Regulation 14
SCHEDULE 5Medicated feedingstuffs and specified feed additives
1.Scope and interpretation
2.Enforcement of Regulation (EC) No 178/2002
3.Enforcement of Regulation (EC) No 1831/2003
4.Enforcement of Regulation (EC) No 882/2004
5.Enforcement of Regulation (EC) No 183/2005
6.Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
7.Incorporation of a veterinary medicinal product into a premixture
8.Top dressing
9.Incorporation of a veterinary medicinal product into feedingstuffs
10.Additional record keeping requirements relating to veterinary medicinal products
11.Labelling a premixture containing a veterinary medicinal product
12.Labelling of feedingstuffs containing a specified feed additive
13.Labelling of feedingstuffs containing a veterinary medicinal product
14.Supply of specified feed additives
15.Supply of premixture
16.Supply of feedingstuffs containing a veterinary medicinal product
17.Prescriptions for feedingstuffs containing a veterinary medicinal product
18.Writing the prescription
19.Possession
20.Sampling and analysis
21.Storage
22.Packages and other containers
23.Transport
24.Possession, placing on the market and use of feedingstuffs
25.Imports from third countries
26.Trade between member States
27.Import for incorporation into premixture or feedingstuffs for export
28.Animals on domestic premises
Scope and interpretation
1.—(1) This Schedule applies in relation to the following (referred to in this Schedule as “specified feed additives”) when used as feed additives—
(a)coccidiostats;
(b)histomonostats; and
(c)all other zootechnical additives except—
(i)digestibility enhancers;
(ii)gut flora stabilisers; and
(iii)substances incorporated with the intention of favourably affecting the environment.
(2) It also applies in relation to the manufacture and placing on the market of feedingstuffs containing a veterinary medicinal product.
(3) In this Schedule—
“premixture” means a mixture of a veterinary medicinal product or a specified feed additive with feedingstuffs materials, intended for further mixing with feedingstuffs before being fed to animals;
“zootechnical additive” means any additive used to maintain animals in good health or favourably affect their performance.
Enforcement of Regulation (EC) No 178/2002
2.—(1) For the purposes of Regulation (EC) No 178/2002 (of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(1)) the competent authority is the Secretary of State.
(2) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—
(a)Article 11 (requirements relating to imports);
(b)Article 12 (requirements relating to exports);
(c)Article 15 (1) (prohibition on the placing on the market or feeding unsafe feedingstuffs);
(d)Article 16 so far as it prohibits misleading labelling, advertising or presentation of feedingstuffs;
(e)Article 18 (2) and (3) (requirements of traceability) in so far as it relates to feed business operators; and
(f)Article 20 (responsibilities of feed business operators).
Enforcement of Regulation (EC) No 1831/2003
3.—(1) For the purposes of Regulation (EC) No 1831/2003 (of the European Parliament and the Council on additives for use in animal nutrition(2)) the competent authority is the Secretary of State.
(2) An authorisation under Article 3(2) of that Regulation must be in writing.
(3) It is an offence to be in possession of a specified feed additive, or a premixture or feedingstuffs containing a specified feed additive, unless the specified feed additive has been authorised under Regulation (EC) No 1831/2003 or is for export to a third country.
(4) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—
(a)Article 3(1) or Article 3(3) (the authorisation, conditions of use and labelling of specified feed additives);
(b)Article 12(1) or (2) (conditions relating to specified feed additives);
(c)Article 16(1) (labelling);
(d)Article 16(3) (additional labelling requirement);
(e)Article 16(4) (premixtures containing specified feed additives);
(f)Article 16(5) (packaging).
Enforcement of Regulation (EC) No 882/2004
4. For the purposes of Regulation (EC) No. 882/2004 (of the European Parliament and the Council on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules(3)) the competent authority is the Secretary of State.
Enforcement of Regulation (EC) No 183/2005
5.—(1) For the purposes of Regulation (EC) No 183/2005 (of the European Parliament and of the Council laying down requirements for feed hygiene(4)) the competent authority is the Secretary of State.
