Proposal for a Regulation of the European Parliament and of the Council laying down requirements for feed hygiene
Date: 2003-04-15
Institutions: European Commission
Subjects: animal nutrition, food additive, food industry, food safety, health control, product quality, traceability

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 14.04.2003
COM(2003) 180 final

2003/0071 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down requirements for feed hygiene

(presented by the Commission)

EXPLANATORY MEMORANDUM

I.

Current situation

The main purpose of the current Directive 95/69/EC of 22 December 1995 laying down the
conditions  and  arrangements  for  approving  and  registering  certain  establishments  and
intermediaries  operating  in  the  animal  feed  sector  (as  last  amended  by  Council  Directive
1999/29/EC of 22 April 1999) is to ensure that certain establishments and intermediaries that
manufacture,  produce  or  put  into  circulation  certain  additives,  premixtures,  compound
feedingstuffs  and  products  covered  by  Directive  82/471/EEC  are  approved  or  registered  by
competent  authorities  verifying  compliance  with  the  technical  specifications  detailed  in  the
annexes.

Commission Directive 98/51/EC of 9 July 1998 lays down certain measures for implementing
Council Directive 95/69/EC.

The  production  or  use  of  some  of  the  products  requires  only  registration,  based  on  an
undertaking by the establishment to comply with a number of conditions.

The production or use of some other products requires approval of the plant on the basis of
very  strict  conditions  designed  to  safeguard  animals,  humans  and  the  environment.  Such
approval is subject to a mandatory on-the-spot verification by the competent authority that the
conditions laid down in the Directive have been complied with.

According to the current legislation, the different level of risk to human health, animal health
and  the  environment  justifies  this  dual  regime  for  the  production  and  use  of  the  different
substances. Approval applies to establishments which intend to manufacture or use products
deemed  sensitive,  whilst  mere  registration  applies  to  establishments  using  less  sensitive
products.

Upon  completion  of  the  procedure,  applicants  are  issued  with  an  approval  number  or  a
registration number, as the case may be, and the firms concerned are entered in lists drawn up
by the competent authority.

Feed  businesses  operating  in  the  feed  chain  and  carrying  out  activities  other  than  those
described in Directive 95/69/EC are exempt from the registration or approval requirement.

The  Directive  has  been  in  force  since  8  February  1996,  and  Member  States  should  have
adopted,  not  later  than  1  April  1998  the  laws,  regulations  and  administrative  provisions
necessary to comply with it.

2

II. The need for changes

Following  the  BSE  crisis,  the  two  occurrences  of  serious  dioxin  contamination  and  other
concerns  such  as  the  contamination  of  feed  materials  and  feedingstuffs  with  nitrofen  or
hormones, a need has been identified for an appropriate legal instrument to:

–  ensure safety of all kinds of feed;

–  ensure  that  all  feed  businesses  operate  in  accordance  with  harmonised  hygiene

requirements; and

–  improve traceability

III. Feed Hygiene

The  implementation  of  Directive  95/69/EC  has  shown  that  some  of  the  conditions  remain
valid and that their application could be extended to the production of all kinds of feed.

It  therefore  makes  sense  at  the  present  time  to  lay  down  requirements  for  feed  businesses
which  at  present  fall  outside  of  the  scope  of  Directive  95/69/EC  and,  at  the  same  time,  to
revise  the  minimum  conditions  in  order  to  make  general  and  clearer  rules  applicable  to  all
feed  businesses,  provide  greater  transparency  and  take  into  account  recent  developments  in
feed hygiene:

a)

The HACCP system

(HACCP)  principles  prescribed  by 

In order to bring animal nutrition legislation into line with the principles of food hygiene laid
down by the Codex Alimentarius, it is proposed that the Hazard Analysis and Critical Control
Points 
introduced.  The
implementation  of  these  principles  will  be  mandatory  for  all  feed  business  operators  other
than  at  the  level  of  primary  production.  It  prescribes  a  number  of  steps  to  be  followed  by
operators throughout the production cycle in order to facilitate - through hazard analysis - the
identification of points where control is critical with regard to feed safety.

that  organization  be 

In  implementing  HACCP,  operators  will  have  to  live  up  to  their  responsibilities.  They  will
need to design a specific monitoring programme. All potential hazards must be identified and
proper  control  procedures  for  each  feed  business  individually  established.  Corrective  action
must be taken when controls show that problems may occur. Regular updates of the  system
must be made.

The principles contain the obligation to keep documents and records of whatever checks are
carried out. This allows for more efficient and effective control by the competent authorities.

3

b)

Traceability

Traceability is already a general requirement laid down  in Regulation (EC) No 178/2002 of
the  European  Parliament  and  of  the  Council  of  28  January  2002  laying  down  the  general
principles and requirements of food law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety.

Experience has clearly shown animal feed to be the cause of some incidents that could pose a
risk to human and animal health.

Successive  feed  crises  have  demonstrated  that  identifying  the  origin  of  feed  is  of  prime
importance in terms of health protection. In particular, traceability facilitates the withdrawal
of  feed  and  food  and  enables  the  competent  authorities  to  be  provided  with  targeted  and
accurate information on whatever products are involved.

The  new  proposal  introduces  the  compulsory  registration  of  all  feed  businesses  by  the
competent  authority.  In  certain  cases,  where  it  is  necessary  to  have  certainty  about  whether
feed businesses are complying with the hygiene rules, approval will be required. In such cases
the competent authority will give official approval following an on-the-spot visit to check on
compliance.

c)

Responsibilities and hygiene

Under  European  food  law,  and  more  especially  in  hygiene  legislation,  the  primary
responsibility  for  ensuring  compliance  with  food  law,  and  in  particular  the  safety  of  food,
rests with food businesses. This proposal will extend the principle to the entire feed chain.

This  proposal  seeks  to  ensure  that  feed  safety  is  considered  at  all  stages  that  may  have  an
impact on feed and food safety. A feed business must therefore ensure that feed for which it is
responsible  does  not  have  the  potential  to  cause  a  feed  or  food  safety  problem,  and  should
ensure  that  working  practices  are  such  that  feed  and  food  safety  is  not  compromised.  The
proposal establishes a requirement that only safe feed be placed on the market and establishes
a link with the need to ensure that food from animals fed on such feed is safe.

Conditions  for  feed  business  operators  may  differ  according  to  whether  they  are  or  are  not
operating at the level of primary production.

For  instance,  the  duration  of  the  production  cycle  at  primary  level  can  predispose  to
unavoidable  events  that  may  occur,  such  as  weather-related  or  environmental  factors.  It  is
difficult then to develop the awareness needed to identify all possible risks and to establish an
appropriate control programme to deal with them.

Then again, unacceptable risks may occur on manufacturing premises, for example, as a result
of  wrong  practices  at  any  stage  of  the  preparation,  processing,  manufacturing,  packaging,
storing,  transportation,  distribution  and  handling  of  feed.  The  idea  is  to  improve  preventive
measures  by  establishing  appropriate  control  systems,  with  the  various  processing  stages
being analysed to establish the relevant risk. The feed chain is very complex, and the multi-
ingredient composition of feed is often also complicated, so failures at any stage in the chain

4

can  have  huge  consequences.  Feed  business  operators  must  ensure  then,  by  providing  a
financial guarantee, that they are covered for risks related to their business, more especially,
costs arising from the withdrawal from the market, treatment and/or destruction of feed, and
food produced therefrom, that can present a serious risk to human or animal health and/or the
environment.

d)

Imports of feed from non-member countries

Provisions are made  for  feed  imported into the Community to  comply  with  the  Community
hygiene  standards  or  with  equivalent  standards  in  Commission’s  proposal  for  a  Regulation
(EC) …/… on official feed and food controls.

More particularly:

- the third country of dispatch must appear on a list of third countries from which imports of
feed are permitted;

- the establishment of dispatch must appear on a list of establishments from which imports of
feed are permitted;

e)

The farm to table approach and primary production

It is essential to be consistent with the cornerstone of the food and feed safety policy, i.e. the
"farm  to  table"  approach,  and  to  include  the  primary  production  stage  under  conditions  of
registration and feed hygiene. Hazards in feed may originate at the farm, which is  why  it is
proposed that the hygiene rules be extended to cover hygiene at farm level. This will provide
Community  legislation  with  an  instrument  that  covers  the  entire  feed  chain  and  the  food
chain,  from  farm  to  table.  To  achieve  the  required  level  of  hygiene  at  farm  level,  it  is
suggested that possible hazards occurring in primary production and methods to control such
hazards be addressed in guides to good practice.

To  exempt  farms  producing  feed,  and  to  exclude  animal  feeding,  would  give  rise  to  a
divergence in the approach to food legislation, a degree  of inconsistency  and  some lacunae,
which would be difficult to justify.

f)

Flexibility

Experience in the Community has shown that a certain flexibility is needed, in particular for
small  businesses,  especially  those  situated  in  regions  suffering  from  special  geographical
constraints.

