Regulation 2019/4 - Manufacture, placing on the market and use of medicated feed - Main contents

EN

Official Journal of the European Union

L 4/1

Council Directive 90/167/EEC (3) constitutes the Union’s regulatory framework for the preparation, placing on the market and use of medicated feed.

Livestock production occupies a very important place in the agriculture of the Union. The rules concerning medicated feed have a significant influence on the keeping and on the rearing of animals, including non-food-producing animals, and on the production of products of animal origin.

The pursuit of a high level of protection of human health is one of the fundamental objectives of Union food law, as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council (4), and the general principles laid down in that Regulation should apply to the placing on the market and use of feed without prejudice to more specific Union legislation. In addition, the protection of animal health constitutes one of the general objectives of Union food law.

Prevention of disease is better than cure. Medicinal treatments, especially with antimicrobials, should never replace good husbandry, bio-security and management practices.

Experience with the application of Directive 90/167/EEC has shown that further measures should be taken to strengthen the effective functioning of the internal market and to explicitly give and improve the possibility to treat non-food-producing animals with medicated feed.

Medicated feed is one of the routes for the oral administration of veterinary medicinal products. Medicated feed is a homogeneous mixture of feed and veterinary medicinal products. Other routes for oral administration, such as mixing of water for drinking with a veterinary medicinal product or manual mixing of a veterinary medicinal product into feed should not fall within the scope of this Regulation. The authorisation for use in feed, the manufacture, distribution, advertising and supervision of those veterinary medicinal products are governed by Regulation (EU) 2019/6 of the European Parliament and of the Council (5).

Regulation (EU) 2019/6 applies to veterinary medicinal products, including those products which Directive 90/167/EEC referred to as ‘pre-mixes’, until such time as those products are included in medicated feed or intermediate products, after which this Regulation applies to the exclusion of Regulation (EU) 2019/6.

As a type of feed, medicated feed and intermediate products fall within the scope of Regulations (EC) No 183/2005 (6), (EC) No 767/2009 (7), (EC) No 1831/2003 (8) and Directive 2002/32/EC (9) of the European Parliament and of the Council. Thus, whenever medicated feed is manufactured with a compound feed all relevant Union legislation on compound feed applies and whenever medicated feed is manufactured from a feed material, all relevant Union legislation on feed material applies. This applies to feed business operators, whether they operate in a feed mill, with a specially equipped vehicle or on-farm, as well as to feed business operators storing, transporting or placing on the market medicated feed and intermediate products.

Specific provisions for medicated feed and intermediate products should be established concerning facilities and equipment, personnel, manufacture, quality control, storage, transport, record-keeping, complaints, product recalls and labelling.

Medicated feed imported into the Union must satisfy the general obligations laid down in Article 11 of Regulation (EC) No 178/2002 and the import conditions laid down in Regulation (EC) No 183/2005 and in Regulation (EU) 2017/625 of the European Parliament and of the Council (10). Within that framework, medicated feed imported into the Union should be considered as falling within the scope of this Regulation.

Without prejudice to the general obligations laid down in Article 12 of Regulation (EC) No 178/2002 concerning exports of feed to third countries, this Regulation should apply to medicated feed and intermediate products which are manufactured, stored, transported or placed on the market within the Union with the intention to be exported. However, the specific requirements concerning labelling, prescription and use of medicated feed and intermediate products, laid down in this Regulation, should not apply to products intended to be exported.

While veterinary medicinal products and the supply thereof are covered by Regulation (EU) 2019/6, intermediate products are not and should therefore be specifically covered by this Regulation in a corresponding way.

Medicated feed should be manufactured only with veterinary medicinal products authorised for the purpose of the manufacture of medicated feed and the compatibility of all compounds used should be ensured for the purpose of safety and efficacy of the product. Additional specific requirements or instructions for the inclusion of the veterinary medicinal products into feed should be provided for to ensure safe and efficient treatment of the animals.

Homogeneous dispersion of the veterinary medicinal product into the feed is also crucial for the manufacture of a safe and efficient medicated feed. Therefore, the possibility to establish criteria, such as target values, for the homogeneity of the medicated feed should be provided for.

Feed business operators may manufacture within one establishment a broad range of feeds for different target animals and containing different types of compounds such as feed additives or veterinary medicinal products. The manufacture of different types of feed after each other in the same production line may result in the presence of traces of an active substance in the line, which ends up in the beginning of the production of another feed. That transfer of traces of an active substance from one production batch to another is called ‘cross-contamination’.