(2) Any person who contravenes any of the following provisions of that Regulation is guilty of an offence—
(a)Article 5(2), (5) or (6) (specific obligations);
(b)Article 6(1) as read with (2) and (3) (HACCP system);
(c)Article 7(1) (documents concerning the HACCP system);
(d)Article 9(2) (official controls, notification and registration);
(e)Article 11 (prohibition on operating without approval or registration);
(f)Article 17(2) (exemption from on-site visits);
(g)Article 18(3) (declaration of compliance);
(h)Article 23(1) (conditions relating to imports from third countries);
(i)Article 25 (feedingstuffs produced for export to third countries).
(3) A manufacturer must ensure that, so far as is reasonably practicable, the active ingredient is evenly incorporated throughout the feedingstuffs and failure to do so is an offence.
(4) In the case of the refusal, suspension or revocation of an approval under the Regulation the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.
Approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal products
6.—(1) It is an offence to incorporate a veterinary medicinal product into a premixture or feedingstuffs, or to act as a distributor of premixtures or feedingstuffs containing a veterinary medicinal product, without being approved to do so by the Secretary of State.
(2) The provisions of this paragraph do not apply in relation to any person breeding or selling ornamental fish not intended for human consumption provided that that person does not use more than a total of 1kg of veterinary medicinal product annually for that purpose.
(3) The provisions of Regulation (EC) No 183/2005 apply to those manufacturers and distributors in the same way as to persons approved under Article 9 of that Regulation.
(4) A manufacturer must ensure that, so far as is reasonably practicable, the veterinary medicinal product is evenly incorporated throughout the feedingstuffs and failure to do so is an offence.
(5) In the case of the refusal, suspension or revocation of an approval under this paragraph the appeals procedure relating to a manufacturing authorisation in regulation 30 applies.
Incorporation of a veterinary medicinal product into a premixture
7.—(1) Any person who incorporates a veterinary medicinal product into a premixture—
(a)must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there; and
(b)must ensure that the veterinary medicinal product does not contain the same active substance as any other additive.
(2) It is an offence to fail to comply with this paragraph.
Top dressing
8. It is an offence to promote or label any veterinary medicinal product, or anything containing a veterinary medicinal product, as being suitable for top dressing (that is, sprinkling it on to feedingstuffs without thoroughly incorporating it) unless the summary of product characteristics specifically permits this use.
Incorporation of a veterinary medicinal product into feedingstuffs
9.—(1) Any person who incorporates a veterinary medicinal product (or a premixture containing a veterinary medicinal product) into feedingstuffs—
(a)must do so in accordance with the summary of product characteristics, and must take account of any interactions listed there;
(b)must ensure that the veterinary medicinal product does not contain the same active substance as any other additive;
(c)must ensure that the veterinary medicinal product is incorporated in accordance with its marketing authorisation (unless it has been prescribed under the cascade) and the prescription;
(d)must ensure that the daily dose of the veterinary medicinal product is contained in a quantity of medicated feedingstuffs corresponding to at least half the daily feedingstuffs ration of the animals treated or, in the case of ruminants, corresponding to at least half the daily requirements of non-mineral complementary feedingstuffs.
(2) It is an offence to fail to comply with this paragraph.
Additional record keeping requirements relating to veterinary medicinal products
10.—(1) Any person who—
(a)incorporates a veterinary medicinal product into a premixture;
(b)incorporates a premixture containing a veterinary medicinal product into feedingstuffs; or
(c)incorporates a veterinary medicinal product into feedingstuffs,
must make a daily record of—
(d)the types and quantities of all veterinary medicinal products (and specified feed additives, if any) and premixture used in the manufacturing process; and
(e)the quantity of feedingstuffs and premixture containing veterinary medicinal product manufactured that day.
(2) An approved distributor must make a daily record of—
(a)the types and quantities of all premixtures and feedingstuffs containing veterinary medicinal products bought and sold that day;
(b)the quantity held.
(3) A manufacturer and distributor must also record, as soon as reasonably practicable, for each consignment supplied—
(a)the date of delivery;
(b)the name and address of each consignee (or, in the case of a manufacturer supplying to a distributor, the name and address of the distributor);
(c)the type of feedingstuffs or premixture supplied;
(d)the quantity;
(e)the type of veterinary medicinal product incorporated into the feedingstuffs; and
(f)the expiry date.
(4) Records must be kept for five years.
(5) It is an offence to fail to comply with this paragraph.