The proposal aims to provide for such flexibility by requiring Member States, as a matter of
subsidiarity,  to  ensure  the  appropriate  level  of  hygiene  in  these  businesses,  without
compromising the objectives of feed safety. The competent authorities in the Member States
are the most appropriate bodies to judge about the needs at that level, and they must take their
responsibility in this issue.

5

The own-checking system has to be made sufficiently flexible to take account of the different
circumstances which may be present in practice, in particular with regard to small businesses.
For that purpose, guides of practices can be developed to help implement the HACCP system.

IV. Feed hygiene and the Commission's White Paper on food safety

The  proposal  takes  into  account  the  principles  of  food  safety  that  are  spelt  out  in  the
Commission's White Paper on food safety1, in particular that:

– 

– 

– 

– 

– 

The  farm  to  table  policy,  covering  all  sectors  of  the  feed  chain  (including
primary  production,  animal  feeding  and  feed  production),  needs  to  be
systematically implemented.

Feed safety policy must be based on a comprehensive and integrated approach.

Feed businesses, manufacturers and farmers have the primary responsibility for
feed and food safety, with the competent authorities taking on a monitoring and
enforcement role.

A successful food policy depends on the traceability of feed and food and their
ingredients.

Feed safety policy must be risk-based.

This proposal also takes into account some of the provisions laid down in Regulation (EC) No
178/2002, such as:

– 

– 

– 

– 

– 

– 

– 

To  provide  a  high  level  of  animal  and  human  health  and  also  for  the
environment;

To ensure effective functioning of the internal market in safe feed;

To ensure feed traceability;

To make feed business operators primarily responsible for safe feed;

To make Member States responsible for the enforcement of food law;

To ensure that only safe feed is placed on the market;

To make feed business operators responsible where their products or activities
may have an adverse impact on feed safety.

In  conclusion,  it  is  proposed  in  this  Regulation  that  some  general  feed  safety  conditions  be
extended so as to cover hygiene at all levels in the feed chain.

1

COM (1999) 719 final, 12 January 2000

6

                                                
V. Summary

This proposal for a European Regulation responds to all these commitments by laying down
requirements  for  a  comprehensive  system  of  registration  of  all  feed  business  operators  and
requirements for feed production.

This Regulation will also lay down responsibilities and obligations for feed businesses which
will  address  the  causes  of  feed  safety  problems  in  a  broad  manner  and  will  include
requirements for feed businesses at the level of primary production.

General principles and definitions relating to feed production, including the responsibilities of
feed  business  operators  on  the  one  hand  and  of  the  Member  States'  authorities  on  the  other
hand, are already laid down in Regulation (EC) 178/2002 and in the Commission’s proposal
for a Regulation (EC) …/…on feed and food controls.

VI. The Form of the Acts

As explained in the Commission’s Green Paper on the general principles of food law in the
European  Union,  the  Commission  believes  that  enacting  Community  law  in  the  form  of
regulations  presents  a  number  of  advantages,  such  as  guaranteeing  uniform  application
throughout the single market, making Community law more transparent and enabling it to be
updated  quickly  to  take  account  of  technical  and  scientific  developments.  It  is  for  these
reasons that the present proposal is submitted in the form of a Regulation.

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2003/0071 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

laying down requirements for feed hygiene

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article
37(2) and Article 152 (4)(b) thereof,

Having regard to the proposal from the Commission2,

Having regard to the opinion of the European Economic and Social Committee3,

Having regard to the opinion of the Committee of the Regions4,

Acting in accordance with the procedure laid down in Article 251 of the Treaty5,

Whereas:

(1) 

(2) 

Livestock  production  plays  a  very  important  part  in  the  agricultural  sector  of  the
Community. Satisfactory results depend to a large extent on the use of safe and good
quality feed.

The pursuit of a high level of protection of human health and animal health is one of
the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002
of  the  European  Parliament  and  the  Council  of  28  January  2002  laying  down  the
general  principals  and  requirements  of  food  law,  establishing  the  European  Food
Safety  Authority  and  laying  down  procedures  in  matters  of  food  safety6.  That
Regulation  also  lays  down  other  common  principles  and  definitions  for  national  and
Community  food  law,  including  the  aim  of  achieving  free  movement  of  feed  within
the Community.

(3) 

Council  Directive  95/69/EC  of  22  December  1995  laying  down  the  conditions  and
arrangements for  approving and registering certain  establishments  and  intermediaries
operating in the animal feed sector and amending Directives 70/542/EEC, 74/63/EEC,
79/373/EEC and 82/471/EEC7 established the conditions and arrangements applicable

2

3

4

5

6

7

OJ C , , p. .
OJ C , , p. .
OJ C , , p. .
OJ C , , p. .
OJ L 31, 1.2.2002, p. 1.
OJ L 332, 30.12.1995, p. 15. Directive as last amended by Directive 1999/29/EC (OJ L 115, 4.5.1999,
p. 32).

8

                                                
(4) 

(5) 

(6) 

(7) 

(8) 

to certain categories of establishments and intermediaries in the animal feed sector to
enable  them  to  exercise  their  activities.  Experience  has  shown  that  these  conditions
and arrangements constitute a sound basis for ensuring feed safety

Commission  Directive  98/51/EC  of  9  July  1998  laying  down  certain  measures  for
the  conditions  and
implementing  Council  Directive  95/69/EC 
arrangements for  approving and registering certain  establishments  and  intermediaries
operating  in  the  animal  feed  sector8  established  certain  measures  for  implementing
Council  Directive  95/69/EC,  including  arrangements  for  imports  from  non-member
countries.

laying  down 

Council Directive 95/69/EC established conditions for the approval of establishments
producing certain substances listed in Council Directive 82/471/EEC9 of 30 June 1982
concerning certain products used in animal nutrition.

Directive  98/34/EC  of  the  European  Parliament  and  of  the  Council  of  22  June  1998
laying  down  a  procedure  for  the  provision  of  information  in  the  field  of  technical
standards and regulations10 established the rules by which Member States can approve
technical specifications.

Experience  has  also  shown  that  it  is  necessary  to  ensure  that  all  feed  businesses
operate in conformity with harmonised safety requirements and that it is necessary to
conduct  a  general  review  to  take  into  account  the  need  to  ensure  a  higher  level  of
protection of animal and human health, and of the environment.

The principal objective of the new hygiene rules set out in this Regulation is to ensure
a  high  level  of  consumer  protection  with  regard  to  feed  and  food  safety,  taking
particular account of the following principles:

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

that primary responsibility for feed safety rests with the feed business operator;

the need to ensure feed safety throughout the food chain, starting with primary
production of feed up to and including the feeding of food producing animals;

the  general  implementation  of  procedures  based  on  the  principles  of  hazard
analysis  and  critical  control  points  (HACCP)  which,  together  with  the
application of good hygiene practice, should reinforce feed business operators’
responsibility;

that  guides  to  good  practice  are  a  valuable  instrument  to  help  feed  business
operators  at  all  levels  of  the  feed  chain  comply  with  feed  hygiene  rules  and
with the application of HACCP principles;

the establishment of microbiological criteria based on scientific risk criteria;

the need to ensure that imported feed attains at least an equivalent standard as
feed produced in the Community.

8

9

10

OJ L 208, 24.7.1998, p. 43.
OJ  L  213,  21.7.1982,  p.  8.  Directive  as  last  amended  by  Council  Directive  1999/20/EC  (OJ  L  80,
25.3.1999, p. 20)
OJ L 204, 21.7.1998, p. 37. Directive as last amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p.
18)

9

                                                
(9) 

(10) 

(11) 

An integrated approach is necessary to ensure feed safety from and including primary
production up to and including the placing on the market or export of feed.

In accordance with the principles of proportionality and subsidiarity, it is appropriate
that Community rules do not apply to certain cases of private domestic production of
feed  and  feeding  of  certain  animals  nor  to  the  direct  supply  of  small  quantities  of
primary products at local level and the retailing of pet food.

It is necessary that feed hazards present at the level of primary production be identified
and adequately controlled to ensure that the objectives of this Regulation are met. The
fundamental principles of the rules in this Regulation should therefore apply to farms
which manufacture feed solely for the requirements of their own production, as well as
to farms which place feed on the market. But in the case of the direct supply of small
quantities  of  primary  products  at  local  level  by  the  producer  to  local  farms,  it  is
appropriate to ensure feed safety through rules and guidance.

(12)  The  application  of  HACCP  principles  to  primary  production  of  feed  is  not  yet
generally feasible. But guides to good practice should encourage the use of appropriate
hygiene requirements.