Cross-contamination may occur during manufacture, processing, storage or transport of feed where the same production and processing equipment, including for mobile mixing, storage facilities or means of transport are used for feed with different components. For the purposes of this Regulation, the concept of cross-contamination is used specifically to designate the transfer of traces of an active substance contained in a medicated feed to a non-target feed. Contamination of non-target feed with active substances contained in medicated feed should be avoided or kept as low as possible.

In order to protect animal health, human health and the environment, maximum levels of cross-contamination for active substances in non-target feed should be established, based on a scientific risk assessment performed by the European Food Safety Authority (EFSA) and in cooperation with the European Medicines Agency, as well as taking into account the application of good manufacturing practice and the ‘as low as reasonably achievable’ (‘ALARA’) principle. Until the completion of that scientific risk assessment, national maximum levels of cross-contamination for active substances in non-target feed, regardless of its origin, should apply, taking into account the unavoidable cross-contamination and the risk caused by the active substances concerned.

Labelling of medicated feed should comply with the general principles laid down in Regulation (EC) No 767/2009 and should be subject to specific labelling requirements in order to provide the user with the information necessary to correctly administer the medicated feed. Similarly, limits for the deviations of the labelled content of medicated feed from the actual content should be established.

Medicated feed and intermediate products should be marketed in sealed packages or containers for safety reasons and to protect users’ interests. This should not apply to mobile mixers that supply medicated feed directly to the animal keeper.

The advertising of medicated feed could affect public and animal health and distort competition. Therefore, advertising of medicated feed should satisfy certain criteria. Veterinarians can properly evaluate the information available in advertising because of their knowledge and experience in animal health. The advertising of medicated feed to persons who cannot properly appreciate the risk associated with their use may lead to medicine misuse or overconsumption which is liable to harm public or animal health, or the environment.

For intra-Union trade and import of medicated feed, it should be ensured that the veterinary medicinal products contained therein are allowed for use in the destination Member State in accordance with Regulation (EU) 2019/6.

It is important to take into consideration the international dimension of the development of antimicrobial resistance. Antimicrobial resistant organisms can spread to humans and animals in the Union and third countries through consumption of products of animal origin, from direct contact with animals or humans or by other means. This has been recognised in Article 118 of Regulation 2019/6 which provides that operators in third countries are to respect certain conditions relating to antimicrobial resistance for animals and products of animal origin exported from such third countries to the Union. This is to be taken into consideration also in respect of the use of antimicrobial medicinal products concerned if they are administered via medicated feed. Furthermore, in the context of international cooperation and in line with the activities and policies of international organisations such as the World Health Organization (WHO) Global Action Plan and the Strategy on Antimicrobial Resistance and the Prudent use of Antimicrobials of the World Organisation for Animal Health, steps restricting the use of medicated feed containing antimicrobials in order to prevent a disease should be considered worldwide for animals and products of animal origin exported from third countries to the Union.

Feed business operators manufacturing – whether they operate in a feed mill, with a specially equipped vehicle or on-farm – storing, transporting or placing on the market medicated feed and intermediate products, should be approved by the competent authority, in accordance with the approval system laid down in Regulation (EC) No 183/2005, in order to ensure both feed safety and product traceability. Feed business operators dealing with some lower risk activities, such as certain types of transport, storage and retail, should be exempted from the approval obligation, however this should not exempt them from the registration obligation under the registration system laid down in Regulation (EC) No 183/2005. To ensure appropriate use and full traceability for medicated feed, retailers of medicated feed for pets and keepers of fur animals feeding animals with medicated feed, which are not subject to the approval obligations, should provide information to competent authorities. Provision should be made for a transition procedure concerning establishments already approved under Directive 90/167/EEC.

Care should be taken to ensure that the medicated-feed-handling requirements laid down in this Regulation and in the delegated and implementing acts adopted pursuant to this Regulation concerning feed business operators, in particular on-farm mixers, are feasible and practical.