Labelling a premixture containing a veterinary medicinal product
11.—(1) A premixture containing a veterinary medicinal product must be clearly and legibly labelled with the following—
(a)the words “MEDICATED PREMIXTURE” (or, if it is to be labelled as “complementary feedingstuffs” under legislation implementing Council Directive 79/373/EEC on the marketing of compound feedingstuffs(5), “MEDICATED COMPLEMENTARY FEEDINGSTUFFS” ) in upper case letters;
(b)the proprietary name of the veterinary medicinal product and the authorisation number;
(c)the name and amount of the active substance (mg/kg) in the premixture;
(d)the range of acceptable inclusion rates of the premixture into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the prescription for the exact inclusion rate” or equivalent wording;
(e)warnings and contra-indications;
(f)the withdrawal period, and a statement that, if the prescription requires a longer withdrawal period, that is the one that applies;
(g)the expiry date;
(h)any special storage instructions;
(i)where a prescription is required, a statement to this effect.
(2) If there is more than one veterinary medicinal product used, the longest withdrawal period must be shown on the label.
(3) If the premixture also contains a specified feed additive to which this Schedule applies it must also contain the information required under Article 16 of Regulation (EC) No 1831/2003.
(4) It is an offence to supply such a premixture not labelled in accordance with this paragraph.
Labelling of feedingstuffs containing a specified feed additive
12.—(1) Feedingstuffs containing a specified feed additive must be clearly and legibly labelled with the following—
(a)the name of the specified feed additive;
(b)the name and amount of the active substance (mg/kg) in the feedingstuffs;
(c)the withdrawal period if one is specified in the authorisation;
(d)the expiry date;
(e)the name and approval number of the manufacturer or the distributor;
(f)any particulars concerning the proper use of the feedingstuffs specified in the authorisation of the specified feed additive.
(2) It is an offence to supply such feedingstuffs not labelled in accordance with this paragraph.
Labelling of feedingstuffs containing a veterinary medicinal product
13.—(1) Feedingstuffs containing a veterinary medicinal product must be clearly and legibly labelled with the following—
(a)the words “MEDICATED COMPLETE FEED” in upper case letters;
(b)the proprietary name, authorisation number and inclusion rate (kg/tonne or mg/kg) of the veterinary medicinal product incorporated into the feedingstuffs;
(c)the name and amount of the active substance (mg/kg) in the feedingstuffs;
(d)the species of animal for which the feedingstuffs are intended;
(e)warnings and contra-indications;
(f)the withdrawal period, and a statement that, if the prescription requires a longer withdrawal period, that is the one that applies;
(g)the expiry date;
(h)any special storage instructions required by the marketing authorisation;
(i)a statement to the effect that the feedingstuffs must only be fed in accordance with its prescription;
(j)the name and approval number of the manufacturer or the distributor.
(2) If there is more than one veterinary medicinal product used, the longest withdrawal period must be shown on the label.
(3) It is an offence to supply feedingstuffs not labelled in accordance with this paragraph.
Supply of specified feed additives
14.—(1) It is an offence for any person other than the person who manufactured a specified feed additive or an approved distributor to supply a specified feed additive.
(2) The person who manufactured the specified feed additive may only supply it to—
(a)an approved distributor;
(b)an approved premixture manufacturer; or
(c)a feedingstuff manufacturer approved to mix a specified feed additive directly into feedingstuff.
(3) An approved distributor may only supply it to—
(a)another approved distributor;
(b)an approved premixture manufacturer; or
(c)a feedingstuff manufacturer approved to mix a specified feed additive directly into feedingstuff.
(4) It is an offence for a manufacturer or distributor to supply a specified feed additive to anyone not specified in this paragraph.
Supply of premixture
15.—(1) It is an offence for any person other than the person who manufactured a premixture or an approved distributor to supply a premixture.
(2) The person who manufactured the premixture may only supply it to—
(a)an approved distributor; or
(b)a feedingstuff manufacturer approved to incorporate that premixture.
(3) An approved distributor may only supply it to—
(a)another approved distributor, or
(b)a feedingstuff manufacturer approved to incorporate that premixture.
(4) It is an offence for a manufacturer or distributor to supply a premixture to anyone not specified in this paragraph.
Supply of feedingstuffs containing a veterinary medicinal product
16.—(1) It is an offence for any person other than the person who manufactured the feedingstuffs or an approved distributor to supply feedingstuffs containing a veterinary medicinal product.