(13)  Feed  safety  depends  on  a  number  of  factors.  Legislation  should  lay  down  minimum
hygiene  requirements.  Official  controls  should  be  in  place  to  check  feed  business
operators’  compliance.  In  addition,  feed  business  operators  should  take  measures  or
adopt procedures to achieve a high level of feed safety.

(14)  HACCP  can  help  feed  business  operators  attain  a  higher  standard  of  feed  safety.
HACCP  should  not  be  regarded  as  a  method  of  self-regulation  and  does  not  replace
official controls.

(15)  The  implementation  of  the  HACCP  principles  requires  the  full  co-operation  and

commitment of feed businesses’ employees.

(16)  HACCP  in  feed  production  should  take  into  account  the  principles  contained  in  the
Codex Alimentarius, but should allow sufficient flexibility in all situations. In certain
feed business, it is not possible to identify critical control points and,  in  some cases,
good  practices  can  replace  the  monitoring  of  critical  control  points.  Similarly,  the
requirement to establish “critical limits” does not require a numerical limit to be fixed
in every case. The requirement to retain documents needs to be flexible to avoid undue
burdens for very small businesses.

(17)  Flexibility is also necessary to accommodate the needs of feed businesses situated in
regions  suffering  from  special  geographical  constraints  or  in  respect  of  structural
requirements. But such flexibility should not compromise feed hygiene objectives. In
addition, since all feed produced in accordance with the hygiene rules is to be in free
circulation  throughout  the  Community,  the  procedure  allowing  Member  States  to
exercise  flexibility  should  be  fully  transparent.  Provision  should  be  made  for
discussion  within  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health
where necessary to resolve disagreements.

(18)  The registration of establishments and the co-operation of feed business operators are
necessary if the competent authorities are to carry out official controls efficiently.

10

(19) 

It  is  appropriate  that  an  approval  system  for  feed  businesses  be  maintained  for
activities which can present a higher risk in the manufacture of feed. Provision should
be made for procedures to extend the current scope of the approval system as presently
provided for in Directive 95/69/EC

(20) 

In  order  to  be  approved,  feed  businesses  should  meet  several  conditions  concerning
the  facilities,  equipment,  personnel,  production,  quality  control,  storage,  and
documentation to ensure both feed safety and product traceability.

(21)  Provision  should  be  made  for  temporarily  suspending,  amending,  withdrawing  or
renewing approval where establishments change or cease their activities or no longer
fulfil the conditions applicable to their activity;

(22)  A system of registration and approval by the competent authority of the Member State
of all feed businesses is appropriate to ensure traceability from manufacturer to final
user.

(23)  The traceability of feed and feed ingredients throughout the feed chain is an essential
element in ensuring feed safety. Regulation (EC) No 178/2002 contains rules to ensure
the traceability of feed and feed ingredients and provides a procedure for the adoption
of implementing rules applicable to specific sectors.

(24)  Successive feed crises have shown that failures at any stage in the feed chain can have
important economic consequences. Feed production and its complex distribution chain
does  not  make  it  the  withdrawal  of  feed  from  the  market  an  easy  task.  The  costs  of
rectifying  the  economic  damages  along  the  feed  and  food  chain  is  often  borne  by
public  funds.  The  remedying  of  this  economic  consequence  at  a  low  cost  to  society
could be improved if the operator, whose activity causes economic damage in the feed
sector, is held financially responsible. This gives operators an incentive to meet high
standards,  which  might  not  be  met  without  such  a  system  of  financial  liability.
Operators should provide an appropriate financial guarantee, such as an insurance, in
order to cover costs of the withdrawal of products from the market, treatment and/or
destruction of feed and food produced therefrom. This can induce  operators  to  adopt
measures and develop practices to minimise the risks related to their activities.

(25)  Feed imported into the Community must satisfy the general requirements laid down in
Regulation (EC) No 178/2002 and the import conditions laid down in Regulation (EC)
…/… on official feed and food controls11.

(26)  Community products exported to third countries must satisfy the general requirements

laid down in Regulation (EC) No 178/2002.

(27)  Scientific advice must underpin Community legislation on feed hygiene. To this end,
the European Food Safety Authority should be consulted whenever necessary.

(28)  To  take  account  of  technical  and  scientific  progress,  there  should  be  close  and
effective  co-operation  between  the  Commission  and  the  Member  States  within  the
Standing Committee on the Food Chain and Animal Health.

11

OJ L

11

                                                
(29)  This  Regulation  takes  account  of  international  obligations  laid  down  in  the  WTO
Sanitary  and  Phytosanitary  Agreement  and  the  international  food  safety  standards
contained in the Codex Alimentarius.

(30)  Directives 95/69/EC and 98/51/EC should be repealed;

(31) 

In  accordance  with  Directive  2002/32/EC  of  the  European  Parliament  and  of  the
Council  of  7  May  2002  on  undesirable  substances  in  animal  feed12,  feed  business
operators may not mix for dilution purposes feed containing levels of an undesirable
substance that exceed the maximum level.

(32)  The Member States should lay down rules on penalties applicable to infringements of
the  provisions  of  this  Regulation  and  ensure  that  they  are  implemented.  Those
penalties must be effective, proportionate and dissuasive.

(33)  The requirements of this Regulation should apply one year after its entry into force, to

allow the feed businesses affected by it time to adapt.

(34)  The measures necessary for the implementation of this Regulation should be adopted
in accordance with Council Decision 1999/468/EC of 28  June 1999  laying  down the
procedures for the exercise of implementing powers conferred on the Commission13,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1
Subject matter

This Regulation lays down:

(a)

(b)

1.

(a)

general rules on feed hygiene;

conditions and arrangements ensuring full traceability of feed.

Article 2
Scope

This Regulation shall apply to:

the  activities  of  feed  business  operators  at  all  stages,  from  and  including  primary
production up to and including the placing on the market of feed.

(b)

the feeding of food producing animals;

12

13

OJ L 140, 30.5.2002, p. 10
OJ L 184, 17.7.1999, p. 23

12

                                                
(c)

2.

(a)

(b)

(c)

(d)

imports from third countries.

This Regulation shall not apply to:

the  private  domestic  production  of  feed  for  food-producing  animals  for  private
domestic consumption and for animals not kept for food production;

the  feeding  of  food-producing  animals  for  private  domestic  consumption  and  of
animals not kept for food production;

the  direct  supply  of  small  quantities  of  primary  products  at  local  level  by  the
producer to local farms;

the retailing of petfood.

3.
Member States shall establish rules and guidance governing the activities referred to in
paragraph 2. Such national rules and guidance shall ensure the achievement of the objectives
of this Regulation.

Article 3
Definitions

For  the  purposes  of  this  Regulation,  the  definitions  in  Regulation  (EC)  No  178/2002  shall
apply subject to these specific definitions:

(a)

(b)

(c)

(d)

(e)

“feed hygiene”: means the measures and conditions necessary to control hazards and
to ensure fitness for animal consumption of a feed, taking into account its intended
use;

“feed business operator”: means the natural or legal person responsible for ensuring
that  the  requirements  of  the  present  Regulation  are  met  within  the  feed  business
under their control;

“feed additives”: means substances or micro-organisms authorised under Regulation
(…) on additives for use in animal nutrition;

“establishment”: means any unit of a feed business.

“competent  authority”:  means  the  authority  of  a  Member  State  or  a  third  country
designated to carry out official controls

CHAPTER II

OBLIGATIONS

Article 4

General obligations

Feed  business  operators  shall  ensure  that  all  stages  of  production,  processing  and
1.
distribution  under  their  control  are  carried  out  according  to  good  practice  as  referred  to  in

13

Chapter III of this Regulation and satisfy the relevant hygiene requirements laid down in this
Regulation.

2.

(a)

When feeding food-producing animals, livestock farmers shall:

take measures and adopt procedures to minimise the risk of biological, chemical and
physical contamination of feed, animals and animal products;

(b)

apply good animal feeding practice as referred to in Annex III.

Article 5

Specific obligations

Feed business operators at the level of primary production of feed shall comply with

1.
the provisions in Annex I, including the following associated operations:

(a)

(b)

the  transport,  storage  and  handling  of  primary  products  at  the  place  of  production,
provided that this does not substantially alter their nature;

transport  operations  to  deliver  primary  products,  the  nature  of  which  has  not  been
substantially altered, from the place of production to an establishment.

Feed  business  operators  other  than  at  the  level  of  primary  production  of  feed  as

2.
referred to in paragraph 1 shall comply with the provisions in Annex II.

3.

(a)

(b)

Feed business operators shall:

comply with specific microbiological criteria;

take measures or adopt procedures necessary to meet specific targets.

The criteria and targets referred to in points (a) and  (b) shall be adopted in accordance with
the procedure referred to in Article 31 (2).

