16.2.82 Official Journal of the European Communities No C 41/3 
II 
(Preparatory Acts) 
COMMISSION 
Proposal for a Council Directive on the manufacture, putting into circulation and supply 
of medicated feedingstuffs in the Community 
(Submitted by the Commission to the Council on 20 January 1982) 
THE COUNCIL OF THE EUROPEAN 
COMMUNITIES, 
Having regard to the Treaty establishing the 
European Economic Community, and in particular 
Article 43 thereof, 
Having regard to the proposal from the Commission, 
Having regard to the opinion of the European 
Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas, to safeguard public health from any dangers 
arising from the use of medicated feedingstuffs for 
animals intended for food production, and to prevent 
distortions in competition in the keeping and rearing 
of farm animals, conditions should be laid down 
regarding the manufacture, putting into circulation 
and supply of medicated feedingstuffs; 
Whereas Community rules regarding medicinal 
products, in the form of Council Directive 
65/65/EEC of 26 January 1965 on the approximation 
of provisions laid down by law, regulation or 
administrative action relating to proprietary medicinal 
products ('), the second Council Directive 
75/319/EEC of 20 May 1975 on the approximation 
of provisions laid down by law, regulation or administrative action relating to proprietary medicinal 
products (2), Council Directive 81/851/EEC of 
28 September 1981 on the approximation of the laws 
of Member States relating to veterinary medicinal 
products (J) and Council Directive 81/852/EEC of 
28 September 1981 on the approximation of the laws 
of Member States relating to analytical, pharmaco-
toxicological and clinical standards and protocols 
in respect of the testing of veterinary medicinal pro­
ducts (*), should be taken into account; 
Whereas account must also be taken of Community 
rules on feedingstuffs in the form of Council 
Directive 70/524/EEC of 23 November 1970 
concerning additives in feedingstuffs (5), as last 
amended by the 38th Commission Directive 
81/632/EEC C), and of Council Directive 
79/373/EEC of 2 April 1979 on the marketing of 
compound feedingstuffs (7); 
Whereas medicated feedingstuffs must in principle be 
manufactured under the same conditions as those 
applying to veterinary medicinal products; whereas, 
however, since in the manufacture of medicated 
feedingstuffs simple mixing is usually the main 
process, only authorized pre-mixes may be used and 
precise instructions are given in a prescription or 
standard prescription, the person responsible for 
manufacture required by the rules on medicinal 
(') OJ No 22, 9. 2. 1965, p. 369. O OJ No L 147, 9. 6. 1975, p. 13. 
O OJNoL317, 6. 11. 1981, p. 1. 
(4) OJNoL317, 6. 11. 1981, p. 16. 
(s) OJ No L 270, 14. 12. 1970, p. 1. 
(') OJ No L 231, 15. 8. 1981, p. 30. 
(7) OJ No L 86, 6. 4. 1979, p. 30. 
No C 41/4 Official Journal of the European Communities 16.2.82 
products may be replaced by a person with adequate 
knowledge of mixing techniques; 
Whereas the supply of medicated feedingstuffs to 
stockfarmers may only be by prescription of a veteri­
narian, who must himself comply with particular 
conditions when issuing the prescription; 
Whereas, in order for there to be effective control, 
the persons concerned must be required to keep a 
register or to retain the relevant documents for a 
specified period of time; 
Whereas, for the authorization of medicated 
feedingstuffs from standard prescriptions in intra-
Community trade, a procedure should be chosen 
which ensures close cooperation between the 
Commission and the Member States, 
HAS ADOPTED THIS DIRECTIVE: 
CHAPTER I 
Definitions and scope 
Article .1 
This Directive covers the manufacture and putting in 
circulation of medicated feedingstuffs and their 
supply to livestock farmers within the Community, as 
well as intra-Community trade in these products. 
