EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANCO/12328/2013 Rev. 4 ANNEX (POOL/G1/2013/12328/12328R4-EN 
ANNEX.doc) 
[…](2014) XXX  draft 
ANNEXES 1 to 6 
  
ANNEXES 
to the Proposal 
for a 
REGULATION OF THE EUROPEAN PA RLIAMENT AND OF THE COUNCIL 
on the manufacture, placing on the market and use of medicated feed and repealing 
Council Directive 90/167/EEC 
 EN 2   EN ANNEX I  
Requirements for feed business operato rs, as referred to in Article 3 
SECTION 1 
FACILITIES AND EQUIPMENT 
Feed business operators shall use facilities and equipment that satisfy the following 
requirements. 
1. Facilities and equipment and their immedi ate surroundings shall be kept clean and 
effective pest control programmes shall be implemented. Cleaning programmes shall 
be introduced. Those programmes shall en sure that any contamination, including 
from residues of detergents and biocid es, and any cross-contamination, including 
resulting from carry-over, are minimised. 
2. The lay-out, design, construction and size of  the facilities and equipment shall be 
such as to:  
(a) minimise the risk of errors and to a void any adverse effects generally on the 
safety and quality of the products; 
(b) allow adequate cleaning and disinfection;  
(c) allow the machinery coming into contact with feed to be dried following any 
wet cleaning process.  
3. Facilities and equipment to be used fo r manufacturing shall unde rgo appropriate and 
regular checks, in accordance with written procedures pre-established by the manufacturers of the equipment.  
All scales and metering devi ces shall be appropriate for the range of weights or 
volumes to be measured and shall be  tested for accuracy regularly.  
All mixers shall be appropriate for the ra nge of weights or volumes being mixed, and 
shall be capable of manufacturing suita ble homogeneous mixtures. Operators shall 
demonstrate the effectiveness of mi xers with regard to homogeneity.  
4. Facilities shall have adequate natural or artif icial lighting.  
5. Drainage facilities shall be adequate for the purpose intended; they shall be designed 
and constructed to avoid the risk  of contamination of feed.  
6. Water used in manufacture shall be of suita ble quality for animals; the conduits for 
water shall be of an inert nature.  
7. Sewage, waste and rainwater shall be dis posed of in a manner which ensures that 
equipment and the safety and quality of medi cated feed and intermediate products is 
not affected.  
8. Where appropriate, temperatures shall be  kept as low as possible to avoid 
condensation and spoilage. 
9. Spoilage and dust shall be contro lled to prevent pest invasion.  
10. Windows and other openings shall, where n ecessary, be proven against pests. Doors 
shall be close-fitting and proven against pests when closed.  
11. Where necessary, ceilings and overhead fixt ures shall be designed, constructed and 
finished to prevent the accumulation of di rt and to reduce condensation, the growth EN 3   EN of undesirable moulds and the shedding of pa rticles that can affect the safety and 
quality of medicated feed a nd intermediate products.  
SECTION 2 
PERSONNEL 
1. Feed business operators shall have sufficient staff possessing the skills and 
qualifications necessary for the manufacture of the produc ts concerned. All the staff 
shall be informed clearly in writing of their duties, responsibilities and powers, 
especially when any change is made, in such a way as to obtain the desired product quality.  
A qualified person responsible for the manufacture of medicated feed and 
intermediate products and a qua lified person respons ible for quality control shall be 
designated. 
2. An organisation chart setting out the qua lifications and res ponsibilities of the 
supervisory staff shall be drawn up and made  available to the competent authorities 
in case of an inspection.  
SECTION 3 
MANUFACTURE 
1. Feed business operators sha ll ensure that the different  stages of production are 
carried out in accordance with pr e-established written procedures. 
2. Technical or organisational m easures shall be taken to avoid any cross-contamination 
and errors, to carry out checks in the course  of manufacture and to ensure effective 
tracing of the products used for the manuf acture of medicated feed and intermediate 
products.  