(2) The person who manufactured the feedingstuff may only supply it to—
(a)an approved distributor, or
(b)a person who keeps animals for feeding to those animals.
(3) A distributor may only supply it to—
(a)another approved distributor, or
(b)a person who keeps animals for feeding to those animals.
(4) Supply to a person who keeps animals must be in accordance with a written prescription as specified in the following paragraph.
(5) If a prescription is for a period of longer than one month, the supplier may not provide more than one month’s supply at any one time.
(6) It is an offence for a manufacturer or distributor to supply a feedingstuff to anyone not specified in this paragraph, or otherwise than in accordance with this paragraph.
(7) The person supplying the feedingstuff must keep the prescription for five years, and failure to do so is an offence.
Prescriptions for feedingstuffs containing a veterinary medicinal product
17.—(1) A prescription for feedingstuffs containing a veterinary medicinal product must contain the following—
(a)the name and address of the person prescribing the product;
(b)the qualifications enabling the person to prescribe the product;
(c)the name and address of the keeper of the animals to be treated;
(d)the species of animal, identification and number of the animals;
(e)the premises at which the animals are kept if this is different from the address of the keeper;
(f)the date of the prescription;
(g)the signature or other authentication of the person prescribing the product;
(h)the name and amount of the product prescribed;
(i)the dosage and administration instructions;
(j)any necessary warnings;
(k)the withdrawal period;
(l)the manufacturer or the distributor of the feedingstuffs (who must be approved for the purpose);
(m)if the validity exceeds one month, a statement that not more than 31 days supply may be provided at any time;
(n)the name, type and quantity of feedingstuffs to be used;
(o)the inclusion rate of the veterinary medicinal product and the resulting inclusion rate of the active substance;
(p)any special instructions;
(q)the percentage of the prescribed feedingstuffs to be added to the daily ration; and
(r)if it is prescribed under the cascade, a statement to that effect.
(2) It is valid for three months or such shorter period as may be specified in the prescription.
(3) It must be sufficient for only one course of treatment.
Writing the prescription
18.—(1) The person who writes the prescription must—
(a)give a copy to the person incorporating the veterinary medicinal product into the feedingstuffs or to the distributor of the feedingstuffs;
(b)give one copy to the keeper of the animals to be treated;
(c)keep a copy.
(2) The person must be satisfied that—
(a)there is no undesirable interaction between the veterinary medicinal product and any feed additive used in the feedingstuffs; and
(b)the active substance of the veterinary medicinal product is not the same as an active substance in any feed additive used in the feedingstuffs.
(3) If there is no suitable veterinary medicinal product a veterinary surgeon may—
(a)prescribe a veterinary medicinal product authorised for another species and condition, or
(b)include more than one veterinary medicinal product for incorporation into the feedingstuff,
provided that all veterinary medicinal products prescribed are authorised for inclusion in feedingstuffs.
(4) It is an offence to fail to comply with this paragraph.
Possession
19.—(1) It is an offence for any person other than a person holding the appropriate approval under this Schedule to be in possession of any—
(a)specified feed additive or veterinary medicinal product to which this Schedule applies;
(b)premixtures containing such an additive or a veterinary medicinal product; or
(c)feedingstuffs containing such an additive or a veterinary medicinal product unless supplied under these Regulations.
(2) It is an offence for any person other than a manufacturer or distributor to be in possession of feedingstuffs incorporating a veterinary medicinal product unless it has been supplied under a prescription.
Sampling and analysis
20.—(1) If any enforcement action is taken under this Schedule based on a sample, that sample must have been taken and analysed in accordance with Council Directive 76/371/EEC (establishing Community methods of sampling for the official control of feedingstuffs(6)).
(2) Unless otherwise specified in the marketing authorisation, it is a defence if the active ingredient in the sample is within the following tolerances—
Tolerance table
Storage
21. It is an offence to store a veterinary medicinal product intended for incorporation into feedingstuffs, or a premixture or feedingstuffs containing a veterinary medicinal product, except in—
(a)a suitable storage area that is locked when not in use, or
(b)a hermetic container designed to store those products.
Packages and other containers
22. It is an offence to place on the market feedingstuffs containing a veterinary medicinal product except in packages or containers that are sealed in such a way that, when the package or container is opened, the seal is damaged.
