COMMISSION OF THE EUROPEAN COMMUNITIES 
C0M(93) 587 final 
Brussels, 26 November 1993 
Proposa I for a 
COUNCIL REGULATION (EEC) 
laying down the conditions and arrangements 
for approving certain establishments 
operating in the animal feed sector 
and amending Directives 70/524/EEC and 74/63/EEC 
(presented by the Commission) 
-I-
Explanatory Memorandum 
The draft Council Regulation forms part of the general Community rules and 
regulations on animal feed and, more particularly, the scheme to register 
manufacturers and their representatives. 
At matters currently stand, various directives lay down the minimum 
conditions that manufacturers of additives, premixtures and compound 
feedingstuffs must observe. 
Thus, Council Directives 70/524/EEC on additives in feedingstuffs and 
74/63/EEC on undesirable substances and products in feedingstuffs restrict 
the use and handling of certain materials and products only to those persons 
with the qualifications, facilities and equipment deemed necessary for 
general safety. 
In the light of the experience gained, and in the context of the operation 
of the single market, it is proposed: 
to ensure legal clarity and to improve transparency by setting out the 
conditions and arrangements applying to the approval of the 
establishments in question; 
to update and supplement the criteria that manufacturers, 
intermediaries and their possible representatives must meet; 
to amend Directives 70/524/EEC and 74/63/EEC in accordance with the 
provisions of this draft Regulation. 
As regards subsidiarity, it should be noted that the Member states are 
required to manage the procedures for granting and withdrawing approval and 
to ensure that the obligations laid down are met. 
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As in other cases where highly scientific or technical annexes relating to 
animal or human health are updated, provision should be made for close 
cooperation between the Member States and the Commission in the Standing 
Committee on animal feed established by the Council Decision 70/372/EEC of 
20 July 1970, so that the annex can be amended in line with scientific and 
technical progress. 
3 
Proposal for a 
COUNCIL RFfilllATION fFFfM 
laying down the conditions and arrangements 
for approving certain establishments 
operating in the animal feed sector 
and amending Directives 70/524/EEC and 74/63/EEC 
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 proposai from the Commission^1), 
Having regard to the opinion of the European Par Iiament^2), 
Having regard to the opinion of the Economic and Social Committee^3*, 
Whereas Council Directive 70/524/EEC of 23 November 1970 concerning 
additives in feedingstuffs(4), as last amended by Directive 93/ /EEC(5), 
lays down the minimum conditions to be met by manufacturers of additives, 
premixtures and compound feedingstuffs containing such products; 
Whereas this legislation restricts the manufacture and use of certain 
categories of additives, premixtures and compound feedingstuffs containing 
such additives and premixtures to those manufacturers who are included on a 
nat ional Iist; 
(1) 
(2) 
(3) 
(4) 0J No L 270, 14.12.1970, p. 1. 
(5) 
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Whereas with the operation of the single market in mind, some optional 
provisions which still allow the Member States to derogate from the 
Community provisions applying to the sector in question and to specify the 
criteria for approving manufacturers should be abolished so as to avoid 
distortions of competition caused by the Member States' different 
applications and interpretations of already existing approval conditions and 
to prevent any potentially adverse effects on animals, humans or the 
environment, given the risks inherent in using certain additives. 
whereas, to govern the presence of certain particularly undesirable 
substances in feedingstuffs, Council Directive 74/63/EEC of 17 December 1973 
on the fixing of maximum permitted levels for undesirable substances and 
products in feedingstuffa(&), as last amended by Directive 93/../EEC(7), 
limits their presence in raw materials to an acceptable level; whereas this 
Directive also restricts the use of these raw materials to those persons who 
have the necessary qualifications, facilities and equipment for the dilution 
operations which ensure that the maximum levels laid down in the Directive 
as regards the various types of compound feedingstuffs are complied with; 
Whereas, in the light of the experience gained, additional rules should be 
laid down relating to the registration of establishments engaged in the 
manufacture, storage or packaging of the products in question, and the 
recording of other persons in an official register; 
whereas, with a view to ensuring the quality of the product and preventing 
the risk of residues of certain additives in animal products or of high 
levels of heavy metals or pesticides which might result in the defective 
manufacture of the additives, premixtures or compound feedingstuffs, the 
intention is to approve all manufacturers of additives, premixtures and 
compound feedingstuffs on the basis of standard, specific criteria; 
(6) 0J No L 38, 11.2.1974, p. 31. 
