species (suckling and weaned) | Piglets of minor porcine species |
| Piglets of minor Suidae | Piglets of minor porcine species |
| Pigs | Pigs |
| Pigs for fattening | Pigs for fattening |
| Pigs for fattening of all Suidae species | Porcine species for fattening |
| Pigs for fattening of minor Suidae | Minor porcine species for fattening |
| Porcine species (suckling and weaned) | Piglets of porcine species |
| Poultry | Poultry |
| Poultry for breeding | Poultry for laying or reproduction |
| Poultry for fattening | Poultry for fattening |
| Poultry for laying | Poultry for laying or reproduction |
| Poultry reared for breeding | Poultry reared for laying or reproduction |
| Poultry reared for laying | Poultry reared for laying or reproduction |
| Poultry species for fattening | Poultry for fattening |
| Poultry species for laying | Poultry reared for laying or reproduction |
| Quails | Minor poultry (quails) |
| Rabbits | Rabbits |
| Rabbits for fattening | Growing rabbits |
| Reptiles | Other food producing animals (reptiles) + Other pets (reptiles) |
| Rodents | Other pets (rodents) |
| Ruminants | Ruminants |
| Ruminants for fattening | Young ruminants for fattening + Ruminants for fattening |
| Ruminants with a functional rumen | Ruminants (with a functional rumen) |
| Ruminants with a non-functional rumen | Ruminants (with a non-functional rumen) |
| Salmon | Salmonids (salmons) |
| Salmonids | Salmonids |
| Sheep | Sheep |
| Sheep for fattening | Sheep for fattening |
| Sows | Sows |
| Sows for reproduction | Sows |
| Sows of all Suidae species | Sows of porcine species |
| Sows, in order to have benefit in piglets | Sows, in order to have benefit in piglets |
| Suckling piglets | Suckling piglets |
| Suckling piglets of all Suidae species | Suckling piglets of porcine species |
| Suckling rabbits | Growing rabbits |
| Suckling Suidae piglets | Suckling piglets of porcine species |
| Trout | Salmonids (trout) |
| Turkeys | Turkeys |
| Turkeys for fattening | Turkeys for fattening |
| Turkeys reared for breeding | Turkeys reared for reproduction |
| Weaned minor porcine species | Weaned piglets of minor porcine species |
| Weaned piglets | Weaned piglets |
| Weaned piglets of all Suidae | Weaned piglets of porcine species |
| Weaned piglets of minor porcine species | Weaned piglets of minor porcine species |
| Weaned Suidae | Weaned piglets of porcine species |
| Weaned Suidae piglets | Weaned piglets of porcine species |
| Zoo mammals | Other non-food-producing animals (zoo mammals) |
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 days35 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 ~1600 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 1200 g (white)1400 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 ~7000 g (up to 10000 g) Cocks: up to~12000 g(up to 20000 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~15000 gCocks: up to~30000 g | |||
| Turkeys for reproduction | Female and male birds held for breeding purposes | From 30 weeks up to~ 60 weeks | Hens: from~15000 gCocks: from~30000 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 daysTwo 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 daysTwo 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 daysTwo 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 |
Annex V · Definition of respective animal species and differentiation between major and minor species as regards food-producing animal species
1. Porcine species (Suidae)
Animals of species within the family Suidae genus Babyrousa ssp., Hylochoerus ssp., Phacochoerus ssp., Porcula ssp., Potamochoerus ssp. and Sus ssp., and the offsprings of the crossing of those species, which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.
Major species: pigs (Sus scrofa domesticus).
Minor species: porcine species, other than pigs (Sus scrofa domesticus).
2. Poultry
Birds of species which are fed, bred or kept for the production of food for human consumption, including restocking supplies of game birds, and including birds that are not used for the production of food for human consumption but belong to species which are normally used for human consumption in the Union.
Major species: chickens (including laying hens) (Gallus gallus domesticus) and turkeys (Meleagris gallopavo).
Minor species: poultry, other than chickens and turkeys, including quails (e.g. Coturnix japonica, Coturnix coturnix), ducks (e.g. Anas platyrhynchos, Cairina moschata), geese (e.g. Anser anser), Guinea fowls (Numida meleagris), pigeons (e.g. Columba livia domestica), pheasants (e.g. Phasianus colchicus), Indian peafowls (Pavo cristatus), partridges (e.g. Perdix perdix, Alectoris rufa), ratites including ostrich (Struthio sp.), emu (Dromaius novaehollandiae), rhea (Rhea sp.).