In order to ensure the safe use of medicated feed, its supply and use should be subject to presentation of a valid veterinary prescription for medicated feed which has been issued by a veterinarian after examination or any other proper assessment of the health status of the animals to be treated. However, the possibility to manufacture medicated feed before a veterinary prescription for medicated feed is presented to the manufacturer should not be excluded. Where medicated feed has been prescribed in a Member State by a veterinarian, it should as a general rule be possible for that veterinary prescription for medicated feed to be recognised and for the medicated feed to be dispensed in another Member State. By way of derogation, a Member State could allow a prescription for medicated feed to be issued by a professional person qualified to do so, other than a veterinarian, in accordance with applicable national law at the time of entry into force of this Regulation. Such a prescription for medicated feed issued by such a professional person, other than a veterinarian, should be valid only in that Member State and should exclude the prescription of medicated feed containing antimicrobial veterinary medicinal products and of any other veterinary medicinal products where a diagnosis by a veterinarian is necessary.

In order to ensure prudent use – which means appropriate use of medicines in accordance with the veterinary prescription for medicated feed and the summary of product characteristics – of medicated feed for food-producing animals and fur animals and therefore provide the basis for the assurance of a high level of protection of animal health and public health, specific conditions concerning the use and the validity of the veterinary prescription for medicated feed, compliance with the withdrawal period and record-keeping by the animal keeper, where appropriate, should be provided for.

Taking into account the serious public health risk posed by antimicrobial resistance, it is appropriate to limit the use of medicated feed containing antimicrobials for animals. Prophylaxis or use of medicated feed to enhance the performance of animals should not be allowed, except, in certain cases, as regards medicated feed containing antiparasitics and immunological veterinary medicinal products. The use of medicated feed containing antimicrobials for metaphylaxis should only be allowed when the risk of spread of an infection or of an infectious disease is high, in accordance with Regulation 2019/6.

The use of medicated feed containing some antiparasitics should be based on the knowledge of the parasite infestation status in the animal or group of animals. Despite the measures that farmers take to ensure good hygiene and biosecurity, animals may suffer from diseases which need to be prevented by medicated feed for reasons of both animal health and welfare. Animal diseases which are transmissible to humans may also have a significant impact on public health. Therefore the use of medicated feed containing immunological veterinary medicinal products or some antiparasitics should be allowed in the absence of a diagnosed disease.

In accordance with Regulation (EC) No 1831/2003, the ban on the use of antibiotics as growth promoting agents as from 1 January 2006 should be strictly adhered to and properly enforced.

The ‘One Health’ concept, endorsed by the WHO and the World Organization for Animal Health (OIE), recognises that human health, animal health and ecosystems are interconnected and it is therefore essential for both animal and human health to ensure prudent use of antimicrobial medicinal products in food-producing animals.

On 17 June 2016, the Council adopted conclusions on the next steps under a One Health approach to combat antimicrobial resistance. On 13 September 2018, the European Parliament adopted a resolution on a European One Health Action Plan against Antimicrobial Resistance.

A system for the collection or discard of unused or expired intermediate products and medicated feed should be in place, including through existing systems and when managed by feed business operators, in order to control any risk that such products might raise with regard to the protection of animal or human health or the environment. The decision as to who is responsible for such collection or discard system should remain a national competence. Member States should take measures to ensure that appropriate consultations with relevant stakeholders are carried out to ensure the fitness for purpose of such systems.

In order to comply with the objectives of this Regulation and to take into account technical progress and scientific developments, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the establishment of specific maximum levels of cross-contamination for active substances in non-target feed and methods of analysis for active substances in feed and of the amendment to the Annexes to this Regulation. Those Annexes concern provisions on feed business operators obligations related to the manufacture, storage, transport and placing on the market of medicated feed and intermediate products, the list of antimicrobial active substances which are most commonly used in medicated feed, the labelling requirements for medicated feed and intermediate products, the permitted tolerances for the compositional labelling of medicated feed or intermediate products and the mandatory information to be included in the veterinary prescription for medicated feed. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (11). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

In order to ensure uniform conditions for the implementation of this Regulation regarding the establishment of homogeneity criteria for medicated feed, as well as a model format for the veterinary prescription for medicated feed, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (12).

Member States should lay down rules on penalties applicable to infringement of this Regulation and should take all measures necessary to ensure that they are implemented. Such penalties should be effective, proportionate and dissuasive.

In order to ensure that all manufacturers of medicated feed, including on farm mixers, apply Annex II to Regulation (EC) No 183/2005, that Regulation should be amended accordingly.