(7) 
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Whereas the obligation on all manufacturers to obtain approval will provide 
the Member States with the opportunity to monitor them and possibly uncover 
and act against those making illegal use of authorized substances or 
employing banned substances such as hormones or p-agonists; 
Whereas the standard obligations which must be complied with to qualify for 
approval should be laid down; whereas it is also necessary to give the 
Commission the task of adopting detailed rules for the application of this 
Regulation, including the imposition of appropriate penalties; 
Whereas, should the Council confer on the Commission responsibility for 
implementing the rules laid down on the conditions and arrangements for 
approving the establishments in question, provision should be made for 
close cooperation between the Member States and the Commission within the 
Standing Committee for Feedingstuffs established by Council 
Decision 70/372/EEC<8); 
Whereas to ensure greater transparency the conditions and arrangements 
relating to approval in the animal feed sector should be brought together in 
a single text; whereas this entails adapting existing legislations; 
Whereas the Member states are responsible for ensuring that the minimum 
conditions for national authorities to grant approval as set out in this 
Regulation are met and that the establishments subsequently continue to 
comply with the said conditions; whereas, however, these provisions must 
apply without prejudice to the Community rules governing the organization of 
official checks on animal feed; 
Whereas it is necessary to adopt these measures at Community level in order 
to better achieve the objectives of guaranteeing the quality and safety of 
animal feedingstuffs, 
(8) OJ No L 170, 3.8.1970, p. 1 
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HAS ADOPTED THIS REGULATION: 
Article 1 
1. This Regulation lays down the conditions and arrangements for approving 
certain categories of establishments in the animal feed sector, 
hereinafter referred to as "establishments", which must meet the 
conditions laid down in Article 3 below with a view to the marketing of 
the products in question. 
2. This Regulation shall apply without prejudice to the Community 
provisions concerning the organization of official checks on animal 
feed. 
3. For the purposes of this Regulation, the definitions laid down in 
Community legislation on animal feed shall apply where necessary. 
Article 2 
From .../.../19..., the establishments shall apply for inclusion in an 
official register held by the competent national authority with a view to 
being approved by the Member State. 
Article 3 
1. To be approved by the competent national authorities an establishment 
(a) manufacturing additives must meet the conditions listed in 
Chapter I of the Annex; 
(b) engaged in the manufacture, storage or packaging of premixtures 
must meet the conditions listed in Chapter II of the Annex; 
(c) engaged in the manufacture, storage or packaging of compound 
feedingstuffs containing premixtures must meet the conditions 
listed in Chapter III A of the Annex; 
(d) manufacturing compound feedingstuffs from raw materials 
(ingredients) containing high levels of undesirable products or 
substances must meet the conditions listed in Chapter III B of 
the Annex; 
-}-
(e) manufacturing compound feedingstuffs must meet the conditions 
listed in chapter III C of the Annex. 
2. The amendments that need to be made to the Annex by virtue of 
scientific and technological progress shall be adopted in accordance 
with the procedure laid down in Article 11. 
Article 4 
Article 1 notwithstanding, manufacturers of compound feedingstuffs who use 
premixtures or raw materials containing high levels of undesirable 
substances and products with a view to their proper consumption may apply 
for approval in accordance with this Regulation. To be eligible for such 
approval, they must meet the conditions laid down in Article 3(1)(c) or (d) 
and set out in Chapters IIIA or IIIB, with the exception however of the 
requirements laid down in point 7. 
Article 5 
Where the additive is an antibiotic, coccidiostat or another medicinal 
substance listed in Groups A or D of the Annexes to Directive 70/524/EEC and 
already authorized for manufacture as a veterinary medication within the 
meaning of Article 24 of Directive 81/851/EEC, the conditions laid down in 
Article 3(1)(a) and contained in chapter I of the Annex to this Regulation 
shall not apply, with the exception however of the requirements stipulated 
in points 3, 5, 6.2 and 7. 
Article 6 
1. For each activity, the competent national authority shall enter the 
establishments in the official register referred to in Article 2 under 
an individual registration number which identifies them, once it has 
established that they satisfy the conditions laid down by this 
Regulation. 
