Proposal for a European Parliament and Council Directive amending Council Directive 95/69/EC laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector
Date: 1997-07-25
Institutions: European Commission
Subjects: adjuvant, animal nutrition, health control, manufactured feedingstuffs, marketing

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 25.07.1997 
COM(97) 409 final 

97/ 0213 (COD) 

Proposal for a 

EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE 

amending Council Directive 95/69/EC 

laying down the conditions and arrangements for approving 

and registering certain establishments and intermediaries 

operating in the animal feed sector 

(presented by the Commission) 

Explanatory Memorandum 

Directive ../.../EC1 amending Directive 93/74/EEC on feedingstuffs  intended for particular 
nutritional purposes2 extends the scope of Directive 93/74/EEC to cover a new generation 

of products called "nutritional supplements for animals". 

Nutritional supplements are similar in composition to premixtures of additives. 

Therefore,  with  regard  to  manufacturing  conditions,  establishments  manufacturing 

nutritional supplements for animals and their intermediaries should be subject"to the same 

rules  as  those  laid  down  in  Directive  95/69/EC 

for  approving  establishments 

manufacturing premixtures. 

It is also necessary to provide for the registration of users of nutritional  supplements  for 

animals,  i.e.  livestock  farmers,  to  ensure  that  they  possess  the  necessary  facilities  for 

making appropriate use of the products in question on the farm. 

The scope of this proposal is restricted to laying down the rules which Member States must 

follow  when  approving  or  registering  establishments  and  intermediaries  manufacturing 

nutritional supplements for animals; 

It is necessary to adopt these measures at Community level in order better to achieve the 

objectives of guaranteeing the quality and safety of  feedingstuffs. 

OJNoL 
OJ No L 237, 22.9.1993, p. 23. 
OJ No L 332, 30.12.1995, p. 15. 

<± 

European Parliament and Council Directive 

amending Council Directive 95/69/EC 

laying down the conditions and arrangements for approving 

and registering certain establishments and intermediaries 

operating in the animal feed sector 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN 
UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 

100a thereof, 

Having regard to the proposal from the Commission . 

Having regard to the opinion of the Economic and Social Committee , 

2 

Acting in accordance with the procedure laid down in Article 189b of the Treaty , 

• 

• 

' 

3 

Whereas Council Directive 95/69/EC of 22 December  1995 lays down the conditions and 

arrangements  for  approving  and  registering  certain  establishments  and  intermediaries 

operating  in  the  animal  feed  sector  and  amends  Directives  70/524/EEC,  74/63/EEC, 
79/373/EEC and 82/471/EEC4, 

OJNoL  332, 30.12.1995, p. 15. 

Whereas European Parliament and Council Directive ../../EC  extends the scope of Council 

Directive  93/74/EEC  of  13 September  1993  on  feedingstuffs 

intended  for  particular 

nutritional  purposes6  to  cover  nutritional  supplements  for  animals;  whereas  nutritional 

supplements  for  animals  are  similar  in  composition  to  premixtures  of  additives;  whereas 

establishments  manufacturing  nutritional  supplements  for  animals and their  intermediaries 

should  therefore  be  subject  to  the  rules  laid  down  in  Directive  95/69/EC  for  approving 

establishments  manufacturing  premixtures  of  additives  and  for  intermediaries  involved  at 

an  intermediate  stage  between  production  and  use  by  livestock  farmers  in  order  to 

guarantee  that  these  products  are  safe  to  use  and  to  prevent  harmful  effects  on  human  or 

animal  health  or  the  environment;  whereas  users  of  nutritional  supplements, for  animals 

should  also  be  registered  to  ensure  that  they  possess  thé  necessary  facilities  for  making 

appropriate use of the products in question; 

Whereas  Council  Directive  96/51 /EC  of  23 July  1996  has  amended  Council  Directive 

70/524/EEC  concerning  additives  in  feedingstuffs 

to  take  account  of  the  amendments 

indicated  in Article  17 of Directive 95/69/EC; whereas that Article is now superfluous  and 

should be deleted; 

Whereas  the  scope of  this Directive  is restricted  to  laying  down  the  rules  which  Member 

States  must  follow  when  approving  or  registering  establishments  and  intermediaries 

manufacturing  nutritional supplements for animals; 

Whereas  it  is  necessary  to  adopt  these  measures  at  Community  level  in  order  better  to 

achieve the objectives of guaranteeing the quality and safety of  feedingstuffs, 

OJ No L 237, 22.9.1993, p. 23. 
OJNoL235,  17.9.1996, p. 39. 

