Commission Implementing Regulation (EU) 2026/1115 of 26 May 2026 amending Regulation (EC) No 429/2008 as regards the application form for authorisations of feed additives and the designation of target animal species and categories

Image omitted; see official source	Official Journal of the European Union	EN L series
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	2026/1115	27.5.2026

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 nutrition [^ntr1-L_202601115EN.000101-E0001], 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 429/2008 [^ntr2-L_202601115EN.000101-E0002] 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 Authority [^ntr3-L_202601115EN.000101-E0003], 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 1

Amendments to Regulation (EC) No 429/2008

Regulation (EC) No 429/2008 is amended as follows:

• (1) Article 1 is replaced by the following:

‘Article 1

Definitions

The 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 2

Entry 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 26 May 2026.

For the Commission

The President

Ursula VON DER LEYEN

[^ntr1-L_202601115EN.000101-E0001]: OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.

[^ntr2-L_202601115EN.000101-E0002]: 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 (OJ L 133, 22.5.2008, p. 1, ELI: http://data.europa.eu/eli/reg/2008/429/oj).

[^ntr3-L_202601115EN.000101-E0003]: Guidance on the assessment of the efficacy of feed additives, EFSA Journal 2024;22:e8856. https://doi.org/10.2903/j.efsa.2024.8856.

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.

…

1. 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: …

1. Category/ies and functional group/s of additives [^ntr1-L_202601115EN.000402-E0001]

Category: …

Functional group: …

1. 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: …

1. Proposed mode of use in animal nutrition

☐ Use in feed

☐ Use in water for drinking

☐ Special conditions of use

1. 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 [^ntr2-L_202601115EN.000402-E0002] (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: …

1. Applicant’s EU representative contact details (as necessary)

EU Representative name: …

Email: …

Phone number: …

Website: …

Address: …

Post code: …

Country: …

1. 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: DT90 > 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 Kow. 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[^ntrx-L_202601115EN.000401-E0001] 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.

[^ntrx-L_202601115EN.000401-E0001]: 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.’;"

[^ntr-]: ()  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	Approximate weight/age in the category	Approximate weight/age in the category	Minimum duration of long-term efficacy studies
Animal species	Animal category	Definition of the animal category	Period/age	Age	Weight	Minimum duration of long-term efficacy studies
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
Pigs	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
Pigs	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	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	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
Pigs	Sows	Females for reproduction, which have mated or have been inseminated at least once				Two full reproduction cycles
Pigs	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)
Pigs	Boars	Males for reproduction, from entry in the reproduction period
Pigs	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
Minor porcine species	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)
Minor porcine species	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	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	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
Minor porcine species	Sows of minor porcine species	Females of all minor porcine species for reproduction, which have mated or have been inseminated at least once
Minor porcine species	Boars of minor porcine species	Males of all minor porcine species for reproduction, from entry in the reproduction period
Minor porcine species	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
Porcine species	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)
Porcine species	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	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	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
Porcine species	Sows of porcine species	Females of all porcine species for reproduction, which have mated or have been inseminated at least once
Porcine species	Boars of porcine species	Males of all porcine species for reproduction, from entry in the reproduction period
Porcine species	Porcine species	All species and categories of all porcine species

1. Poultry

Species	Animal category	Definition of the animal category	Approximate weight/age in the category	Approximate weight/age in the category	Approximate weight/age in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
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	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)
Chickens	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
Chickens	Roosters	Roosters, from entry in the reproduction period
Chickens	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	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	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	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	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	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	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	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	Poultry for laying or reproduction	Females and males of all poultry species, from entry in the laying (consumer egg production) or reproduction period
Poultry	Poultry	All species and categories of poultry