Since the objectives of this Regulation, namely ensuring a high level of protection of human and animal health, providing adequate information for users and strengthening the effective functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

the manufacture, storage and transport of medicated feed and intermediate products;

the placing on the market, including import from third countries, and use of medicated feed and intermediate products;

the export to third countries of medicated feed and intermediate products. However, Articles 9, 16, 17 and 18 shall not apply to medicated feed and intermediate products whose label indicates that they are intended for export to third countries.

the definitions of ‘feed’, ‘feed business’ and ‘placing on the market’ as laid down, respectively, in points 4, 5 and 8 of Article 3 of Regulation (EC) No 178/2002;

the definitions of ‘feed additives’ and ‘daily ration’ as laid down, respectively, in points (a) and (f) of Article 2(2) of Regulation (EC) No 1831/2003;

the definitions of ‘food-producing animal’, ‘non-food-producing animals’, ‘fur animals’, ‘feed materials’, ‘compound feed’, ‘complete feed’, ‘complementary feed’, ‘mineral feed’, ‘minimum storage life’, ‘batch’, ‘labelling’ and ‘label’ as laid down, respectively, in points (c), (d), (e), (g), (h), (i), (j), (k), (q), (r), (s) and (t) of Article 3(2) of Regulation (EC) No 767/2009;

the definition of ‘establishment’ as laid down in point (d) of Article 3 of Regulation (EC) No 183/2005;

the definitions of ‘official controls’ and ‘competent authorities’ as laid down, respectively, in Article 2(1) and in point 3 of Article 3, of Regulation (EU) 2017/625;

the definitions of ‘veterinary medicinal product’, ‘active substance’, ‘immunological veterinary medicinal product’, ‘antimicrobial’, ‘antiparasitic’, ‘antibiotic’, ‘metaphylaxis’, ‘prophylaxis’, and ‘withdrawal period’, as laid down, respectively, in points 1, 3, 5, 12, 13, 14, 15, 16 and 34 of Article 4 of Regulation (EU) 2019/6, and ‘summary of the product characteristics’ referred to in Article 35 of that Regulation.

‘medicated feed’ means a feed, which is ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products or intermediate products with feed materials or compound feed;

‘intermediate product’ means a feed, which is not ready to be directly fed to animals without further processing, consisting of a homogenous mixture of one or more veterinary medicinal products with feed materials or compound feed, exclusively intended to be used for the manufacture of medicated feed;

‘non-target feed’ means feed, whether medicated or not, which is not intended to contain a specific active substance;

‘cross-contamination’ means contamination of a non-target feed with an active substance originating from the previous use of the facilities or equipment;

‘feed business operator’ means any natural or legal person responsible for ensuring that the requirements of this Regulation are met within the feed business under that person’s control;

‘mobile mixer’ means a feed business operator with a feed establishment consisting of a specifically equipped vehicle for the manufacture of medicated feed;

‘on-farm mixer’ means a feed business operator manufacturing medicated feed for the exclusive use on its farm;

‘veterinary prescription for medicated feed’ means a document issued by a veterinarian for a medicated feed;

‘advertising’ means the making of a representation in any form in connection with medicated feed and intermediate products in order to promote prescription or use of medicated feed comprising also the supply of samples and sponsorships;

‘animal keeper’ means any natural or legal person responsible for animals, whether on a permanent or on a temporary basis.

the medicated feed or intermediate product is manufactured in compliance with the relevant conditions laid down in the veterinary prescription for medicated feed or, in the cases referred to in Article 8 of this Regulation, in the summary of the product characteristics, related to the veterinary medicinal products to be incorporated in the feed; those conditions shall include particular provisions regarding known interactions between the veterinary medicinal products and the feed that may impair the safety or the efficacy of the medicated feed or intermediate product;

a feed additive authorised as a coccidiostat or a histomonostat for which a maximum content is set in the respective authorisation act is not incorporated in the medicated feed or intermediate product if it is already used as active substance in the veterinary medicinal product;

where the active substance in the veterinary medicinal product is the same as a substance in a feed additive contained in the feed concerned, the total content of that active substance in the medicated feed does not exceed the maximum content set out in the veterinary prescription for the medicated feed or, in the cases referred to in Article 8, in the summary of product characteristics;

the veterinary medicinal products incorporated in the feed combine with it to form a stable mixture for the entire storage life of the medicated feed, and respect the expiry date of the veterinary medicinal product, as referred to in point (f) of Article 10(1) of Regulation (EU) 2019/6, provided that the medicated feed or intermediate product is properly stored and handled.

on-farm mixers and mobile mixers;

manufacture of medicated feed or intermediate products incorporating veterinary medicinal products intended to be used in accordance with Article 112 or Article 113 of Regulation (EU) 2019/6.