3. The presence of undesirable substances w ithin the meaning of Directive 2002/32/EC 
and of other contaminants in relation to human and animal health shall be monitored, 
and appropriate measures to minimise this presence shall be taken. 
4. The products used for the manufacture and unprocessed feed shall be stored 
separately from medicated feed and inte rmediate products in order to avoid any 
cross-contamination. 
5. Waste and other materials not intended for feed use should be se parated, adequately 
labelled and used or disposed of in an  appropriate way and not used as feed.  
SECTION 4 
QUALITY CONTROL 
1. Feed business operators shall,  as part of a quality control system, have access to a 
laboratory with adequate staff and equipment.  
2. A quality control plan shall be drawn up in writing and implemented. It shall include, 
in particular, checks on the critical poi nts in the manufacturing process, sampling 
procedures and frequencies, methods of analysis and their frequency, compliance 
with the specifications from processed materials to final products and the measures to be taken in the event of non-compliance.  
3. Specific regular own checks shall ensure compliance with the homogeneity criteria 
as laid down in accordance w ith Article 6(2), the limits for carry-over as laid down in 
accordance with Article 7(2) and the minimu m storage life of the medicated feed. EN 4   EN 4. Samples of the products used for manufact uring medicated feed and intermediate 
products and of each batch of medicated f eed and intermediate products shall be 
taken in sufficient quantity in accordance w ith a pre-established sampling plan in 
order to ensure traceability. The samples shall be sealed and labelled for easy identification and stored under conditions which prevent any abnormal change in the composition of the sample or any adulteration. They shall be kept at the disposal of 
the competent authorities for a period appropr iate to the use for which the medicated 
feed or intermediate product is placed on the market.  
SECTION 5 
STORAGE AND TRANSPORT 
Medicated feed and intermediate  products shall be stored in suitable separate and secured 
rooms to which only persons authorised by the f eed business operators have access, or sealed 
in hermetic containers which are specially de signed for the storage of such products. They 
shall be stored in places desi gned, adapted and maintained in  order to ensu re good storage 
conditions.  
Medicated feed and intermediate products shall be stor ed and transported in such a way as to 
be easily identifiable. Medicate d feed and intermediate products shall be transported in 
suitable means of transport. 
SECTION 6 
RECORD-KEEPING 
1. Feed business operators manufacturing, st oring, transporting or placing on the 
market medicated feed and intermediate pr oducts shall keep in a register relevant 
data, comprising details of purchase, manuf acturing, storage, transport and placing 
on the market for effective tracing from r eceipt to delivery, including export to the 
final destination. 
2. The register referred to in paragraph 1 shall contain:  
(a) the HACCP documentation referred to in  Article 6(2)(g) of Regulation (EC) 
No 183/2005,  
(b) the quality control plan and the re sults of the relevant controls,  
(c) specifications and quantities of veterina ry medicinal products, feed materials, 
compound feed, feed additives, intermediate products and medicated feed which have been purchased,  
(d) specifications and quantities of the batche s of medicated feed and intermediate 
products which have been manufactured, including the veterinary medicinal 
products, feed materials, compound feed, feed additives and intermediate products which have been used, 
(e) specifications and quantities of the batche s of medicated feed and intermediate 
products which have been stored or transported, 
(f) specifications and quantities of medica ted feed and intermediate products 
which have been placed on the market  or exported to third countries, 
(g) information on the manufacturers or s uppliers of the medicated feed and 
intermediate products or of  the products used for the manufacture of medicated 
feed and intermediate products, includi ng at least their name, address and, 
where applicable, their a pproval identifying number, EN 5   EN (h) information on the recipients of the me dicated feed and intermediate products, 
including at least their name, addre ss and, where applicable, their approval 
identifying number and  
(i) information on the person who has issued  the prescription, including at least 
his name and address. 
Apart from the documents that are permanent in nature, the documents shall be kept 
for three years in the register after their date of issuance.  