Feed business operators may use the guides provided for in Articles 21 to 23 to help

4.
them comply with their obligations under this Regulation.

Livestock farmers shall comply with the provisions set out in Annex III when feeding

5.
food producing animals

Hazard analysis and critical control points (HACCP) system

Article 6

1.
Feed business operators other than at the level of primary production of feed shall put
in  place,  implement  and  maintain  a  permanent  procedure  or  procedures  based  on  the
principles of hazard analysis and critical control points (HACCP).

2.

(a)

The HACCP principles referred to in paragraph 1 are:

to identify any hazards that must be prevented, eliminated or reduced to acceptable
levels,

14

(b)

(c)

(d)

(e)

(f)

(g)

to identify the critical control points at the step or steps at which control is essential
to prevent or eliminate a hazard or reduce it to acceptable levels,

to establish critical limits at critical control points which separate acceptability from
unacceptability for the prevention, elimination or reduction of identified hazards,

to establish and implement effective monitoring procedures at critical control points,

to establish corrective action when monitoring indicates that a critical control point is
not under control,

to establish procedures to verify that  the  measures  outlined  in  subparagraphs  (a)  to
(e) are working effectively. Verification procedures shall be carried out regularly;

to  establish  documents  and  records  commensurate  with  the  nature  and  size  of  the
feed businesses to demonstrate the effective application of the measures outlined in
subparagraphs (a) to (f).

3.
When  any  modification  is  made  to  a  product,  process,  or  any  stage  of  production,
processing,  store  and  distribution,  feed  business  operators  shall  review  their  procedure  and
make the necessary changes.

4.
As part of the system of procedures referred to in paragraph 1, feed business operators
may use guides to good practice in conjunction with guides on the application of HACCP, as
developed in accordance with Article 21.

Measures to facilitate the  implementation of this Article,  including  small businesses,

5.
may be adopted in accordance with the procedure referred to in Article 31 (2).

Article 7
Documents concerning the HACCP system

Feed business operators shall:

provide the competent authority with evidence of their compliance with Article 6 in
the form requested by the competent authority;

ensure that any documents describing the procedures developed in  accordance  with
Article 6 are up-to-date at all times;

1.

(a)

(b)

The  competent  authority  shall  take  into  account  the  nature  and  size  of  the  feed

2.
business where fixing requirements as to the form referred to in paragraph 1(a).

3.
Detailed  arrangements  for  the  implementation  of  this  Article  may  be  laid  down  in
accordance  with  the  procedure  referred  to  in  Article  26.  Such  arrangements  may  facilitate
certain  feed  business  operators’  implementation  of  HACCP  principles  developed  in
accordance with Articles 21 to 23 with a view to complying with the requirements of Article 6
(1).

15

Article 8

Financial guarantees

Feed business operators shall ensure that a financial guarantee, such as insurance, is available
to cover the cost of risks related to their businesses. This guarantee shall provide cover for the
total  costs  of  the  withdrawal  from  the  market,  treatment  and/or  destruction  of  any  feed  and
food produced therefrom.

Article 9
Official controls, notification and registration

Feed business operators shall co-operate with the competent authorities in accordance

1.
with other applicable Community legislation or, where there is none, national law.

2.

The competent authority shall maintain a register of establishments

Feed business operators shall:

(a)

(b)

notify the appropriate competent authority of any establishments under their control
active in any of the stages of production, processing, store or distribution of feed in
the form required by the competent authority with a view to registration.

provide  the  competent  authority  with  up-to-date  information  on  any  establishments
under  their  control  as  referred  in  point  (a)  including  notifying  the  competent
authority  of  any  significant  change  in  activities  and  any  closure  of  an  existing
establishment.

Article 10
Approval of feed business establishments

Feed business  operators  shall  ensure  that  establishments  under  their  control  and  covered  by
this Regulation are approved by the competent authority, where:

(1)

(a)

(b)

(c)

(2)

(3)

such establishments carry out one of the following activities:

manufacturing and/or placing on the market of feed additives or products covered by
Directive 82/471/EEC and referred to in Chapter 1 of Annex IV to this Regulation;

manufacturing  and/or  placing  on  the  market  of  premixtures  prepared  from  feed
additives referred to in Chapter 2 of Annex IV to this Regulation;

manufacturing  (and/or  placing  on  the  market)  or  producing  for  the  exclusive
requirements of its holding, compound feedingstuffs containing premixtures prepared
from feed additives referred to in Chapter 3 of Annex IV to this Regulation;

approval  is  required  under  the  national  law  of  the  Member  State  where  the
establishment is located;

approval is required by a decision adopted in accordance with the procedure referred
to in Article 31 (2).

16

Feed business operators shall not operate without:

Article 11

(a)

(b)

registration as provided for in Article 9; or

approval, when required in accordance with Article 13.

Article 12
Member States to provide information on national rules on approval

Any Member State requiring the approval under national law of certain establishments located
on  its  territory  shall  inform  the  Commission  and  the  other  Member  States  of  the  relevant
national rules.

Article 13
Approval of establishments by the competent authority

The  competent  authority  shall  approve  establishments  only  where  an  on-site  visit  prior  to
start-up  of  any  activity  has  demonstrated  that  they  meet  the  relevant  requirements  of  this
Regulation.

Article 14
Suspension of registration or approval by the competent authority

The  competent  authority  shall  temporarily  suspend  the  registration  or  approval  of  an
establishment for one, more or all of the activities where it is shown that the establishment no
longer fulfils the conditions applicable to those activities.

Such suspension shall last until the establishment again meets those conditions. Where such
conditions are not met within one year, Article 15 shall apply.

Article 15
Revocation of registration or approval by the competent authority

The competent authority shall revoke the registration or approval of an establishment for one
or more of its activities where:

(a)

(b)

the establishment ceases one or more of its activities;

it  is  shown  that  the  establishment  has  not  fulfilled  the  conditions  applicable  to  its
activities for a period of one year.

17

Article 16
Amendments to registration or approval of an establishment

The competent authority shall amend the registration or approval of an establishment where
the establishment has demonstrated its ability to engage in activities which are additional to
those for which it was first approved or which replace them.

Article 17
Renewal of approvals

The approval of establishments shall be renewable every five years.

The  competent  authority  shall  renew  the  approval  of  establishments  only  where  an  on-site
visit has demonstrated that they meet the relevant requirements of this Regulation.

Article 18
Exemption from on-the-site visits

Member States are exempted from the obligation to carry out on-the-site visits as provided for
in  Articles  13  and  17  in  feed  businesses  which  act  solely  as  traders  without  holding  the
products on their premises.

Such feed business shall submit to the competent authority a declaration to the effect that the
feed placed on the market complies with the conditions of this Regulation.

Article 19
Transitional measures

1. 

2. 

Establishments  and  intermediaries  approved  and/or  registered  in  accordance  with
Directive  95/69/EC  may  continue  their  activities  until  one  year  from  the  day  of
application  of  this  Regulation,  on  condition  that  they  submit,  to  the  relevant
competent  authority  in  whose  area  their  facilities  are  located,  an  application  for
approval before the day of application of this Regulation.

In their application they must declare that the conditions laid down in this Regulation
have been met.

The competent authorities may request the applicant to provide only such additional
information which guarantees compliance with the conditions of this Regulation.

Establishments  and  intermediaries  requiring  neither  approval  nor  registration  in
accordance  with  Directive  95/69/EC  but  requiring  registration  in  accordance  with
this  Regulation  may  continue  their  activities  until  one  year  from  the  day  of
application  of  this  Regulation,  on  condition  that  they  submit,  to  the  relevant
competent  authority  in  whose  area  their  facilities  are  located,  an  application  for
registration before the day of application of this Regulation.

In their application they must declare that the conditions laid down in this Regulation
have been met.

18

Article 20

List of approved establishments

1.

2.

3.

4.

5.

For  each  activity,  the  competent  authority  shall  enter  the  establishments  it  has
approved  in  accordance  with  Article  13  in  a  national  list  under  an  individual
identifying number.

Member  States  shall  update  the  entries  of  establishments  in  the  list  referred  in
paragraph 1 in accordance with the decisions referred to in Articles 14, 15 and 16 to
suspend, withdraw or amend approval.

The list referred to in paragraph 1 must be drawn up in accordance with the model
set out in Annex V, Chapter I.

The approval number referred to in paragraph 1 shall be in the form set out in Annex
V, Chapter II.

Each  Member  State  shall  publish  the  list  of  the  establishments  approved  in
accordance with Article 13 for the first time in [November …], and thereafter each
year, by 30 November at the latest, the consolidated list of amendments made during
the year.

CHAPTER III

GUIDES TO GOOD PRACTICE

Article 21
Development, dissemination and use of guides

Member States shall encourage the development of national guides to good practice in

1.
the feed sector and for the application of HACCP principles in accordance with Article 22.