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2. The Member States shall update the official register and correct or 
replace, where necessary, any entry where an establishment decides to 
engage in activities which are in addition to or replace those for 
which it was initially registered. 
Article 7 
The practical arrangements for approving establishments located in a 
non-member country and putting animal feedingstuffs, additives or 
premixtures into circulation within the Community shall be adopted in 
accordance with the procedure laid down in Article 11. 
Article 8 
Each Member State shall publish each year, and by 30 November at the latest, 
a list of the establishments and representatives approved in accordance with 
Articles 3 and 7 which it has found to comply with the requirements listed 
in the Annexes hereto. 
The Member state shall send the list to the other Member States and to the 
Commission before 31 December of each year. 
Any amendments made to the lists after 30 November shall be separately 
notified to the other Member States and to the Commission. 
Article 9 
Detailed rules for the application of this Regulation shall be adopted in 
accordance with the procedure laid down in Article 11. 
Article 10 
The Commission shall be assisted by the Standing Committee for 
Feedingstuffs, established by Council Decision 70/372/EEC of 20 July 1970, 
hereinafter referred to as "the Committee". 
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Article 11 
Where the procedure laid down in this Article is to be followed, the 
following provisions shall apply: 
The representative of the Commission shall submit to the Committee a draft 
of the measures to be taken. The Committee shall deliver its opinion on the 
draft within a time limit which the chairman may lay down depending on the 
urgency of the matter, with a vote being taken, where appropriate. 
The opinion shall be recorded in the summary record. Each Member State 
shall also have the right to request that its position be recorded in the 
summary record. 
The Commission shall take full note of the Committee's opinion. It shall 
inform the Committee of the way in which it took account thereof. 
Article 12 
Council Directive 70/524/EEC of 23 November 1970 concerning additives in 
feedingstuffs is hereby amended as follows: 
1. Article 13(1) is replaced by the following: 
"1. Member states shall require that antibiotics, coccidiostats and 
other medicinal substances, growth promoters, trace elements 
and vitamins listed in Annex I or Annex II, premixtures 
prepared from these additives with a view to being incorporated 
in compound feedingstuffs and compound feedingstuffs containing 
these premixtures may only be put on the market under the 
conditions referred to in the Annex to Regulation (EEC) 
No .../... and in particular only if they have been produced 
by manufacturers who have been approved in accordance with the 
provisions of the said Regulation." 
2. The reference to Annex III in Article 13(2) is replaced by a reference 
to the Annex to Regulation (EEC) No .../... 
3. Article 13(3) is deleted. 
4. Paragraph 4 of Article 13 becomes paragraph 3. 
5 Article 13(5) is deleted. 
6. Annex III is deleted. 
Article 13 
council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum 
permitted levels for undesirable substances and products in feedingstuffs is 
hereby amended as follows: 
Point (a) of Article 3a(2) is replaced by the following: 
"(a) it is intended for use by manufacturers of compound feedingstuffs 
entered on a national list in accordance with the provisions of 
Regulation (EEC) No .../... and meeting the requirements set out in 
chapter III B of the Annex and" 
Article 14 
This Regulation shall enter into force twelve months following its 
publication in the Official Journal of the European Communities. 
This Regulation shall be binding in its entirety and directly applicable in 
all Member States. 
Done at For the Council 
The President 
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ANNEX 
Chapter I. Conditions which must be fulfilled by establishments 
manufacturing additives in order to obtain approval 
1« Facilities and Equipment 
Facilities and manufacturing equipment shall be located, designed, 
constructed, adapted and maintained to suit the manufacture of 
additives. The lay-out, design and operation of the facilities and 
equipment must minimize the risk of error and permit effective 
cleaning and maintenance in order to avoid contamination, cross-
contamination by other products and any adverse effects generally on 
the quality of the products. 
Facilities and equipment to be used for manufacturing operations which 
are essential for the quality of the products shall undergo 
appropriate and regular checks, in accordance with the written 
procedures. 
2. Personnel 
The manufacturer or his staff must possess the knowledge and 
experience necessary for the manufacture of additives. 
3. Production 
The manufacturer must ensure that the additives conform to 
Directive 70/524/EEC and that all manufacturing operations are carried 
out in accordance with the information given in the application. A 
qualified person responsible for production must be designated. 
The different stages in production shall be carried out according to 
pre-established written instructions and procedures. Measures shall be 
taken to avoid cross-contamination and errors. The critical stages in 
the manufacturing process shall be regularly checked, in accordance 
with the written procedures. 