SECTION 7 
COMPLAINTS AND PRODUCT RECALL 
1. Feed business operators plac ing medicated feed and inte rmediate products on the 
market shall implement a system for re gistering and processing complaints.  
2. They shall put in place, a system for th e prompt withdrawal from the market of 
medicated feed or intermediate products and, if necessary, for the recall from the distribution network of products in case they  prove not to satisfy the requirements of 
this Regulation. They shall define by means of written procedures the destination of 
any recalled products, and before such produc ts are put back into circulation they 
shall undergo a quality-control reassessment. EN 6   EN ANNEX II  
Incorporation of the veterinary medicinal product into the feed as referred to in 
Article 5(2)(a)  
1. Mobile mixers or on-farm mixers shall on ly use veterinary me dicinal products at 
inclusion rates above 2 kg/t of feed. 
2. The daily dose of the veterinary medicinal product shall be incorporated in a quantity 
of medicated feed that ensures the uptake of the daily dose by the target animal 
considering that the feed upt ake of diseased animals might differ from a normal daily 
ration. 
3. Medicated feed containing the daily dose of  the veterinary medicinal product shall 
correspond to at least 50% of the daily feed ration on a dry matter basis. For 
ruminants, the daily dose of the veterinary medicinal produc t shall be contained in at 
least 50% of the complementary feed except for mineral feed. EN 7   EN ANNEX III  
Labelling particulars as referred to in Article 9(1)  
The label of medicated feed and intermediate products shall include the following particulars: 
(1) the expression 'Medicated feed' or 'Intermediate product for medicated feed' 
supplemented by the expression 'complete' or  'complementary', as appropriate, and 
the target species; 
(2) the name or business name and the addre ss of the feed business operator responsible 
for the labelling; 
(3) the approval number of the person respons ible for the labelling in accordance with 
Article 12;  
(4) the batch reference number of the medicated feed or intermediate product; (5) the net quantity of medicated feed expre ssed in units of mass in the case of solid 
feed, and in units of mass or vol ume in the case of liquid feed; 
(6) the veterinary medicina l products with name, active substance, strength, added 
amount, marketing authorisation holder and marketing authorisation number, 
preceded by the heading ‘medication’; 
(7) therapeutic indications of the veterinary  medicinal products, any contra-indications 
and adverse events in so far as these particulars are necessary for the use; 
(8) in the case of a medicated feed or of  intermediate produc t intended for food-
producing animals, the withdrawal period or the indication ‘none’;  
(9) a recommendation to read the package l eaflet of the veterinary medicinal products, 
including a hyperlink where it can be f ound, a warning that the product is only for 
the treatment of animals and a warning that the product must be kept out of the sight 
and reach of children; 
(10) the list of feed additives, preceded by the heading 'additives', contained in medicated 
feed for food-producing animals in accordan ce with Chapter I of Annex VI to 
Regulation (EC) No 767/2009 or in case of medicated feed for non-food producing 
animals in accordance with Chapter I of Annex VII to that Regulation and, if 
applicable, the labelling requirements laid  down in the respective feed additive 
authorisation act; 
(11) the name(s) of the feed materials as  listed in the Catalogue referred to in 
Article 24(1) of Regulation (EC) No 767/ 2009 or in the register referred to in 
Article 24(6) of that Regulation. Where se veral feed material s are used for the 
manufacture, they shall be listed in acco rdance with the provisions laid down in 
Article 17(1)(e) and (2) of Regulation (EC) No 767/2009; 
(12) the analytical constitu ents of medicated feed fo r food-producing animals in 
accordance with Chapter II of Annex VI to Regulation (EC) No 767/2009 or in accordance with Chapter II of Annex VII to  that Regulation in case of medicated 
feed for non-food producing animals; 
(13) in case of medicated feed for non-food producing animals, a free telephone number 
or other appropriate means of communication in order to  allow the purchaser to 
obtain, in addition to the mandatory partic ulars, information on the feed additives 
contained in the medicated feed or on the feed materials contained in the medicated EN 8   EN feed where they are designated by category as provided for in Article 17(2)(c) of 
Regulation (EC) No 767/2009; 
(14) the moisture cont ent if it exceeds 14 %; 
(15) the instructions for use in line with th e veterinary prescription and the summary of 
the product characteristics referred to  in Article 14 of Directive 2001/82/EC; 
(16) the minimum storage life considering the stability of the feed additives and the 
veterinary medicinal products and speci al storage precautions, if appropriate. EN 9   EN ANNEX IV  
Permitted tolerances for the compositional la belling of medicated feed or intermediate 
products as referred to in Article 9(3) 
1. The tolerances laid down in this point shall include technical and analytical 
deviations.  