Community guides shall be developed in accordance with Article 23.

The  dissemination  and  use  of  both  national  and  Community  guides  shall  be

2.
encouraged by the competent authorities.

3.

Nevertheless, feed business operators may use these guides voluntarily.

Article22
National guides

1.

National  guides  to  good  practice  shall  be  developed  and  disseminated  by  feed
business sectors, in consultation with representatives of parties whose interests may
be substantially affected, including competent authorities, taking into account;

(a)

relevant codes of practice of the Codex Alimentarius; and

19

(b)

when they concern primary production, the requirements set out in Annex I.

National  guides  may  be  developed  under  the  aegis  of  a  national  standards  institute

2.
referred to in Annex II to Directive 98/34/EC.

3.

(a)

(b)

(c)

Member States shall assess national guides to ensure that:

they have been developed in accordance with paragraph 1;

the contents of such guides are practicable for the sectors to which they refer;

they are suitable as guides to compliance with the provisions of Articles 4, 5 and 6,
in the sectors and/or for the feeds concerned.

Member  States  shall  forward  national  guides  complying  with  the  requirements  of

4.
paragraph 2 to the Commission.

The  Commission  shall  set  up  and  run  a  registration  system  for  such  guides  and  make  this
system available to the Member States.

Article 23
Community guides

Before  Community  guides  to  good  practice  for  hygiene  or  for  the  application  of
1.
HACCP principles are developed, the Commission shall consult the Committee referred to in
Article 31 (1). The objective of that consultation shall be to consider the case for such guides,
their scope and subject matter.

Where  Community  guides  are  prepared,  the  Commission  shall  ensure  that  they  are

2.
developed and disseminated:

(a)

(b)

3.

(a)

by  or  in  consultation  with  appropriate  representatives  of  European  feed  business
sectors and other interested parties, such as consumer groups;

in collaboration with parties whose interests may be substantially affected, including
competent authorities.

Community guides shall be developed and disseminated taking into account:

relevant codes of practice of the Codex Alimentarius, and

when  they  concern  primary  production,  having  regard  to  the  requirements  set  out  in

(b)
Annex I.

The  Committee  referred  to  in  Article  31(1)  shall  assess  draft  Community  guides  to

4.
ensure that:

(a)

(b)

they have been developed in accordance with paragraphs 2 and 3;

the contents of such guides are practicable throughout the Community for the sectors
to which they refer, and

20

(c)

they are suitable as guides to compliance with the provisions of Articles 4, 5 and 6,
in the sectors and/or for the feeds concerned.

5.
The Commission shall invite the Committee referred to in Article 31(1) periodically to
review any Community guides prepared in accordance with this Article, in co-operation with
the bodies mentioned in paragraph 2. The aim of this review shall be to ensure that the guides
remain practicable and to take account of technological and scientific developments.

The  titles  and  references  of  Community  guides  prepared  in  accordance  with  this

6.
Article shall be published in the C series of the Official Journal of the European Union.

CHAPTER IV

IMPORTS

Article 24
Imports

Feed  business  operators  importing  feed  from  third  countries  shall  ensure  that

1.
importation takes place only in accordance with the following conditions:

(a)

(b)

(c)

the third country of dispatch appears on a list, drawn up in accordance with Article
48  of  Regulation  (EC)  …/…  on  official  feed  and  food  controls,  of  third  countries
from which imports of feed are permitted;

the establishment of dispatch appears on a list, drawn up and kept up-to-date by the
third country in accordance with Article 48 of Regulation (EC) on official feed and
food controls of establishments from which imports of feed are permitted;

the feed was sent from the establishment of dispatch which may also use feed from
another  establishment  appearing  on  the  list  referred  to  in  point  (b),  or  from  the
Community;

(d)

the feed satisfies:

(i)

(ii)

the  requirements  laid  down  under  this  Regulation,  and  any  other
Community legislation laying down specific hygiene rules for feed; or

those conditions recognised  by the Community to  be  at least equivalent
thereto; or

(iii) where  a  specific  agreement  exists  between  the  Community  and  the

exporting country, with requirements contained therein.

A model import certificate may be adopted in accordance with the procedure referred

2.
to in Article 31 (2).

21

Article 25
Interim measures

Pending the compilation of the lists provided for in Article 24 (1) (a) and (b), any reference to
such lists shall be interpreted as reference to the lists established on the basis of the Directive
98/51/EC14

CHAPTER V

FINAL PROVISIONS

Article26
Implementing measures

Implementing  measures  may  be  laid  down  in  accordance  with  the  procedure  referred  to  in
Article 31 (2).

Article 27
Amendments to Annexes I, II, and III

Annexes I, II and III may be amended or repealed in accordance with the procedure referred
to in Article 31 (2), to take account of:

(a)

(b)

(c)

(d)

(e)

the development of codes of good practice;

the experience  gained  from  the  implementation  of  HACCP-based  systems  pursuant
to Article 6;

technological developments;

scientific advice, particularly new risk assessments; and

the setting of feed safety targets.

Article 28
Derogations from provisions of Annexes I, II and III

Derogations from  the  provisions  of  the  Annexes  I,  II  and  III  may  be  granted  in  accordance
with the procedure referred to in Article 31 (2), provided that such derogations do not affect
the achievement of the objectives of this Regulation.

14

Commission  Directive  98/51/EC  of  9  July  1998  laying  down  certain  measures  for  implementing
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  (OJ  L  208,  24.07.98,  p.
43)

22

                                                
Article 29
National measures adapting the requirements of Annex II

1.
Member  States  may,  without  compromising  feed  hygiene  objectives,  adopt  national
measures adapting the requirements laid down in Annex II in accordance with paragraphs 2 to
5 of this Article.

2.

(a)

The national measures adapting the requirements laid down in Annex II shall:

have  the  aim  of  accommodating  the  needs  of  feed  businesses  situated  in  regions
suffering from special geographical constraints; or

(b)

concern the construction, layout and equipment of establishments.

3.
Any Member State wishing to adopt national measures adapting the requirements laid
down  in  Annex  II  shall  notify  the  Commission  and  other  Member  States.  The  notification
shall:

(a)

(b)

(c)

provide a detailed description of the requirements the Member State considers need
to be adapted and the nature of the adaptation sought;

describe the feed and establishment concerned;

explain the reasons for the adaptation (including, where relevant,  a summary of the
hazard analysis carried out and any measures to be taken to ensure that the adaptation
will not compromise hygiene objectives); and

(d)

give any other relevant information.

Other  Member  States  shall  have  three  months  from  the  receipt  of  a  notification

4.
referred to in paragraph 3 to send written comments to the Commission.

In the case of adaptations referred to in paragraph 2 (a) of this Article, this period shall, at the
request of any Member State, be extended to four months.

The Commission may – and, when it receives written comments from one or more Member
States, shall – consult Member States within the committee referred to in Article 31 (1). The
Commission  may  decide,  in  accordance  with  the  procedure  referred  to  in  Article  31  (2),
whether the measures envisaged may be implemented subject, where necessary, to appropriate
amendments.  Where  appropriate,  the  Commission  may  propose  measures  of  general
application in accordance with Articles 27 or 28.

5.
only:

(a)

(b)

A Member State may adopt national measures adapting the requirements of Annex II

in compliance with a decision adopted in accordance with paragraph 4; or

where,  one  month  after  the  expiry  of  the  period  referred  to  in  paragraph  4,  the
Commission has not informed Member States that it has received written comments
or that it intends to propose the adoption of a decision referred to in point (a)

23

Article 30
Penalties

The Member States shall  lay down the  rules on  penalties  applicable  to  infringements  of  the
provisions  of  this  Regulation  and  shall  take  the  measures  necessary  to  ensure  that  they  are
implemented. The penalties provided for must be effective, proportionate and dissuasive. The
Member  States  shall  notify  those  provisions  to  the  Commission  by  1  year  after  the  date  of
publication of this Regulation at the latest and shall notify it without delay of any subsequent
amendment affecting them.

Article 31
Standing Committee Procedure

1.
The Commission shall be assisted by the Standing Committee on the Food Chain and
Animal  Health  set  up  by  Regulation  (EC)  No  178/2002  (hereinafter  referred  to  as  “the
Committee”).

Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC

2.
shall apply, having regard to the provisions of Article 8 thereof.

The period laid down in Article 5 (6) of Decision 1999/468/EC shall be set at three months.

3.

The Committee shall adopt its rules of procedure.

Article 32
Consultation of the European Food Safety Authority

The Commission shall consult the European Food Authority on any matter within the scope of
this Regulation that could have a significant impact on public health and, in particular, before
proposing criteria or targets in accordance with Article 5 (3).