1. Ruminants

Species	Animal category	Definition of the animal category	Approximate weight/age in the category	Approximate weight/age in the category	Approximate weight/age in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
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
Cattle	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	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	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
Cattle	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.
Cattle	Bulls	Bulls for reproduction, from entry in the reproduction period
Cattle	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
Minor bovine species	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 bovine species	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 bovine species	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
Minor bovine species	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
Minor bovine species	Bulls of minor bovine species	In all minor bovine species, bulls for reproduction, from entry in the reproduction period
Minor bovine species	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
Bovines	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	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	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
Bovines	Cows of bovine species	In all bovine species, cows for milk production/reproduction, which have mated or have been inseminated at least once
Bovines	Bulls of bovine species	In all bovine species, bulls for reproduction, from entry in the reproduction period
Bovines	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
Sheep	Lambs for rearing	Lambs reared for milk production/reproduction, from birth up to 3 months			15 -20  kg	56 days
Sheep	Sheep for fattening	Sheep for meat production other than lambs for fattening, until date of slaughter
Sheep	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
Sheep	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.
Sheep	Rams	Rams for reproduction, from entry in the reproduction period
Sheep	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
Ovines	Lambs of ovine species for rearing	In all ovine species, lambs reared for milk production/reproduction, from birth up to 3 months
Ovines	Ovines for fattening	In all ovine species, ovines for meat production other than lambs for fattening, until date of slaughter
Ovines	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
Ovines	Ewes of ovine species	In all ovine species, ewes for milk production/reproduction, which have mated or have been inseminated at least once
Ovines	Rams of ovine species	In all ovine species, rams for reproduction, from entry in the reproduction period
Ovines	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
Goats	Kids for rearing	Kids reared for milk production/reproduction, from birth up to 3 months			15 -20  kg	56 days
Goats	Goats for fattening	Goats for meat production other than kids for fattening, until date of slaughter
Goats	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
Goats	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.
Goats	Goat bucks	Bucks (billy goats) for reproduction, from entry in the reproduction period
Goats	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
Caprines	Kids of caprine species for rearing	In all caprine species, kids reared for milk production/reproduction), from birth up to 3 months
Caprines	Caprines for fattening	In all caprine species, caprines for meat production other than kids for fattening, until date of slaughter
Caprines	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
Caprines	Does of caprine species	In all caprine species, female goats for milk production/reproduction, which have mated or have been inseminated at least once
Caprines	Bucks of caprine species	In all caprine species, bucks for reproduction, from entry in the reproduction period
Caprines	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
Ruminants	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	Ruminants for fattening	In all ruminant species, animals for meat production other than young ruminants for fattening, until date of slaughter
Ruminants	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	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	Ruminants	All species and categories of ruminants

1. Food-producing aquatic animals

Species	Animal category	Definition of the animal category	Approximate weight/age in the category	Approximate weight/age in the category	Approximate weight/age in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
Food-producing finfish	Salmonids				200 -300  g	84 days
Food-producing finfish	Food-producing finfish other than salmonids	All species of food-producing finfish other than salmonids
Food-producing finfish	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

1. Leporids (Leporidae)

Species	Animal category	Definition of the animal category	Approximate weight/age in the category	Approximate weight/age in the category	Approximate weight/age in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
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
Rabbits	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.
Rabbits	Rabbit bucks	Males for reproduction, from entry in the reproduction period
Rabbits	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
Leporids	Leporid does	Females for reproduction, which have mated or have been inseminated at least once
Leporids	Leporid bucks	Males for reproduction, from entry in the reproduction period
Leporids	Leporids	All species and categories of leporids

1. Equines (Equidae)

Species	Animal category	Definition of the animal category	Approximate weight/age in the category	Approximate weight/age in the category	Approximate weight/age in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
Horses
Equines		All species of equines

1. Other food-producing animals

Species	Animal category	Definition of the animal category	Approximate duration period (weight/age) in the category	Approximate duration period (weight/age) in the category	Approximate duration period (weight/age) in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
Camelids	Camelid calves for fattening	In all camelid species, calves for meat production
Camelids	Camelid calves for rearing	In all camelid species, calves reared for milk production/reproduction
Camelids	Camelids for fattening	In all camelid species, animals for meat production other than calves for fattening
Camelids	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	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	Camelids	All species and categories of camelids
Food-producing insects	Honeybees					28 days
Food-producing insects	Food-producing insect species other than honeybees	All food-producing insect species other than honeybees				Whole production cycle
Food-producing insects	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 …

1. Pets and other non-food-producing animals

Species	Animal category	Definition of the animal category	Approximate duration period (weight/age) in the category	Approximate duration period (weight/age) in the category	Approximate duration period (weight/age) in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
Pets	Dogs					28 days
Pets	Cats					28 days
Pets	Ornamental birds					28 days
Pets	Ornamental aquatic species					28 days
Pets	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

1. All animal species

Species	Animal category	Definition of the animal category	Approximate duration period (weight/age) in the category	Approximate duration period (weight/age) in the category	Approximate duration period (weight/age) in the category	Minimum duration of long-term studies for efficacy
Species	Animal category	Definition of the animal category	Period	Age	Weight	Minimum duration of long-term studies for efficacy
All terrestrial animal species
All aquatic animal species
All animal species

’

[^ntcx-L_202601115EN.000401-E0001]  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.’;

[^ntr1-L_202601115EN.000402-E0001]: 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.

[^ntr2-L_202601115EN.000402-E0002]: 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).

ANNEX II

The following Annex V is added to Regulation (EC) No 429/2008:

‘

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

Bovine, ovine and caprine and cervid animals, as defined below.

• (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.

4. Food-producing aquatic animals

Animals of the species within the following:

• (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;

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

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:

• (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,

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

In accordance with the definition set out in Article 1(1), pets and non-food-producing animals include the following species:

• (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;

• 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;

• 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.

• (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.

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

Animals of:

• (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.

’

ANNEX III

CONCORDANCE TABLE OF ANIMAL SPECIES AND CATEGORIES