HAVE ADOPTED THIS DIRECTIVE: 

Article 1 

Directive 95/69/EC is hereby amended as follows: 

1.  Article l(3)(b) and (c) are replaced by the following: 

"(b) 

"establishment1  means  any  unit  producing  or  manufacturing  additives, 

premixtures  prepared from additives, nutritional  supplements  for  animals* 

compound feedingstuffs  or products covered by Directive 82/471/EEC and 

referred to in Chapter 1.1(a) of the Annex to this Directive; 

(c) 

'intermediary' means any person other than the manufacturer  or the person 

producing  compound  feedingstuffs  for  the  exclusive  requirements  of  his 

holding  who  holds  additives,  premixtures  prepared  from  additives  or 

nutritional  supplements  for  animals,  or  one  of  the  products  covered  by 

Directive 82/471/EEC and referred to inChapter 1.1(a) of the Annex to this 

Directive at an intermediate stage between production and use." 

2.  In Article 2: 

(i) 

The following is added to paragraph 2: 

"(g)  manufacturing  nutritional  supplements  for  animals  as  referred  to  in 

Directive ../.../EC, with a view to putting them into circulation, must meet 

the minimum conditions laid down in Chapter 1.2 (b) of the Annex." 

(ii) 

The following paragraph is added: 

"4. Approved establishments engaged in the corresponding activities referred to 

in  paragraph 2(b)  shall  automatically  be  deemed  to  meet  the  conditions 

referred to in paragraph 2(g)." 

3.  Article 3(1) is replaced by the following: 

"Article 3 

Approval of intermediaries 

1.  Where  additives, products  covered by Directive  82/471/EEC, premixtures of 

additives or nutritional  supplements for animals referred  to in Chapters 1.1(a) 

and  1.2(a) of the Annex  respectively  are put into  circulation,  intermediaries 

must be approved. 

The provisions laid down in point 7 of Chapter 1.1(b) or Chapter 1.2(b) of the 

Annex shall apply, as appropriate, to intermediaries which wrap, package, store 

or  put  into  circulation  additives,  premixtures  of  additives,  nutritional 

supplements for animals or products covered by Directive 82/471/EEC. " 

4. 

Article 6(2) is replaced by the following: 

"2.  Before 31 December each year, Member States shall send the Commission the 

list referred to in paragraph 1. 

Before  31 December  each year, Member States shall send the other Member 

States a list of the establishments referred to in Article 2(2)(a), (b) and (g) and 

of the intermediaries approved in accordance with Article 3(1). 

Upon request, Member States shall send the other Member States all or part of 

the list of establishments referred to in Article 2(2)(c) to (f)." 

5. 

The following  is added to Article 7(2): 

"(e)  using,  for  the  exclusive  requirements  of  its  holding,  nutritional  supplements 

for animals referred to in Chapter 1.2(a) of the Annex must meet the minimum 

conditions laid down in Chapter 11(c) of the Annex." 

6. 

Article  14 is replaced by the following: 

"Article 14 

Fees 

The Council, acting by a qualified majority  on a proposal from the Commission, shall: 

before  1  April  1998, adopt the amounts of the fees to be charged for the approval of 

establishments as referred to in Article 2(2)(a) to (f) and their intermediaries and 

before  1  October  1999, adopt the amounts of the fees to be charged for the approval 

of establishments as referred to in Article 2(2)(g) and their intermediaries." 

7. 

The first subparagraph of Article 15(a) is replaced by the following: 

"(a)  - 

before  1 April  1998, practical  arrangements  for  the  approval  pursuant  to 

Article 2(2)(a) to (f)  and registration pursuant -to Article  7(2)(a) to  (d) of 

establishments  located  in  a  non-member  country  and  putting  additives, 

premixtures, products  covered  by Directive  82/471 /EEC  as referred  to in 

Chapter  1.1(a)  of  the  Annex  to  this  Directive  or  feedingstuffs 

into 

circulation within the Community, and, 

before  1 October  1999, practical  arrangements  for  the  approval  pursuant 

to Article 2(2)(g) of establishments  located in a non-member  country  and 

putting  nutritional  supplements  for  animals  into  circulation  within  the 

Community. 

so that safeguards  are provided equivalent to those supplied by  establishments 

located in the Community. 