Article 33
Repeal

The  following  Directives  are  repealed,  without  prejudice  to  the  obligations  of  the  Member
States concerning the deadlines for transposition, with the effect from the date of application
of this Regulation:

(a)

(b)

Council  Directive  95/69/EC  of  22  December  1995  laying  down  the  conditions  and
arrangements for approving and registering certain establishments and intermediaries
operating  in  the  animal  feed  sector  and  amending  Directives  70/524/EEC,
74/63/EEC, 79/373/EEC and 82/471/EEC;

Commission  Directive  98/51/EC  of  9  July  1998  laying  down  certain  measures  for
implementing  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.

24

Article 34
Entry into force

This Regulation shall enter into force on the date of its publication in the Official Journal of
the European Union.

It shall apply one year after the entry into force of this Regulation

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

25

ANNEX I

Requirements for feed businesses at the level of primary production referred to in
Article 5(1)

1.
Feed  business  operators  responsible  for  primary  production  shall  ensure  that
operations  are  managed  and  carried  out  in  such  a  way  as  to  prevent,  eliminate  or  minimise
hazards  with  the  potential  to  compromise  feed  safety,  wherever  possible  taking  account,
where appropriate, of subsequent processing.

2.
Feed  business  operators  shall  ensure,  as  far  as  possible,  that  primary  products
produced,  prepared,  cleaned,  packed,  stored  and  transported  under  their  responsibility  are
protected against contamination and spoilage.

3.
Feed business operators shall meet the obligations in paragraphs 1 and 2 by complying
with  appropriate  Community  and  national  legislative  provisions  relating  to  the  control  of
hazards in primary production, including:

(i)

(ii)

4.

(a)

(b)

(c)

(d)

(e)

(f)

(g)

measures to control contamination arising  from  the  air, soil, water, fertilisers, plant
protection  products,  biocides,  veterinary  medicinal  products  and  handling  and
disposal of waste, and

measures  relating  to  plant  health,  animal  health  and  the  environment  that  have
implications for feed safety including programmes for the monitoring and control of
zoonoses and zoonotic agents.

Feed business operators shall take adequate measures, as appropriate:

to  keep  clean  and,  where  necessary  after  cleaning,  to  disinfect  in  an  appropriate
manner  facilities,  equipment,  containers,  crates  and  vehicles  used  for  producing,
preparing, grading, packing, storing and transporting feed;

to ensure, where necessary, hygienic production, transport and storage conditions for,
and the cleanliness of, feed;

to use clean water whenever necessary to prevent contamination;

to prevent, as far as possible, animals and pests from causing contamination;

to store and handle wastes and hazardous substances, separately and securely, so as
to prevent contamination;

to ensure that packaging materials are not a source of contamination of feed;

to take account of the results of any relevant analyses carried out on samples taken
from primary products or other samples relevant to feed safety.

RECORD-KEEPING

Feed business operators shall complete and retain records relating to measures put in
1.
place  to  control  hazards  in  an  appropriate  manner  and  for  an  appropriate  period,

26

commensurate  with  the  nature  and  size  of  the  feed  business.  Feed  business  operators  must
make relevant information contained in these records available to the competent authority.

2.

(a)

(b)

(c)

(d)

Feed business operators must, in particular, keep records on:

any use of plant protection products and biocides ;

use of genetically modified seeds;

any occurrence of pests or diseases that may affect the safety of primary products;

the  results  of  any  analyses  carried  out  on  samples  taken  from  primary  products  or
other samples taken for diagnostic purposes that have importance for feed safety;

3.
Other persons, such as veterinarians, agronomists and farm technicians, may assist the
feed business operators with the keeping of records relevant to the activities they carried out
in the farm.

GUIDES TO GOOD PRACTICE

National and Community guides referred to in Articles21 to 23 of this Regulation shall

1.
contain guidance on good practices for the control of hazards in primary production.

Guides  to  good  practices  shall  include  appropriate  information  on  hazards  arising  in
2.
primary  production  and  actions  to  control  hazards,  including  relevant  measures  set  out  in
Community and national legislation or national and Community programmes, such as:

(a)

(b)

(c)

(d)

(e)

(f)

(g)

(h)

the control of contamination such as mycotoxins, heavy metals, radioactive material.;

the use of water, organic waste and fertilisers;

the  correct  and  appropriate  use  of  plant  protection  products  and  biocides  and  their
traceability;

the  correct  and  appropriate  use of veterinary medicinal  products  and  feed  additives
and their traceability;

the (preparation, storage and) traceability of feed materials;

the proper disposal of dead animals, waste and litter;

protective measures to prevent the introduction of contagious diseases transmissible
to animals through feed and any obligation to notify the competent authority;

procedures, practices and methods to ensure that feed is produced, prepared, packed,
stored  and  transported  under  appropriate  hygienic  conditions,  including  effective
cleaning and pest-control;

(i)

measures relating to record-keeping.

27

Requirements for feed businesses other than at the level of primary production referred
to in Article 5 (2)

ANNEX II

FACILITIES AND EQUIPMENT

Feed processing and storage facilities, equipment, containers, crates, vehicles and their
1.
immediate surroundings  shall be kept clean, and  effective  pest control  programmes  shall  be
implemented.

2.

(a)

(b)

The lay-out, design, construction and size of the facilities and equipment shall:

permit adequate cleaning and/or disinfection

be such as to minimise the risk of error and with a view to avoiding contamination,
cross-contamination  and  any  adverse  effects  generally  on  the  safety  and  quality  of
the products. Machinery coming into contact with feed shall be dried following any
wet cleaning process.

3.
Facilities and equipment to be used for mixing and/or manufacturing operations shall
undergo  appropriate  and  regular  checks,  in  accordance  with  written  procedures  pre-
established by the manufacturer for the products.

(a)

(b)

All scales and metering devices used in the manufacture of feeds shall be appropriate
for the range of weights or volumes to be measured and tested for accuracy regularly.

All  mixers  used  in  the  manufacture  of  feeds  shall  be  appropriate  for  the  range  of
weights  or  volumes  being  mixed,  and  shall  be  capable  of  manufacturing  suitable
homogeneous mixtures and homogeneous dilutions.

4.

Facilities must have adequate natural and/or artificial lighting.

Drainage facilities must be adequate for the purpose intended; they must be designed

5.
and constructed to avoid the risk of contamination of feedingstuffs.

Water used in feed manufacture shall be of potable quality for  animals;  the conduits

6.
for water shall be of an inert nature.

7.
Sewage,  waste  and  rain  water  shall  be  disposed  of  in  a  manner  which  ensures  that
equipment  and  the  safety  and  quality  of  feed  is  not  affected.  Spoilage  and  dust  shall  be
controlled to prevent pest invasion.

Windows and other openings must, where necessary, be fitted with pest-proof netted

8.
screens. Doors must be close-fitting and pest-proof when closed.

9.
Where  necessary,  ceilings  and  overhead  fixtures  must  be  designed,  constructed  and
finished  to  prevent  the  accumulation  of  dirt  and  to  reduce  condensation,  the  growth  of
undesirable moulds and the shedding of particles that can affect the safety and quality of feed.

28

PERSONNEL

Feed businesses must have sufficient  staff  possessing the skills and qualifications  necessary
for  the  manufacture  of  the  products  concerned.  An  organization  chart  setting  out  the
qualifications (e.g. 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
product quality.

PRODUCTION

1.

A qualified person responsible for production must be designated.

2.
Feed business operators must ensure that the different stages of 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.

3.
Technical  or  organisational  measures  must  be  taken  to  avoid  or  minimise,  as
necessary,  any  cross-contamination  and  errors.  There  must  be  sufficient  and  appropriate
means of carrying out checks in the course of manufacture.

The  presence  of  prohibited  feed  materials,  undesirable  substances  and  prohibited
4.
substances and pathogens in relation to human health or animal health shall be monitored, and
appropriate control strategies to minimise the risk shall be in place.

Waste and unsaleable materials should be isolated and identified. Any such materials
5.
containing  hazardous  levels  of  veterinary  drugs,  contaminants  or  other  hazards  shall  be
disposed of in an appropriate way and not used as a feed.

QUALITY CONTROL

1.

A qualified person responsible for quality control must be designated.

2.
Feed  businesses  must,  as  part  of  a  quality  assurance  scheme,  have  access  to  a
laboratory with adequate staff and equipment to guarantee and check, before the release of the
products with a view to putting them into circulation, that they comply with the specifications
defined by the manufacturer.

3.
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  the  destination  in  the  event  of  non-compliance  -  from  processed  materials  to  final
products.

