Proposal 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
Date: 1993-11-26
Institutions: European Commission
Subjects: animal nutrition, food additive, food industry, health control, marketing, product quality

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. 

-,  2 -

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) 

- v-

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) 

- s -

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 

HAS ADOPTED THIS REGULATION: 

-  y  -

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. 

-s -

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". 

- 

<\-

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 

-  l l-

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. 

4.  Quality control 

-<2 -

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. 

7.  Commercial  Intermediaries 

-13 -

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. 

3.  Production 

-14 -

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. 

6.2  Commercial register 

-15 -

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. 

1.  Facilities and Equipment 

-16 -

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. 

4.  Quality control 

-17 -

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. 

6.2  Commercial register 

-18 -

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. 

2. 

Personnel 

-19 -

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. 

III C. 

Conditions 

which 

must 

be 

fulfilled 

by 

establishments 

manufacturing compound  feedingstuffs in order to obtain approval 

- XI -

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. 

storage 

-  22 

-

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 
L-2985 Luxembourg