8. Article" 16 is replaced by the following: 

"Article 16 

Standing  Committee  for  Feedingstuffs 

1. 

Where  the  procedure 
Commission  shall  be  assisted 

laid  down  in  this  Article 

is  to  be  followed, 

in  an  advisory  capacity  by 

the 
the  Standing 

Committee  for  Feedingstuffs,  set  up  by  Council  Decision  70/372/EEC, 

hereinafter  referred  to as  "the Committee". 

2. 

The  Chairman  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  set  according  to  the  urgency  of  the  matter,  where 

necessary  taking  a vote. 

3. 

The  opinion  shall  be  entered  in  the  minutes;  in  addition,  each  Member  State 

shall  have  the  right  to request  that  its position be entered  in the  minutes. 

4. 

The  Commission  shall  take  the  fullest  account  of  all  aspects  of  the  opinion 

delivered  by  the  Committee.  It  shall  inform  the  Committee  of  the  way  in  which 

"  it has  taken account of  its opinion. " 

9. 

Article  17 is deleted. 

10. 

Articles  18,  19, 20,  21, 22  and  23  become  Articles  17,  18,  19, 20,  21  and  22 

respectively. 

11. 

The Annex to the Directive is amended as follows: 

11.1.  Chapters  1.2(a) and 1.2(b) of the  Annex to the Directive  are replaced  by the 

following: 

"CHAPTER I.2.(a) 

Additives referred to in Article 2(2)(b) and Article 3(1) 

Antibiotics: 

all additives in the group 

Coccidiostats and other 

medicinal substances: 

all additives in the group 

Growth promoters: 

all additives in the group 

Vitamins, provitamins 

and chemically  well-defined 

substances having a similar 

effect: 

Trace elements: 

AandD 

Cu and Se 

Nutritional  supplements 

for animals: 

all  nutritional 

supplements 

for 

animals  referred 

to 

in  Directive 

93/74/EC  as  amended  by  Directive 

../.../EC. 

CHAPTER  I.2.(b) 

Minimum  conditions  which  must  be  fulfilled  by  establishments 

referred 

to 

in 

Article 2(2)(b)  and  (g)  and  intermediaries  referred  to  in  Article 3(1)  [premixtures  of 

additives and nutritional supplements for animals referred  to in Chapter 1.2(a)] 

1. 

Facilities and equipment 

Facilities and manufacturing  equipment must be located, designed, constructed  and 

maintained to suit the manufacture  of the premixtures or nutritional  supplements  for 

animals concerned. The layout, 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  operations  which  are  essential  for  the  quality  of  the  products  must  undergo 

appropriate  and  regular  checks  in  accordance  with  the  written  procedures 

established  in advance by the  manufacturer. 

Preventive  measures  must  be  taken  to  avoid,  as  far  as  possible,  the  presence  of 

harmful  organisms, with the introduction of a control plan if necessary. 

Personnel 

The manufacturer  must have sufficient  staff possessing the skills and  qualifications 

necessary  for  the  manufacture  of  the  premixtures  or  nutritional  supplements  for 

animals concerned. An organisational  chart setting out the qualifications  (diplomas, 

professional  experience) and responsibilities of the supervisory staff must be drawn 

up  and  made  available  to the  competent  authorities  responsible  for  inspection.  All 

the  staff  must  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 

quality of the premixtures or nutritional supplements for animals concerned. 

3. 

Production 

A qualified  person responsible for production must be designated. 

The manufacturer  must ensure that the different  stages in production  are carried out 

according  to pre-established  written procedures and  instructions  aimed  at  defining, 

checking  and  mastering  the  critical  points  in  the  manufacturing  process,  such  as 

incorporation  of  the  additive  in  the  premixture  or  mixing  of  the  different 

components  oï  the  nutritional  supplement  for  animals,  chronological  order  of 

production,  meters and  weighing  apparatus, mixer and returns, in such  a way  as to 

obtain  the  desired  quality  of the premixtures  or nutritional  supplements  for  animals 

concerned  in accordance with Directive 70/524/EEC or Directive .../.../EC. 

Technical  or  organisational  measures  must  be  taken  to  avoid  cross-contamination 

a lid errors. 

10 

4. 

Quality control 

A qualified person responsible for quanty control must be designated. 