4.
Samples of ingredients and of each batch of products placed on the market or of each
specific  portion  of  production  (in  the  case  of  continuous  production)  must  be  taken  in
sufficient quantity using a procedure pre-established by  the  manufacturer  and  be  retained  in
order  to  ensure  traceability  (on  a  regular  basis  in  the  case  of  manufacture  solely  for  the
manufacturer's  own  needs).  The  samples  must  be  sealed  and  labelled  for  ease  of
identification;  they  must  be  stored  under  conditions  which  prevent  any  abnormal  change  in

29

the composition of the sample or any adulteration. They must be kept at  the  disposal  of  the
competent authorities for a period appropriate for the use to which the feed are placed in the
market.

STORAGE AND TRANSPORT

1.
Processed  feeds  shall  be  separated  from  unprocessed  feed  materials  and  additives  in
order to avoid any cross-contamination of the processed feed, and proper packaging materials
shall be used.

2.
Feeds  shall  be  stored  and  transported  in  suitable  containers.  They  shall  be  stored  in
places designed, adapted and maintained in order to ensure good storage conditions, to which
only persons authorised by the feed business operators have access.

Feeds  shall  be  stored  and  transported  in  such  a  way  as  to  be  easily  identifiable,  to

3.
avoid any confusion or cross-contamination and to prevent deterioration.

4.
Containers  and  equipment  used  for  transport,  storage,  conveying,  handling  and
weighing  shall  be  kept  clean.  Cleaning  programmes  shall  be  introduced,  and  traces  of
detergents and disinfectants shall be minimised.

5.

6.

Any spoilage shall be minimised and kept under control to reduce pest invasion.

Temperatures shall be kept as low as possible to avoid condensation and spoilage.

DOCUMENTATION

1.
All feed businesses operators, including those who act solely as traders without ever
holding  the  product  in  their  facilities,  shall  keep  in  a  register  records  with  relevant  data
comprising purchase, production and sales for effective tracing from delivery or export to the
final destination.

Feed business operators, except those who act solely as dealers without ever holding

2.
the product in their facilities, shall keep in a register the following documentation:

(a)

Documentation relating to the manufacturing process and controls.

Feed businesses must have a system of documentation designed to define and
ensure  mastery  of  the  critical  points  in  the  manufacturing  process  and  to
establish and implement a quality control plan. They must keep the results of
the relevant controls. This set of documents must be kept so that it is possible
to trace the manufacturing history of each batch of products put into circulation
and to establish responsibility if complaints arise.

(b)

Documentation relating to traceability

(i)

Additives:

-

the  nature  and  quantity  of  the  additives  produced,  the  respective
dates  of  manufacture  and,  where  appropriate,  the  number  of  the
batch  or  of  the  specific  portion  of  production,  in  the  case  of
continuous manufacture;

30

(ii)

-

-

-

the  nature  and  quantity  of  the  additives  delivered  and,  where
appropriate,  the  number  of  the  batch  or  of  the  specific  portion  of
production, in the case of continuous manufacture;

Products covered by Directive 82/471/EEC:

the nature of the products and the quantity produced, the respective
dates  of  manufacture  and,  where  appropriate,  the  number  of  the
batch  or  of  the  specific  portion  of  production,  in  the  case  of
continuous manufacture;

the name and address of the establishments or users (establishments
or  stock-breeders)  to  whom  these  products  have  been  delivered,
together  with  details  of  the  nature  and  quantity  of  the  products
delivered and, where appropriate, the number of the batch or of the
specific  portion  of  production, 
the  case  of  continuous
manufacture.

in 

(iii)

Premixtures:

(iv)

-

-

-

-

-

-

the  name  and  address  of  the  manufacturers  or  suppliers  of
additives, the nature and quantity of the additives 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  and  the  batch  number
where appropriate;

the name and address of the establishment to which the premixture
is  delivered,  the  delivery  date,  the  nature  and  quantity  of  the
premixture delivered, and the batch number where appropriate.

Compound feedingstuffs/feed materials:

the name and address of premixture manufacturers or suppliers, the
nature and quantity of the premixture used, with the batch number
where appropriate;

the name and address of the suppliers of the feed materials and the
delivery date;

feed  materials  or  compound
the  nature  and  quantity  of 
feedingstuffs manufactured, together with the date of manufacture,
and  the  name  and  address  of  the  buyer  (e.g.  stock-breeder,  other
feed businesses).

COMPLAINTS AND PRODUCT RECALL

Feed  business  operators  shall  implement  a  system  for  registering  and  processing

1.
complaints.

They shall be in a position to introduce, where this proves necessary, a system for the
2.
prompt recall of products in the distribution network. They shall 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.

31

ANNEX III

Good Animal Feeding Practice

PASTURE GRAZING

The  grazing  of  pastures  and  croplands  should  be  managed  in  a  way  that  minimises  the
contamination of foods of animal origin by biological and chemical hazards.

Where appropriate, an adequate rest period should be observed  before  allowing livestock to
graze  on  pasture,  crops  and  crop  residues  and  between  grazing  rotations  to  minimise
biological  cross-contamination  from  manure,  where  such  a  potential  problem  exists,  and  to
ensure that the withholding periods for agricultural chemical applications are observed.

STABLE FEEDING AND BATCH/INTENSIVE UNIT FEEDING

The animal production unit should be  designed so that it can be easily  cleaned.  The  animal
production unit and feeding equipment should be cleaned thoroughly and regularly to prevent
any build-up of biological hazards. Chemicals used for cleaning and sanitising should be used
according to instructions and stored away from feed and feeding areas.

A  pest  control  system  should  be  put  in  place  to  control  the  access  of  pests  to  the  animal
production unit with a view to minimising the possibility of biological contamination of feed
and bedding materials or animal units.

Buildings  and  feeding  equipment  should  be  kept  clean.  Systems  should  be  put  in  place  to
regularly  remove  manure,  waste  material  and  other  possible  sources  of  biological
contamination of feed.

Feed and bedding material used in the animal production unit should be frequently changed
and not allowed to become mouldy.

1.

Storage

FEEDING

Feed should be stored separately from chemicals. Storage areas and containers should be kept
clean and dry and free from pests that may introduce biological contaminants. Storage areas
and containers should be cleaned regularly to avoid unnecessary cross-contamination.

Seed should be stored properly and in such a way that is not accessible to animals.

Medicated  feed,  non-medicated  feed  and  compound  feedingstuffs  intended  for  different
categories or species of animals should be stored such as to reduce the risk of cross-feeding.

2.

Distribution

The  on-farm  feed  distribution  system  should  ensure  that  the  right  feed  is  sent  to  the  right
destination.  During  distribution  and  feeding,  feed  should  be  handled  in  such  a  way  as  to
ensure  that  biological  contamination  does  not  occur  from  contaminated  storage  areas  and

32

equipment.  Non-medicated  feeds  should  be  handled  separately  from  medicated  feeds  to
prevent contamination.

Feed transport vehicles and feeding equipment used to deliver and distribute medicated feed
should be cleaned periodically.

FEED AND WATER

Farmers  should  evaluate  and  minimise  the  risks  of  biological  or  chemical  contamination  of
animals through drinking water, or thorough direct contact with aquatic animals.

Feeding  and  watering  equipment  must  be  designed,  constructed  and  placed  such  that
contamination  of  feed  and  water  is  minimised.  Watering  systems  should  be  cleaned  and
maintained regularly, where possible.

Animals should be fed by  staff  possessing  the  requisite  ability,  knowledge  and  professional
competence.

PERSONNEL

33

ANNEX IV

CHAPTER 1

Additives

– 

– 

– 

– 

– 

– 

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 : all additives in the group

Trace elements: all additives in the group

Enzymes: all additives in the group

–  Micro-organisms: all additives in the group

– 

– 

Carotenoids and xanthophylls: all additives in the group

Substances with antioxidant effects: only those with a fixed maximum content

Products covered by Directive 82/471/EEC

– 

– 

– 

– 

Additives

– 

– 

– 

– 

Proteins  obtained  from  micro-organisms  belonging  to  the  group  of  bacteria,
yeasts, algae, lower fungi: all products in the group (except for subgroup 1.2.1)

Co-products of the manufacture of amino acids by fermentation: all products in
the group

Amino acids and their salts: all products in the group

Hydroxy analogues of amino acids: all products in the group

CHAPTER 2

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: A and D

– 

Trace elements: Cu and Se

34

CHAPTER 3

Additives

– 

– 

– 

Antibiotics: all additives in the group

Coccidiostats and other medicinal substances: all additives in the group

Growth promoters: all additives in the group

35

ANNEX V

CHAPTER I

I. 1. LIST OF REGISTERED FEED BUSINESSES

1

2

3

4

5

Registration
number

Activity

Name or
business
name15

Address16

Remarks

I. 2. LIST OF APPROVED FEED BUSINESSES

1

2

3

4

5

Approval
number

Activity

Name or
business
name17

Address18

Remarks

CHAPTER II

The approval number must have the following structure:

1.

The character “α” if the feed business is approved;

The ISO code of the Member State or of the third country where the feed business is

2.
located;

3.