Transport
23.—(1) In the case of feedingstuffs distributed by road tankers or in bulk the labelling requirements must be given in a document accompanying the feedingstuffs, and the transporter must hand over details when delivering the feedingstuffs unless these have already been provided to the purchaser.
(2) Any person transporting feedingstuffs containing veterinary medicinal products or specified feed additives in road tankers or similar containers must ensure that the vehicle or container is cleaned before any re-use if this is necessary to prevent undesirable interaction or contamination.
(3) In the case of feedingstuffs containing a veterinary medicinal product the transporter must ensure that the vehicle is accompanied by documentation stating this.
(4) Any person operating an undertaking transporting feedingstuffs containing veterinary medicinal products or specified feed additives must give written instructions to drivers on how to load and unload vehicles so as to avoid cross-contamination, and take reasonable steps to ensure that the driver complies with those instructions.
(5) It is an offence to fail to comply with this paragraph.
Possession, placing on the market and use of feedingstuffs
24.—(1) It is an offence for any person to possess, place on the market or feed to animals any feedingstuffs incorporating veterinary medicinal products or specified feed additives unless they have been incorporated in accordance with this Schedule.
(2) It is an offence to feed to any animal, or buy, possess or supply for the purpose of feeding to any animal, any feedingstuff containing a veterinary medicinal product or specified feed additive unless—
(a)that veterinary medicinal product or specified feed additive is authorised for that species of animal and for the purpose for which it is used, or
(b)in the case of a veterinary medicinal product, it was prescribed for that animal.
(3) This paragraph does not apply in relation to feedingstuffs if the veterinary medicinal product has been incorporated in accordance with an animal test certificate or the feedingstuff has been imported in accordance with this Schedule.
Imports from third countries
25. Any person who imports a feedingstuff containing a veterinary medicinal product from a third country is guilty of an offence.
Trade between member States
26. Any person who brings in from another member State a feedingstuff containing a veterinary medicinal product is guilty of an offence unless—
(a)the feedingstuff has been manufactured in accordance with the provisions of Council Directive 90/167/EEC (laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community(7)) and Regulation (EC) No 183/2005; and
(b)it only contains a veterinary medicinal product that has the same quantitative and qualitative composition as a veterinary medicinal product authorised in the United Kingdom.
Import for incorporation into premixture or feedingstuffs for export
27.—(1) A manufacturer of premixture or feedingstuffs who imports a veterinary medicinal product authorised in another member State or third country for the purpose of incorporating it into premixture or feedingstuffs for export does not commit an offence under regulation 25 (importation of an unauthorised veterinary medicinal product) or regulation 26 (possession of an unauthorised veterinary medicinal product).
(2) It is an offence to place that premixture or feedingstuff on the market in the United Kingdom once the veterinary medicinal product has been incorporated into it.
Animals on domestic premises
28.—(1) The requirements of paragraph 6 (approval of manufacturers and distributors of feedingstuffs containing veterinary medicinal product) do not apply in relation to a person who incorporates a veterinary medicinal product into feedingstuffs in domestic premises for feeding, on those premises—
(a)non-food-producing animals, or
(b)food-producing animals kept purely for domestic consumption.
(2) Notwithstanding paragraphs 15 and 16 of this Schedule, a suitably qualified person registered in accordance with paragraph 14 of Schedule 3 may be supplied with and may supply a premixture containing a veterinary medicinal product, or feedingstuffs containing a veterinary medicinal product, to such a producer provided that—
(a)in the case of premixture, the amount of premixture is intended to be mixed into a final feed not exceeding 30 kg, and
(b)in the case of feedingstuffs, the total weight of feed supplied at any one time does not exceed 30 kg.
(3) The requirement for a written prescription does not apply in relation to such supply, but the provisions of Schedule 3 relating to supply of a veterinary medicinal product apply in relation to the supply of premixture and feedingstuffs in the same way as they apply to a veterinary medicinal product.
OJ No L 31, 1.2.2002, p. 1.
OJ No L268, 18.10.2003, p. 29.
Corrected version at OJ No L191, 28.5.2004, p. 1.
OJ No L35, 8.2.2005, p. 1.
OJ No L86, 6.4.1979, p. 30.
OJ No L102, 15.4.76, p. 1.
OJ No L 92, 7.4.90, p. 42.