The manufacturer  must have access to a quality control laboratory having  adequate 

staff  and  equipment  to  guarantee  and  check  that  the  premixtures  or  nutritional 

supplements  for  animals  concerned  comply  with the  specifications  defined  by  the 

manufacturer  and which will guarantee and check, in particular, the nature, content, 

homogeneity  and  stability  of the additives  in the premixture  or the components  of 

the nutritional supplement for animals, and as low a level of cross-contamination  as 

possible. The use of an outside laboratory is permitted. 

A quality control plan must be drawn up in writing and implemented, to include, in 

particular,  checks  on  the  critical  points  in  the  manufacturing  process,  sampling 

procedures  and  frequencies,  methods  of  analysis  and  their  frequency,  compliance 

with the specifications  - and destination in the event of non-compliance - for carrier 

substances,  additives,  premixtures  and  the  components  and  the  nutritional 

supplement for animals itself ('products'). 

Samples of each batch of premixture or nutritional  supplement  for  animals put into 

circulation  must  be  taken  in  sufficient  quantity  by  a  procedure  established  in 

advance by the manufacturer  and be retained  in order to ensure traceability.  These 

samples  must be sealed  and  labelled  for  ease of identification;  they must  be  stored 

under  conditions  which  prevent  any  abnormal  change  in  the  composition  of  the 

sample  or  any  abnormal  adulteration.  They  must  be  kept  at  the  disposal  of  the 

"competent  authorities  at  least  until  the  guarantee  date  of  the  premixture  or 

nutritional supplement for animals. 

11 

Storage 

'Products' which meet the specifications  - and those which do not - must be stored in 

suitable containers or in places designed, adapted and maintained  in order to ensure 

good storage conditions, to which only persons authorized by the manufacturer  have 

access. 

Preventive  measures  must  be  taken  to  avoid,  as  far  as  possible,  the  presence  of 

harmful  organisms, with the introduction of a control plan if necessary. 

The 'products' must be stored in such a way as to be easily identifiable  and to avoid 

any  confusion  or  cross-contamination  between  the  different  products  and  with 

medicinal  substances. Premixtures and nutritional  supplements for animals must be 

wrapped  and  labelled  in  accordance  with  Directive  70/524/EEC  or  Directive 

../.../EC, as appropriate. 

Documentation 

6.1.  Documentation relating to the manufacturing process and controls 

The  manufacturer  must  have  a  system  of documentation  designed  to  define 

and ensure the mastery of the critical points in the manufacturing process, and 

to  establish  and  implement  a  quality  control  plan.  The  manufacturer  must 

keep the results of the relevant controls. This set of documents must  be kept 

in such a way as to make it possible to trace the manufacturing  history of each 

batch of premixture or nutritional  supplement for animals put into circulation 

and to establish responsibility if complaints arise. 

12 

6.2.  Register of premixtures and nutritional supplements for animals 

The manufacturer  must record the following  information  in order to ensure 

traceability: 

-  the  names  and  addresses  of  manufacturers  of  additives  and  products 

covered by Directive 82/471/EEC and referred  to in Chapter 1.1(a) or of 

intermediaries, the nature and quantity of the additives or products covered 

by Directive 82/471/EEC and referred to in Chapter 1.1(a) used and, where 

appropriate,  the  number  of  the  batch  or  of  the  specific  portion  of 

production in the case of continuous manufacture, 

-  the  date of manufacture  of the premixture  or nutritional  supplement  for 

animals, the batch number where appropriate, 

4. 

* 

'. 

-  the  names  and  addresses  of  the  intermediaries  or  manufacturers  of 

compound  feedingstuffs  to  whom the premixture  is  delivered  or  of  the 

livestock  farmers  in the case of nutritional  supplements  for  animals, the 

delivery  date,  the  nature  and  quantity  of  the  premixture  or  nutritional 

supplement  for  animals  delivered,  and  the  batch  number  where 

appropriate. 

Intermediaries referred to in Article 3 (1) 

Where the manufacturer delivers premixtures or nutritional supplements for animals 

to  a person  other  than  a  manufacturer  of  compound  feedingstuffs  or  a  livestock 

farmer,  that person and any subsequent intermediary  by whom they  are wrapped, 

packaged, stored or put into circulation shall be equally bound, as appropriate, by 

the obligations laid down in points 4, 5, 6.2 and 8 and, in the case of wrapping, by 

those laid down in point 3. 

13 

8. 