Article 2 
For the purposes of this Directive the following 
definitions shall apply: 
(a) medicated feedingstuff: any mixture of one or 
more veterinary medicinal products and one or 
more feedingstuffs which is prepared prior to 
being put into circulation and which, because of 
its prophylactic or therapeutic properties or other 
properties as referred to in Article 1 (2) of 
Directive 65/65/EEC is intended to be fed to 
animals without alteration; 
(b) pre-mix for medicated feedingstuffs: any veterinary 
medicinal product prepared in advance with a 
view to the subsequent manufacture of medicated 
feedingstuffs; 
(c) authorized pre-mix: any pre-mix for medicated 
feedingstuffs for which an authorization has been 
granted in accordance with Article 4 of Directive 81/851/EEC on the approximation of the laws of 
Member States relating to veterinary medicinal 
products; 
(d) intermediate product: any mixture of one or more 
pre-mixes for medicated feedingstuffs and one or 
more feedingstuffs which is prepared in advance 
with a view to the subsequent manufacture of 
medicated feedingstuffs; 
(e) veterinary medicinal product: any medicinal 
product intended for animals; 
(f) putting into circulation: the holding for sale or 
any other disposal, and any kind of disposal to 
others, whether or not for consideration; 
(g) additives: substances which, when incorporated in 
feedingstuffs, are likely to affect their charac­
teristics on livestock production; 
(h) feedingstuffs: organic or inorganic substances, 
used singly or in mixtures, whether or not 
containing additives, for oral animal feeding; 
(i) daily ration: the average total quantity of 
feedingstuffs, calculated on a moisture content of 
12 %, required daily by an animal of a given 
species, age category and performance to satisfy 
all its nutritional requirements; 
(j) complete feedingstuffs: mixtures of feedingstuffs 
which, by reason of their composition, are 
sufficient for a daily ration; 
(k) supplementary feedingstuffs: mixtures of 
feedingstuffs which have a high content of certain 
substances and which, by reason of their 
composition, are sufficient for a daily ration only 
if they are used in combination with other 
feedingstuffs; 
(1) mineral feedingstuffs: supplementary feedingstuffs 
which are composed mainly of minerals and 
contain at least 40 % crude ash; 
(m) standard prescription: officially recognized pre­
scription for the manufacture of a medicated 
feedingstuff. 
Article 3 
1. This Directive shall be without prejudice to 
other Community provisions on feedingstuffs. 
2. The provisions of this Directive shall not apply 
to medicated feedingstuffs shown, at least by appro­
priate markings, to be intended for export to non-
member countries. 
16.2.82 Official Journal of the European Communities No C 41/5 
CHAPTER II 
Manufacture of medicated feedingstuffs 
Article 4 
1. As regards the content of medicinal products, 
medicated feedingstuffs may be manufactured only 
from pre-mixes authorized for that purpose. 
2. Medicated feedingstuffs may be manufactured 
only from a veterinary prescription or from a 
standard prescription authorized in accordance with 
Article 14 (2). 
3. By way of derogation from paragraph 2, 
however, Member States may authorize other 
standard prescriptions for the manufacture of 
medicated feedingstuffs. Such standard prescriptions 
shall require the approval of the competent central 
authority of the Member State. 
Article 5 
Member States shall take all appropriate measures to 
ensure that medicated feedingstuffs are manufactured 
only under the conditions set out below: 
1. The manufacturer must have suitable and adequate 
premises, technical equipment, storage and 
inspection facilities. 
2. The manufacturer must have available the services 
of proficient staff to comply with the conditions 
regarding manufacture. In particular, staff with an 
adequate knowledge of mixing techniques must be 
present in the manufacturing plant. 
3. Only complete or supplementary feedingstuffs, not 
including mineral feeds, which comply with the 
Community provisions on feedingstuffs may be 
used. The feedingstuffs used must demonstrably 
allow of homogeneous and stable mixing with the 
veterinary medicinal product and it must be 
possible to store it for an appropriate period. In 
particular, the feedingstuff used may not contain 
any additives which affect the action of the 
veterinary medicinal product. 