-<2 -
4. Quality control 
The manufacturer shall establish and maintain a quality control 
laboratory to carry out the necessary examination and analysis of raw 
materials, packaging materials and intermediate and finished products 
testing. A qualified person responsible for quality control shall be 
designated. 
Before releasing the finished products for sale or distribution, their 
compliance with the specifications as supplied with the application 
for authorization must be checked and guaranteed. 
Samples of the active substance and of each batch of finished product 
shall be retained in order to ensure traceability. 
5. Storage 
Additives shall be stored in such a way as to to be easily identified 
and to avoid any confusion with other products. They shall be stored 
in suitable places to which only authorized persons have access. 
6. Documentation 
6.1 Documentation of manufacturing process and controls 
The manufacturer must have a system of documentation based upon 
specifications, manufacturing formulae, processing and packaging 
instructions, procedures and the various summary sheets and records 
covering the different manufacturing operations performed. This set 
of documents shall make it possible to trace the manufacturing history 
of each batch produced and to establish responsibility when complaints 
arise. 
6.2 Commercial register 
The manufacturer must record the following information to facilitate 
traceability : the nature and quantity of the additives produced, the 
respective dates of manufacture and batch number if appropriate and 
the names and addresses of the approved manufacturers of premixtures 
or approved intermediaries to whom the additives have been delivered, 
along with an indication of the nature and quantity of additives 
delivered and batch number, if appropriate. 
-13 -
7. Commercial Intermediaries 
Where the manufacturer delivers additives to a person other than an 
approved manufacturer of premixtures, that person and any subsequent 
intermediary shall be equally bound by the obligations laid down in 
points 5 and 6.2. 
8. Complaints and product recall 
The manufacturer shall implement a system for recording and dealing 
with complaints, together with an effective system for recalling 
promptly and at any time the products in the distribution network. 
Where there is a risk to human health, the authorities must be 
informed. Any goods returned must be reassessed and approved by 
quality control before being resold, where appropriate. 
chapter II. Conditions which must be fulfilled by establishments 
manufacturing premixtures in order to obtain approval 
1. Facilities and Equipment 
Facilities and manufacturing equipment shall be located, designed, 
constructed, adapted and maintained to suit the manufacture of 
premixtures. The lay-out, design and operation of both facilities and 
equipment must minimize the risk of error and permit effective 
cleaning and maintenance in order to avoid contamination, cross-
contamination and any adverse effects generally on the quality of the 
products. Facilities and equipment to be used for manufacturing 
operations which are essential for the quality of the products shall 
undergo appropriate and regular checks, in accordance with the written 
procedures. 
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
2. Personnel 
The manufacturer or his staff must possess the knowledge and 
experience necessary for the manufacture of premixtures. 
-14 -
3. Production 
A qualified person responsible for production must be designated. The 
different stages in production shall be carried out according to 
pre-established written instructions and procedures. Measures shall be 
taken to avoid cross-contamination and errors. The critical stages in 
the manufacturing process shall be regularly checked in accordance 
with the written procedures: incorporation, chronological order of 
production, meters and weighing apparatus, mixer, returns. 
4. Quality control 
The manufacturer must guarantee and verify the nature, content, 
uniformity and stability of the additives in the premixture. A 
quality control plan must be established and implemented with a view 
to achieving this goal. A qualified person responsible for quality 
control must be designated. 
samples of the finished product shall be kept in order to ensure 
traceability. 
5. Storage 
The additives and premixtures shall be stored in such a way as to be 
identifiable and to avoid confusion with other products. They shall be 
stored in suitable places to which only authorized persons have 
access. 
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
6. Documentation 
6.1 Documentation of manufacturing process and controls 
The manufacturer must have a system of documentation based on 
specifications, manufacturing formulae, processing and packaging 
instructions, procedures and the various summary sheets and records 
covering the different manufacturing operations performed. This set 
of documents shall make it possible to trace the manufacturing history 
of each batch produced and to establish responsibility when complaints 
arise. 
-15 -
6.2 Commercial register 
The manufacturer must record the following information in order to 
ensure traceability : the name of the approved manufacturers and 
suppliers, the nature and quantity of the additives used and batch 
number if appropriate, the date of manufacture, the name and address 
of the approved compound feedingstuff manufacturers or intermediaries 
for whom the premixture is intended and the nature and quantity of the 
premixture delivered. 