those who only buy, store or transport medicated feed for the exclusive use on their farm;

those who act solely as traders, without holding the medicated feed or intermediate products in their premises;

those who only transport or store medicated feed or intermediate products exclusively in sealed packages or containers.

the presentation and, in case of manufacturing by on-farm mixers, the possession of a veterinary prescription for medicated feed; and

the conditions laid down in paragraphs 2 to 10.

comply with the summary of the product characteristics of the veterinary medicinal product, except for veterinary medicinal products intended to be used in accordance with Article 112, Article 113 or Article 114 of Regulation (EU) 2019/6;

indicate the daily dose of the veterinary medicinal product which is to be incorporated in a quantity of medicated feed that ensures the uptake of the dosage by the target animal considering that the feed uptake of diseased animals might differ from a normal daily ration;

ensure that the medicated feed containing the dosage of the veterinary medicinal product corresponds to at least 50 % of the daily feed ration on a dry matter basis and that, for ruminants, the daily dose of the veterinary medicinal product is contained in at least 50 % of the complementary feed except for mineral feed;

indicate the inclusion rate of the active substances, calculated on the basis of the relevant parameters.

in paragraph 1, point (c) is replaced by the following:

(*1)  Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1).’;"

paragraph 2 is replaced by the following:

‘2.   For operations other than those referred to in paragraph 1, including mixing of feed for the exclusive requirements of their own holdings when using veterinary medicinal products or intermediate products as defined in Regulation (EU) 2019/4 or additives or premixtures of additives, with the exception of silage additives, feed business operators shall comply with Annex II, where relevant for the operations carried out.’.

1.

Feed business operators shall ensure that facilities and equipment and their immediate surroundings are kept clean. Cleaning plans shall be introduced and be drawn up in writing, in order to ensure that any contamination, including cross-contamination is minimised.

2.

Feed business operators shall ensure that access to all facilities is restricted to authorised personnel.

1.

An adequately trained person responsible for the manufacture, placing on the market and supply to the animal keeper of medicated feed and intermediate products and an adequately trained person responsible for quality control shall be designated.

2.

With the exception of mobile mixers and on-farm mixers, the functions of the person responsible for manufacture and person responsible for quality control shall be independent of each other and therefore shall not be carried out by the same person.

1.

Feed business operators shall take account of requirements under relevant systems of quality assurance and good manufacturing practices, developed in accordance with Article 20 of Regulation (EC) No 183/2005.

2.

Medicated feed and intermediate products shall be stored separately from any other feed in order to avoid any cross-contamination.

3.

Veterinary medicinal products shall be stored in a separate secured room and in such a way that their characteristics are not altered.

4.

The material used for cleaning the production line after the manufacturing of medicated feed or intermediate products, shall be identified, stored and managed in such a way as not to affect the safety and quality of the feed.

1.

A quality control plan shall be drawn up in writing and implemented. It shall include, in particular, checks on the critical points in the manufacturing process, sampling procedures and frequencies, methods of analysis and their frequency, compliance with the specifications for the medicated feed and intermediate products and the measures to be taken in the event of non-compliance.

The quality control plan should define rules regarding sequencing or incompatibilities of manufacturing operations and, where applicable, define the need for dedicated production lines.

2.

Specific regular own checks as well as stability tests shall ensure compliance with the homogeneity criteria as laid down in accordance with Article 6(2), the maximum levels of cross-contamination for active substance in non-target feed as laid down in accordance with Article 7(2) and the minimum storage life of the medicated feed and the intermediate products.

1.

Medicated feed and intermediate products shall be stored in suitable separate and secured facilities or sealed in hermetic containers which are specially designed for the storage of such products. They shall be stored in places designed, adapted and maintained in order to ensure good storage conditions.

2.

Veterinary medicinal products shall be stored in separate, safe and secure areas. Those areas shall be of sufficient capacity and properly identified to allow orderly storage of the various veterinary medicinal products.

Medicated feed and intermediate products shall be stored and transported in such a way as to be easily identifiable. Medicated feed and intermediate products shall be transported in suitable means of transport.

3.

Specific facilities shall be identified for the storage of expired, withdrawn or returned medicated feed and intermediate products.

4.

Containers in vehicles used for the transport of medicated feed or intermediate products shall be cleaned after each use to avoid any risk of cross-contamination.

1.