Complaints and product recall 

The manufacturer  or any  intermediary  putting  a product  into  circulation  under  his 

own name must implement a system for registering and processing complaints. 

Likewise,  he  must  be  in  a  position» to  introduce,  where  this  proves  necessary,  a 

system for  prompt recall of products in the distribution network.  The  manufacturer 

must define by means of written procedures the destination of any recalled products, 

and  before  such  products  are  put  back  into  circulation  they  must  undergo  a 

quality-control  reassessment. 

11.2. 

In Chapter II: 

11.2.1.  The following is inserted after Chapter 11(b) : 

"CHAPTER II(b)a 

Nutritional supplements for animals: 

All  the  nutritional  supplements  for  animals  referred  to  in  Directive 

93/74/EEC as amended by Directive ../.../EC." 

14 

11.2.2. 

In Chapter 11(c): 

11.2.2.1.  The 

introductory 

sentence  and  point  1  "Facilities  and 

equipment" are replaced by the following: 

"CHAPTER 11(c) 

Minimum conditions which must be fulfilled  by  establishments 

and  intermediaries  referred  to  in  Article 7(2)(a)  and  (b)  and 

Article 8(1), [additives for which a prescribed maximum level is 

set and which are not referred  to in Chapter 1.1(a)], premixtures 

of additives referred  to in Chapter 11(a), establishments  referred 

to in Article 7(2)(c) and (d) [compound feedingstuffs  containing 

premixtures of additives referred  to in Chapter 11(b) or additives 

referred  to  in  Chapter  11(a)] and  establishments  referred  to  in 

Article 7(2)(e) (users of nutritional supplements for animals). 

1.  Facilities and equipment 

Facilities and technical equipment must be located, designed, 

constructed  and  maintained  to  suit  the  manufacture  of  the 

additives, premixtures  of additives,  compound  feedingstuffs 

containing  additives  or  premixtures  of  additives  or 

nutritional  supplements  for  animals  concerned  ('products 

concerned'). 

Establishments  using  nutritional  supplements  for  animals 

must  have  the  appropriate  equipment  for  dosing  and 

distributing the products; where a nutritional  supplement  for 

animals  is  distributed  in  drinking  water,  the  establishment 

must have a separate water circuit for the purpose." 

15 

11.2.2.2. Point 5 is replaced by the following: 

"5. 

Storage 

Raw materials, additives, carrier substances, premixtures, nutritional 

supplements for animals and compound feedingstuffs  must be stored 

in places designed, adapted  and maintained  in order to ensure  good 

< storage conditions. 

The  products  must  be  stored  in  such  a  way  as  .to  be  easily 

identifiable  and  to  avoid  any  confusion  or  cross-contamination 

between the different  products mentioned above and with  medicinal 

substances  or  medicinal  feedingstuffs.  Products  to  be  put  into 

circulation  must  be  wrapped,  where  appropriate,  and  labelled  in 

accordance  with  the  provisions  of  Directive  70/524/EEC  or 

Directive 79/373/EEC, as appropriate." 

11.2.2.3. The following  is added to point 6: 

"(d)  for  compound  feedingstuffs  containing  nutritional  supplements  for 

animals: 

the  names  and  addresses  of  the  manufacturers  of  the 

nutritional  supplements  for  animals  or  intermediaries,  with 

the  batch  number  where  appropriate,  and  the  nature  and 

quantity of the nutritional supplement for animals used; 

the  nature  and  quantity  of  the  feedingstuffs  manufactured, 

with the date of manufacture. 

16 

Article 2 

1. 

Member  States  shall  bring  into  force  the  laws,  regulations  and  administrative 

provisions needed to comply with this Directive  by  1  October  1999 at the latest. 

They shall immediately inform the Commission thereof. 

The  provisions  adopted  by  the  Member  States  shall  contain  a  reference  to  this 

Directive  or  shall be accompanied  by such reference  at the tipe  of their  official 

publication.  The  procedure  for  such  reference  shall  be  adopted  by  the  Member 

States. 

2. 

Member States shall forward to the Commission the text of the main provisions of 

domestic law which they adopt in the subject area governed by this Directive. 

Article 3 

This Directive shall enter into force on the 20th day following its publication in the Official 

Journal of the European Communities. 

This Directive is addressed to the Member States. 

Article 4 

Done at Brussels, 

For the European Parliament 

The President 

For the Council 

The President 

17 

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