7. Commercial intermediaries 
Where the manufacturer delivers premixtures to a person other than an 
approved manufacturer of compound feedingstuffs, that person and any 
subsequent intermediary shall be equally bound by the obligations laid 
down in points 5 and 6.2. 
8. Complaints and product recall 
The manufacturer shall implement a system for recording and dealing 
with complaints, together with an effective system for recalling 
promptly and at any time the products in the distribution network. 
Where there is a risk to human health, the authorities must be 
informed. Any goods returned must be reassessed and approved by 
quality control before being resold, where appropriate. 
chapter III. conditions which must be fulfilled by establishments 
manufacturing compound feedingstuffs in order to obtain 
approval 
III.A : Conditions which must be fulfilled by establishments 
manufacturing compound feedingstuffs containing the premixtures 
referred to in chapter II, in order to obtain approval. 
-16 -
1. Facilities and Equipment 
Facilities and manufacturing equipment shall be located, designed, 
constructed, adapted and maintained to suit the manufacture of 
compound feedingstuffs containing premixtures. The lay-out, design and 
operation of the facilities and equipment must be such as to minimize 
the risk of error and permit effective cleaning and maintenance in 
order to avoid contamination, cross-contamination and any adverse 
effects generally on the quality of the products. 
Facilities and equipment to be used for manufacturing operations which 
are essential for the quality of the products shall undergo the 
appropriate checks in accordance with the written procedures. 
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
2. Personnel 
The manufacturer or his staff must possess the knowledge and have the 
appropriate experience for the manufacture of compound feedingstuffs 
containing premixtures. 
3. Production 
A qualified person responsible for production must be designated. The 
different stages in production shall be carried out according to 
pre-established written instructions and procedures. Measures shall be 
taken to avoid cross-contamination and errors. Critical stages in the 
manufacturing process shall be regularly checked in accordance with 
the written procedures: incorporation, chronological order of 
production, meters and weighing apparatus, mixer, returns. 
-17 -
4. Quality control 
The manufacturer must guarantee and verify the nature, content, 
uniform mix of the additives in the premixture. A quality control 
plan must be established and implemented with a view to achieving this 
goal. A qualified person responsible for quality control must be 
designated. 
The various analytical components must be checked for conformity with 
Directive 79/373/EEC by means of a quality control plan and 
appropriate methods. 
Samples of the finished product shall be kept in order to ensure 
traceability. 
5. Storage 
The premixtures and/or additives shall be stored in such a way as to 
be identifiable and to avoid confusion with other products. They shall 
be stored in suitable places to which only authorized persons have 
access. 
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
6. Documentation 
6.1 Documentation of the manufacturing process and controls 
The manufacturer shall have a system of documentation based on 
specifications, manufacturing formulae, processing and packaging 
instructions, procedures and the various summary sheets and records 
covering the different manufacturing operations performed. This set 
of documents shall make it possible to trace the manufacturing history 
of each batch processed and establish responsibility when complaints 
arise. 
-18 -
6.2 Commercial register 
The manufacturer must record the following information in order to 
ensure traceability : the name of the approved premixture supplier and 
approved manufacturer if he is not the supplier, the batch number if 
appropriate, the nature and quantity of the premixture and the use to 
which it will be put. 
7. Complaints and product recall 
The manufacturer shall implement a system for recording and dealing 
with complaints, together with an effective system for recalling 
promptly and at any time the products in the distribution network. 
Where there is a risk to human health, the authorities must be 
informed. Any goods returned must be reassessed and approved by 
quality control before being resold, where appropriate. 
Ill B. Conditions which must be fulfilled by establishments 
manufacturing compound feedingstuffs from raw materials 
containing high levels of undesirable substances and products 
1. Facilities and Equipment 
Facilities and manufacturing equipment shall be located, designed, 
constructed, adapted and maintained to suit the manufacture of 
compound feedingstuffs from raw materials containing high levels of 
undesirable substances and products. The lay-out, design and operation 
of the facilities and equipment must be such as to minimize the risk 
of errors and permit effective cleaning and maintenance in order to 
avoid contamination, cross-contamination and any adverse effects 
generally on the quality of the products. 