Where the composition of a medicated feed or an intermediate  product is found to 
deviate from the amount of an antimicrobial  active substan ce indicated on the label, a 
tolerance of 10% shall apply. For the other active substances, the following tolerances shall apply: 
Active substance  per kg of medicated feed Tolerance  
> 500 mg ± 10% 
> 10 mg and ≤ 500 mg ± 20% 
> 0,5 mg and ≤ 10 mg ± 30% 
≤ 0,5 mg ± 40% 
2. For the labelling particulars referred to  in points 10 and 12 of Annex III to this 
Regulation, the tolerances laid down in Annex IV to Regulation (EC) No 767/2009 
shall apply, as appropriate.  EN 10   EN ANNEX V  
Prescription form as referred to in Article 15(2) 
"PRESCRIPTION FOR MEDICATED FEED 
1. Surname, forename, address and professi onal membership number of the person 
allowed to prescribe a veterinary medicinal product. 
2. Issue date and signature or  electronic identification of the person allowed to 
prescribe a veterinary medicinal product. 
3. Name and address of the animal holder. 
4. Identification and number of animals. 
5. Diagnosed disease to be treated. 
6. Designation of the veterinary medicinal pr oduct(s), including the name of the active 
substance(s). 
7. If prescribed under Articles 10 and 11 of Di rective 2001/82/EC, a statement to this 
effect. 
8. Inclusion rate of the veterinary medicinal product(s) (quantity per weight unit of 
medicated feed). 
9. Quantity of medicated feed. 
10. Instructions for use for the animal holder,  including the durati on of the treatment. 
11. Percentage of medicated feed in the daily  ration or quantity of medicated feed per 
animal and day. 
12. If applicable, withdrawal pe riod before placing on the market products from treated 
animals. 
13. Any appropriate warnings. 
14. For food-producing animals, the mention 't his prescription sha ll not be re-used'. 
15. The following mentions to be completed by th e supplier of the medicated feed or the 
on-farm mixer, as appropriate:  
– name or business name and address; 
– date of delivery or of on-farm mixing. 
16. Signature of supplier or of on-farm mixer." EN 11   EN ANNEX VI  
Correlation table referred to in Article 22 
Directive 90/167/EEC This Regulation 
Article 1 Article 1 
Article 2 Article 2 
Article 3(1) Article 5(1) 
Article 3(2) - 
Article 4(1) Articles 3, 4, 5(2), 6, Annexes I and II 
Article 4(2) - 
Article 5(1) Article 10 
Article 5(2) Articles 3, 7 and Annex I 
- Article 8 
Article 6 Article 9 and Annex III 
Article 7 - 
Article 8(1) Article 15 
Article 8(2) - 
Article 8(3) Article 16(3) 
Article 9(1) Article 12 and 16(1) 
Article 9(2) - 
Article 9(3) - 
Article 10 Article 11 
- Article 13 
- Article 14 
- Article 16(2) 
- Article 16(4) 
- Article 17 
Article 11 - 
Article 12 Article 18 
- Article 19 
- Article 20 
- Article 21 
- Article 22 
- Article 23 
Article 13 - 
Article 14 - EN 12   EN Article 15 - 
Article 16 - 
Annex A Annex V 
Annex B - 
- Annex IV