Feed business operators manufacturing, storing, transporting or placing on the market medicated feed and intermediate products shall keep in a record relevant data, comprising details of purchase, manufacturing, storage, transport and placing on the market for effective tracing from receipt to delivery, including export to the final destination.

2.

The record referred to in paragraph 1 of this Section shall contain:

The documents listed in this paragraph shall be kept for at least five years in the record after their date of issuance.

1.

Feed business operators placing medicated feed and intermediate products on the market shall implement a system for registering and processing complaints.

2.

Feed business operators shall put in place a system for the prompt withdrawal from the market of medicated feed or intermediate products and, if necessary, for the recall of medicated feed or intermediate products from the distribution network in case they fail to comply with the requirements of this Regulation.

Feed business operators shall define by means of written procedures the destination of any recalled products, and before such products are put back into circulation the feed business operators shall carry out a quality-control reassessment to ensure that the Union feed safety requirements are complied with.

1.

Mobile mixers shall have a copy of the following documents available in the vehicle, in the official language of the Member State where the manufacture of medicated feed takes place:

2.

Mobile mixers shall take all the appropriate precautionary measures to prevent the spread of diseases. Vehicles used for the manufacture of medicated feed shall be cleaned after each use for the manufacture of medicated feed to avoid any risk of cross-contamination.

3.

Where vehicle registration plate numbers are available, mobile mixers shall use only those vehicles whose vehicle registration plate numbers have been notified to the competent authority.

the expression ‘Medicated feed’ or ‘Intermediate product for the manufacturing of medicated feed’ as appropriate;

the approval number of the feed business operator responsible for the labelling. In cases where the manufacturer is not the feed business operator responsible for the labelling, the following shall be provided:

the active substances with name, added amount (mg/kg), and the veterinary medicinal products with its marketing authorisation number and the marketing authorisation holder, preceded by the heading ‘medication’;

any contra-indications of the veterinary medicinal products and adverse events in so far as those particulars are necessary for the use;

in the case of a medicated feed or of intermediate product intended for food-producing animals, the withdrawal period or the indication ‘no withdrawal period’;

in the case of medicated feed for non-food-producing animals, except fur animals, a warning that the medicated feed is only for the treatment of animals and a warning that it must be kept out of the sight and reach of children;

a free telephone number or other appropriate means of communication in order to allow the animal keeper to obtain, in addition to the mandatory particulars, the package leaflet of each veterinary medicinal product;

the instructions for use in line with the veterinary prescription for medicated feed or the summary of the product characteristics;

the minimum storage life, which shall take into account the expiry dates of the veterinary medicinal products and shall be expressed as ‘use before…’, followed by the date, and special storage precautions, if appropriate;

information that inappropriate disposal of medicated feed poses serious threats to the environment and may, where relevant, contribute to antimicrobial resistance.

1.

Full name and contact details of the veterinarian including, if available, the professional number.

2.

Issue date, unique number of prescription, expiry date of prescription (if the validity is shorter than that referred to in Article 16(8)) and signature or an equivalent electronic form of identification of the veterinarian.

3.

Full name and contact details of the animal keeper, and identification number of the establishment, if existing.

4.

Identification (including category, species and age) and number of animals or, where appropriate, the weight of the animals.

5.

Diagnosed disease to be treated. In the case of immunological veterinary medicinal products or antiparasitics without antimicrobial effects, disease to be prevented.

6.

Designation (name and marketing authorisation number) of the veterinary medicinal product or products, including the name of the active substance or substances.

7.

If the veterinary medicinal product is prescribed under Article 107(4), Article 112, Article 113 or Article 114, of Regulation (EU) 2019/6, a statement to that effect.

8.

Inclusion rate of the veterinary medicinal product or products and active substance or substances (quantity per weight unit of medicated feed).

9.

Quantity of medicated feed.

10.

Instructions for use for the animal keeper, including the duration of the treatment.

11.

Percentage of medicated feed in the daily ration or quantity of medicated feed per animal and day.

12.

For food-producing animals, withdrawal period, even if such period is zero.

13.

Any warnings necessary to ensure the proper use including, where relevant, to ensure prudent use of antimicrobials.

14.

For food-producing animals and fur animals, the mention ‘This prescription shall not be re-used’.

15.

The following mentions to be completed by the supplier of the medicated feed or the on-farm mixer, as appropriate:

16.

Signature of supplier to the animal keeper or of on-farm mixer.