4. In respect of premises, staff and equipment the 
entire manufacturing process must comply with 
provisions of the Member State ensuring the 
observance of recognized principles of hygiene, 
with a view, in particular, to avoiding contami­
nation between veterinary medicinal products or 
feedingstuffs. 5. The medicated feedingstuffs manufactured must be 
checked regularly in accordance with national 
provisions, especially in respect of homogeneity 
and stability of the mixture and storability. 
6. Manufacturers must keep records, on the basis of 
immediate entries, of the types and quantities of 
pre-mixes and feedingstuffs used and of medicated 
feedingstuffs manufactured, put into storage or 
dispatched, the names and addresses of recipients 
and, where delivery is direct to stockfarmers, the 
name and address of the prescribing veterinarian. 
The record must be retained for at least one year 
after the date of the last entry and be made 
available at any time to the inspection authorities. 
7. Pre-mixes, intermediate products and medicated 
feedingstuffs must be stored in suitable separate 
rooms or containers which are specially designed 
for the purpose and which can be locked. 
Article 6 
By way of derogation from Article 4 (1), medicated 
feedingstuffs may be manufactured without the use of 
an authorized pre-mix if appropriate measures are 
taken to ensure that in addition to the provisions of 
this Directive, in particular Article 5, the provisions of 
Directive 81/851/EEC and Directive 81/852/EEC 
are complied with, and that in particular the manu­
facturer disposes of the services of a qualified person 
as defined in Article 31 of Directive 81/851/EEC. 
In such cases the medicated feedingstuff shall require 
authorization under Article 4 of the abovementioned 
Directive 81/851/EEC. 
Article 7 
Member States may provide that medicated 
feedingstuffs may be manufactured from intermediate 
products and that these intermediate products may be 
put into circulation. 
Such intermediate products may be manufactured 
only from authorized pre-mixes with the addition of 
feedingstuffs. 
Member States shall ensure that intermediate 
products are subject to the supervision of the 
competent authorities, that they may be used only for 
the manufacture of medicated feedingstuffs and that 
their use is subject to the conditions governing the 
putting into circulation of the pre-mix used. 
No C 41/6 Official Journal of the European Communities 16.2.82 
CHAPTER III 
Packaging and labelling 
Article 8 
Member States shall prescribe that medicated 
feedingstuffs may be supplied only in containers 
which ensure that their condition is not impaired. 
Whenever medicated feedingstuffs are put into circu­
lation in road tankers or similar containers, these 
must be thoroughly cleaned before any re-use in 
order to prevent contamination. 
Article 9 
1. Member States shall take all appropriate 
measures to ensure that medicated feedingstuffs are 
not put into circulation unless the labelling fulfils the 
requirements: 
— Chapter VII of Directive 81/851/EEC, in respect 
of the medicinal products used, and 
— Council Directive 70/524/EEC and Council 
Directive 79/373/EEC, in respect of the 
feedingstuffs used. 
Medicated feedingstuffs must further bear the clearly 
visible words 'Medicated feedingstuff and an 
indication as to what proportion of the daily ration 
they are intended to represent. 
2. Whenever medicated feedingstuffs are put into 
circulation in road tankers or similar containers, it 
shall be sufficient for the indications referred to in 
paragraph 1 to be contained in the accompanying 
documents. 
CHAPTER IV 
Putting into circulation and supply of medicated 
feedingstuffs 
Article 10 
1. Member States shall take all appropriate 
measures to ensure that a medicated feedingstuff is 
put into circulation only if it has been manufactured 
in accordance with the provisions of this Directive 
and, in cases as referred to in Article 6, the authori­
zation provided for has been granted. 2. Except in cases of tests of medicinal products 
carried out pursuant to Article 5 (10) of Directive 
81/851/EEC a medicated feedingstuff may not be 
administered to animals unless the conditions laid 
down in paragraph 1 are fulfilled. 