3. Ruminants
(a)Bovines: animals of species of ungulates within the genus Bison, Bos (including the subgenus Bos, Bibos, Novibos, Poephagus) and Bubalus (including the subgenus Anoa), and the offsprings of the crossing of those species, which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.Major species: cattle (Bos taurus).Minor species: all bovines other than cattle (Bos taurus), including buffalo (Bubalus bubalis) and bison (Bison bison).
(b)Ovines: animals of species of ungulates within the genus Ovis, and the offsprings of the crossing of those species, which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.Major species: sheep (Ovis aries) for meat production (meat animals).Minor species: ovines other than sheep (Ovis aries) for meat production.
(c)Caprines: animals of the species of ungulates within the genus Capra, and the offsprings of the crossing of those species, which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.Minor species: all caprines.
(d)Cervids (Cervidae): animals of the species of ungulates within the family Cervidae, and the offsprings of the crossing of those species, which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.Minor species: all cervids.
Bovine, ovine and caprine and cervid animals, as defined below.
4. Food-producing aquatic animals
(a)finfish, belonging to the classes Chondrichthyes, Sarcopterygii, Actinopterygii, and Hyperoartia;
(b)aquatic molluscs, belonging to the phylum Mollusca;
(c)aquatic crustaceans, belonging to the subphylum Crustacea;
(d)other aquatic invertebrates;
Animals of the species within the following:
which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.
Major species: salmonids (Salmonidae), including salmon (Salmo) and trout (Oncorhynchus).
Minor species: all food-producing aquatic animals other than salmonids.
5. Leporids (Leporidae)
Animals of species within the family Leporidae which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.
Minor species: all leporids, including rabbits (Oryctolagus cuniculus) and hares (Lepus europaeus).
6. Equines (Equidae)
Animals of species within the genus Equus, and the offspring of crossings of those species, which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.
Minor species: all equines, including horses (Equus caballus) and asses (Equus asinus).
7. Other food-producing animals
(a)Camelids (Camelidae): animals, belonging to the family Camelidae, including dromedary camels (Camelus dromedarius), Bactrian camels (Camelus bactrianus), wild Bactrian camels (Camelus ferus), llamas (Lama glama), alpacas (Lama pacos), vicuñas (Lama vicugna) and guanacos (Lama guanicoe),
(b)Honeybees (Apis mellifera),
(c)Food-producing insect species, other than honeybees,
(d)Other food-producing animals,
Animals of species, other than porcine species, poultry, ruminants, food-producing aquatic species, leporids and equines as defined above, and the offsprings of the crossing of those species, within the following:
which are fed, bred or kept for the production of food for human consumption, including animals that are not used for human consumption but belong to the species which, among the above-mentioned group of species, are normally used for human consumption in the Union.
Minor species: all species of other food-producing animals.
8. Pets and other non-food-producing animals
(a)Pets:
i.Dogs (Canis lupus familiaris);
ii.Cats (Felis silvestris catus);
iii.Ferrets (Mustela putoris furo);
iv.Rodents: animals belonging to the order Rodentia;
ix.Ornamental terrestrial invertebrate species: terrestrial invertebrate species other than those listed in “other food-producing animals” and other than those that are normally used for human consumption in the Union.
v.Ornamental birds: avian species other than poultry, including wild birds;
vi.Ornamental aquatic species: aquatic species other than those listed in “food-producing aquatic animals”;
vii.Ornamental amphibian species: amphibian species other than those that are normally used for human consumption in the Union;
viii.Ornamental reptile species: reptile species other than those that are normally used for human consumption in the Union;
(b)Other non-food-producing animals:
x.Fur animals (mink, fox, racoon);
xi.Other, including zoo, circus and laboratory animals, other than those belonging to species normally used for human consumption in the Union.
In accordance with the definition set out in Article 1(1), pets and non-food-producing animals include the following species:
Rabbits and horses, including animals that are not used for human consumption, do not belong to the group of pets and non-food-producing animals but to that of leporids (Leporidae) and equines (Equidae), respectively.
9. All animal species
(a)all terrestrial animal species: porcine species, poultry, ruminants, leporids, equines, other food-producing animals, pets and other non-food-producing animals except ornamental aquatic species;
(b)all aquatic animal species: food-producing aquatic animals and ornamental aquatic species.
Animals of:
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.