Facilities and equipment to be used for manufacturing operations which 
are essential for the quality of the products shall undergo the 
appropriate checks in accordance with the written procedures. 
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
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2. Personnel 
The manufacturer or his staff must possess the knowledge and have the 
necessary experience for the manufacture of compound feedingstuffs 
from raw materials containing high levels of undesirable substances 
and products. 
3. Production 
A qualified person responsible for production must be designated. The 
different stages in production shall be carried out according to 
pre-established written instructions and procedures. Measures shall be 
taken to avoid cross-contamination and errors. The critical stages in 
the manufacturing process shall be regularly checked in accordance 
with the written procedures: incorporation, chronological order of 
production, meters and weighing apparatus, mixer, returns. 
4. Quality control 
The manufacturer must guarantee and verify the nature, content, and 
uniform mix of the undesirable products and substances in the compound 
feedingstuff. A quality control plan must be established and 
implemented to achieve this goal and to comply with the maximum limits 
permitted in compound feedingstuffs. A qualified person responsible 
for quality control must be designated. 
The various analytical components must be checked for conformity with 
Directive 79/373/EEC by means of a quality control plan and 
appropriate methods. 
Samples of the finished product shall be kept in order to ensure 
traceability. 
5. Storage 
The raw materials and the compound feedingstuffs shall be stored in 
such a way as to be identifiable and to avoid confusion with other 
products. They shall be stored in suitable places to which only 
authorized persons have access. 
- JLO -
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
6. Documentation 
6.1 Documentation of the manufacturing process and controls 
The manufacturer shall have a system of documentation based on 
specifications, manufacturing formulae, processing and packaging 
instructions, procedures and the various summary sheets and records 
covering the different manufacturing operations performed. This set 
of documents shall make it possible to trace the manufacturing history 
of each batch produced and establish responsibility when complaints 
arise. 
6.2 Commercial register 
The manufacturer must record the following information in order to 
ensure traceability : the name of the supplier of raw materials 
containing high levels of undesirable substances and products and the 
name of the manufacturer if he is not the supplier, the nature and 
quantity of undesirable substances and products and the use to which 
they will be put. 
7. Complaints and product recall 
The manufacturer shall implement a system for recording and dealing 
with complaints, together with an effective system for recalling 
promptly and at any time the products in the distribution network, 
where there is a risk to human health, the authorities must be 
informed. Any goods returned must be reassessed and approved by 
quality control before being resold, where appropriate. 
- XI -
III C. Conditions which must be fulfilled by establishments 
manufacturing compound feedingstuffs in order to obtain approval 
1. Facilities and Equipment 
Facilities and manufacturing equipment shall be located, designed, 
constructed, adapted and maintained to suit the manufacture of 
compound feedingstuffs. The lay-out, design and operation of the 
facilities and equipment must be such as to minimize the risk of error 
and permit effective cleaning and maintenance in order to avoid 
contamination, cross-contamination and any adverse effects generally 
on the quality of the products. 
Facilities and equipment to be used for manufacturing operations which 
are essential for the quality of the products shall undergo the 
appropriate checks. 
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
2. Personnel 
The manufacturer or his staff must possess the knowledge and have the 
appropriate experience for the manufacture of compound feedingstuffs. 
3. Production 
A qualified person responsible for production must be designated. The 
different stages in production shall be carried out according to 
pre-established written instructions and procedures. The critical 
stages in the manufacturing process must be checked: incorporation, 
meters and weighing apparatus, mixer. 
4. Quality control 
The manufacturer must have the means to guarantee and verify the 
uniform mix of the ingredients in the compound feedingstuff. The 
various analytical components must be checked for conformity with 
Directive 79/373/EEC by means of a quality control plan and 
appropriate methods. A qualified person responsible for quality 
control must be designated. 
- 22 -
storage 
The raw materials and the compound feedingstuffs shall be stored in 
such a way as to be identifiable and to avoid confusion with other 
products. They shall be stored in suitable places. 
There must be a prevention scheme and regular control measures must be 
applied to prevent the entrance of rodents, insects, birds and 
domestic animals as far as possible. 
2-S 
KSN 0254-1475 
COM(93) 587 final 
DOCUMENTS 
EN 03 
Catalogue number : CB-CO-93-624-EN-C 
ISBN 92-77-61647-4 
Office for Officiai Publications of the European Communities 
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