3. Articles 5, 6 and 7 of Directive 81/851/EEC 
shall apply to applications for authorization to put 
into circulation a medicated feedingstuff manu­
factured in accordance with Article 6 of this 
Directive. 
As regards indication of the components of the 
medicated feedingstuff, however, it shall be sufficient 
to indicate the main components of the feedingstuff 
used. 
As regards examination of applications for authori­
zation, Chapter III of Directive 81/851/EEC and 
Directive 81/852/EEC shall apply. 
Article 11 
Member States shall ensure that medicated 
feedingstuffs are put into circulation only if the daily 
dose of medicinal product is contained in a quantity 
of feedingstuff corresponding to at least half the daily 
feed ration of the animals treated or, in the case of 
ruminants, half the daily requirements of non-mineral 
supplementary feedingstuffs. 
Article 12 
1. Member States shall prescribe that medicated 
feedingstuffs may be supplied to stockfarmers only on 
presentation of a prescription from a registered 
veterinarian. 
The veterinarian's prescription shall be made out in at 
least triplicate, at one impression, on a form based on 
the model in Annex I. 
The original shall be kept by the manufacturer or 
dealer; the first copy shall be kept by the stockfarmer 
and when the medicated feedingstuff is supplied the 
manufacturer or dealer shall enter the additional 
particulars provided for on the form. 
The second copy shall be kept by the prescribing 
veterinarian. 
Prescriptions shall be retained by the veterinarian, 
manufacturer or merchant and stockfarmer for at 
least one year from the date of issue and shall be 
made available to the competent supervisory auth­
orities at any time on request. 
2. The veterinarian may prescribe medicated 
feedingstuffs only for animals treated by him, only if 
their use is justified on veterinary grounds and only in 
16.2.82 Official Journal of the European Communities No C 41/7 
such quantities as are necessary for the purpose of the 
treatment. 
3. Member States shall lay down that medicated 
feedingstuffs may not be supplied more than once on 
the same prescription. 
4. Member States may limit the period of validity 
of the veterinary prescription. 
Article 13 
Member States shall take all appropriate measures to 
ensure that medicated feedingstuffs are supplied 
directly by the manufacturer or merchant to the 
stockfarmer. 
CHAPTER V 
Intra-Community trade 
Article 14 
1. Member States shall ensure that there are no 
prohibitions, limitations or obstacles in respect of 
intra-Community trade in medicated feedingstuffs 
which have been manufactured: 
— in accordance with a standard prescription auth­
orized by the Community, 
— in accordance with a prescription from a veteri­
narian, provided that the pre-mix used had been 
authorized by the Community according to 
Directive 81/851/EEC, or 
— in accordance with Article 6 provided that the 
medicated feedingstuff had been authorized by 
the Community, in accordance with the 
abovementioned Directive. 
2. The Community authorizations referred to in 
the first indent of paragraph 1 shall be granted by the 
Commission in accordance with the procedure laid 
down in Article 16. The criteria for the Community 
authorization of standard prescriptions shall be 
determined in accordance with the same procedure. 
A list of such standard prescriptions and all 
amendments thereto shall be published in the Official 
Journal of the European Communities. 
3. Each consignment of a medicated feedingstuff 
must be accompanied by a certificate issued by the 
competent veterinary authority, in accordance with 
the model in Annex II. In the event of manufacture as 
referred to in the second indent of paragraph 1 a veterinary prescription in accordance with Annex I 
shall suffice. 
CHAPTER VI 
Supervision and sanctions 
Article 15 
1. Member States shall take all appropriate 
measures to ensure that their competent authorities 
satisfy themselves through inspection visits that the 
provisions of this Directive are complied with. 
2. Such inspections shall be carried out by 
employees of the competent authorities of the 
Member States, who shall be empowered as a 
minimum to: 
(a) inspect manufacturing and commercial 
establishments and, in cases where the veteri­
narian is authorized to supply medicated 
feedingstuffs direct, the laboratories and work 
premises of veterinary practices; 
(b) inspect the stock farms where medicated 
feedingstuffs are used; 
(c) take samples; 
(d) examine and have at their disposal any documents 
relevant to the object of the inspection; 
(e) require all necessary particulars from the 
interested parties. 
3. Member States shall take all appropriate 
measures to ensure that infringements of this 
Directive are penalized. 
CHAPTER VII 
Final provisions 
Article 16 
1. Where the procedure" laid down in this Article is 
to be used, matters shall be referred by the chairman, 
either on his own initiative or at the request of a 
Member State, to the Standing Veterinary Committee 
(hereinafter called the 'Committee') set up by Council 
Decision 68/361/EEC. 
2. Within the Committee, the votes of Member 
States shall be weighted as provided in Article 148 (2) 
of the Treaty. The chairman shall not vote. 
No C 41/8 Official Journal of the European Communities 16.2.82 
3. The representative of the Commission shall 
submit a draft of the measures to be adopted. The 
Committee shall deliver its opinion on such measures 
within two days. Opinions shall be delivered by a 
majority of 45 votes. 
4. The Commission shall adopt the measures and 
shall apply them immediately where they are in 
accordance with the opinion of the Committee. 
Where they are not in accordance with the opinion of 
the Committee or if no opinion is delivered, the 
Commission shall without delay propose to the 
Council the measures to be adopted. The Council 
shall adopt the measures by a qualified majority. 
If, within three months from the date on which the 
proposal was submitted to it, the Council has not adopted any measures, the Commission shall adopt 
the proposed measures and shall apply them 
immediately. 
Article 17 
Member States shall bring into force the laws, regu­
lations and administrative provisions necessary to 
comply with this Directive not later than 31 January 
1984. They shall forthwith inform the Commission 
thereof. 
Article 18 
This Directive is addressed to the Member States. 
16.2.82 Official Journal of the European Communities No C 41/9 
ANNEX I 
Surname, forename and address of the prescribing veterinarian: Date: 
Copy intended for manufacturer or dealer (') 
(to be retained for at least one year) 
PRESCRIPTION FOR A MEDICATED FEEDINGSTUFF 
Name or business name and address of the manufacturer or dealer: This prescription may not 
be re-used 
Name and address of the stockfarmer:. 
Identification and number of animals: '. 
Indication (2): 
Designation or composition of the medicated feedingstuff: 
Rp 
Total quantity of medicated feedingstuff: kg 
Special instructions for the stockfarmer: 
Percentage of medicated feedingstuff in the daily ration, frequency and duration of treatment: 
Withdrawal time before slaughtering, or waiting time before marketing products from treated 
animals: 
Personal signature of veterinarian 
To be completed by the manufacturer or dealer: 
Date of delivery: 
To be used before: 
Signature of manufacturer or dealer 
(') The following shall be inserted instead of 'the manufacturer or dealer': 
(a) on the first copy the words: 'the stockfarmer', 
(b) on the second copy the words: 'the veterinarian'. 
(2) To be entered only on the copy for the veterinarian. 
No C 41/10 Official Journal of the European Communities 16.2.82 
ANNEX II 
CERTIFICATE OF MANUFACTURE OF A MEDICATED FEEDINGSTUFF FOR THE 
PURPOSES OF INTRA-COMMUNITY TRADE 
(pursuant to Article 14 (3) of Directive .../.. ./EEC on the manufacture, putting into circulation 
and supply of medicated feedingstuffs) 
Name and address of manufacturer or dealer: 
Designation of the medicated feedingstuff: 
Quantity of medicated feedingstuff: 
Name and address of the recipient: 
This is to certify that the abovementioned consignment of medicated feedingstuffs was manufac­
tured in accordance with the provisions of the abovementioned Directive. 
Place and date 
Stamp of the competent veterinary authority 
(Signature) 
Name and position