The national reference number, to a maximum of eight alphanumerical characters.

15

16

17

18

Name or business name of the feed businesses.
Address of the feed businesses.
Name or business name of the feed businesses.
Address of the feed businesses.

36

                                                
LEGISLATIVE FINANCIAL STATEMENT

Policy area(s): Health and Consumer Protection

Activit(y/ies): Food Safety, Animal Health, Animal Welfare and Plant Health

TITLE  OF  ACTION:  REGULATION  OF  THE  EUROPEAN  PARLIAMENT  AND  OF  THE  COUNCIL

LAYING DOWN REQUIREMENTS FOR FEED HYGIENE

1.

BUDGET LINE(S) + HEADING(S)

A 701: Mission expenses, travel expenses and incidental expenditure.

A 703: Expenditure on formal and other meetings

A704:  Miscellaneous  expenditure  on  the  organisation  of  and  participation  in
conferences, congresses and other meetings.

A-705: Studies and consultations

A-707- Development of management and information systems

OVERALL FIGURES

Total allocation for action (Part B): € million for commitment

Period of application:

The activity will start in January 2005

2.

2.1.

2.2.

2.3.

Overall multiannual estimate of expenditure:

(a)

Schedule  of  commitment  appropriations/payment  appropriations 
intervention) (see point 6.1.1)

(financial

€ million (to three decimal places)

[n+1]

[n+2]

[n+3]

[n+4]

Year
[n]

[n+5
and
subs.
Years]

Total

Commitments

Payments

(b)

Technical and administrative assistance and support expenditure(see point 6.1.2)

Commitments

Payments

37

Subtotal a+b

Commitments

Payments

(c)

Overall  financial  impact  of  human  resources  and  other  administrative  expenditure
(see points 7.2 and 7.3)

0,399

0,399

0,399

0,399

0,399

0,399

Commitments/
payments

TOTAL a+b+c

Commitments

0,399

0,399

0,399

0,399

0,399

0,399

Payments

0,399

0,399

0,399

0,399

0,399

0,399

2.4.

Compatibility with financial programming and financial perspective

[X]

Proposal is compatible with existing financial programming.

Proposal  will  entail  reprogramming  of  the  relevant  heading  in  the

[…]
financial perspective.

Proposal  may 

[…]
Interinstitutional Agreement.

require  application  of 

the  provisions  of 

the

2.5.

Financial impact on revenue:

Proposal  has  no  financial  implications  (involves  technical  aspects

[X]
regarding implementation of a measure)

OR

[…]

Proposal has financial impact – the effect on revenue is as follows:

(NB All details and observations relating to the method of calculating the effect on
revenue should be shown in a separate annex.)

(€ million to one decimal place)

Budget line

Revenue

Prior to
action
[Year
n-1]

[Year
n]

Situation following action

[n+1] [n+2] [n+3] [n+4] [n+5]

a) Revenue in absolute terms

b) Change in revenue

 (cid:1)

(Please specify each budget line involved, adding the appropriate number of rows
to the table if there is an effect on more than one budget line.)

38

3.

BUDGET CHARACTERISTICS

Type of expenditure

New

EFTA
contribution

Contributions
from applicant
countries

Heading in
financial
perspective

Comp/

Diff/

YES/

NO

NO

Part A

4.

LEGAL BASIS

Articles 37 and 152(4)

5.

DESCRIPTION AND GROUNDS

5.1.

Need for Community intervention

5.1.1. Objectives pursued

This proposal corresponds to action 25 of the White Paper on Food Safety.

The  main  objective  is  to  ensure  a  high  level  of  protection  of  human  life  as  well  as  the
protection of animal health and the environment.

Furthermore, this proposal:

–  establishes feed hygiene requirements at  all stages in  the  use,  production,  processing  and

distribution of feed;

–  extends  the  registration  obligation  to  all  feed  business  operators  (including  primary

producers) wishing to place feed on the market;

–  requires  approval  in  certain  cases  where  feed  business  operators  are  dealing  with  more
sensitive substances —  in such cases,  the competent authority  will  give official  approval
following an on-the-spot visit to check compliance;

–  imposes  the  obligation  to  follow  HACCP  (Hazard  Analysis  and  Critical  Control  Point)
principles  on  all  feed  operators  other  than  those  operating  at  the  level  of  primary
production;

–  encourages  the  development  of  national  guides  to  Good  Practices  and  guides  to  the
application of HACCP and the creation of a register of such guides at Community level;

–  establishes  the  possibility  of  harmonising  guides  to  Good  Practices  and  guides  to  the

application of HACCP at Community level

–  maintains certain requirements for imports from third countries, under which they have to
comply  with  at  least  equivalent  requirements  to  those  laid  down  in  the  Regulation,  and
provides  for  the  development  of  detailed  implementation  measures  by  comitology
procedure in accordance the Regulation of the European Parliament and of the Council on
official feed and food controls;

39

–  ensures  that  feed  business  operators  provide  a  financial  guarantee  in  order  to  cover  the

risks related to their business;

–  creates conditions for equal and fair competition.

5.1.2. Measures taken in connection with ex ante evaluation

On 12 January 2000, the Commission adopted the White Paper on Food Safety (COM (1999)
719 final). This paper constitutes a wide-ranging evaluation of Community food safety policy.
The objective of the European Commission is the achievement of the highest possible level of
health protection for consumers across the EU. The White Paper sets out a plan for a radical
reform of food law based on a comprehensive, integrated approach ("farm to fork" approach)
as well as the establishment of a European Food Safety Authority.

The  White  Paper  stresses,  in  particular,  the  need  for  comprehensive  legislation  in  order  to
complete the current provisions laying down conditions for feed establishments.

5.1.3. Measures taken following ex post evaluation

Not applicable

5.2.

Action envisaged and budget intervention arrangements

General objectives: links with the overall aim.

Target  population:  consumers  are  the  ultimate  beneficiaries;  the  target  population
comprises feed producers, feed manufacturers and feed users.

The specific objectives and actions set for this regulation are:

(cid:1)  to ensure that feed  hygiene requirements  are  met  at  all  stages  in  the  production,
use, processing and distribution of feed; this objective should be achieved by the
operators  and  controlled  by  the  competent  authorities  following  the  rules  laid
down in other Community legislation;

(cid:1)  to  extend  the  registration  obligation  to  all  feed  business  operators  (including

primary producers) wishing to place feed on the market.

(cid:1)  to maintain the current system of approval for feed business operators wishing to
place on the market certain sensitive substances or feedingstuffs containing these
substances and to provide for the possible extension of this requirement to other
kind  of  products  by  comitology  procedure;  this  is  the  responsibility  of  the
Member States;

(cid:1)  to impose the obligation to follow the principles of HACCP (Hazard Analysis and
Critical Control Point) on all feed operators other than those operating at the level
of  primary  production;  this  objective  should  be  achieved  by  the  operators  and
controlled  by  the  competent  authorities  following  the  rules  laid  down  in
Community legislation;

(cid:1)  to encourage the development of national guides to Good Practices and guides to
the  application  of  HACCP  and  to  create  a  register  at  Community  level  of  such
guides; the Member States shall assess those guides while the Commission should

40

create and maintain the Community register; this action will not require additional
human resources but will require some budget allocations for the development of
management and information systems;

(cid:1)  to establish the possibility of harmonising guides to Good Practices and guides to
the  application of HACCP  at  Community  level;  this action  requires  consultation
of  the  Standing  Committee  on  the  Food  Chain  and  Animal  Health,  experts,
interested parties and Member States; the expenditure entailed by this action will
require allocations for missions, meetings of the Standing Committee and working
groups, conferences, studies or consultations;

(cid:1)  to  maintain  certain  requirements  for  imports  from  third  countries,  under  which
they have to comply with at least equivalent  requirements to those  laid  down  in
the  Regulation  and  to  provide  for  the  development  of  detailed  implementation
measures by comitology procedure in accordance with the Regulation on official
feed  and  food  controls;  the  expenditure  entailed  by  this  action  will  require
allocations  for  missions,  meetings  of  the  Standing  Committee  and  working
groups,  conferences,  studies  or  consultations  in  order  to  develop  detailed
implementation measures through a Commission Regulation;

(cid:1)  the Food and Veterinary Office (FVO), as  concerns feed, will be responsible for
making inspections to verify the effective implementation by the  Member  States
of their obligations under this Regulation; the inspections may also be extended to
third  countries;  it  is  difficult to  assess  to  what  extent  this  proposal  will  increase
the  current  tasks  of  the  FVO,  in  particular  because  the  requirements  for  third
countries  will  be  developed  later  by  a  Commission  Regulation;  where  the
Commission  Regulation  calls  for  additional  tasks,  a  specific  financial  statement
will be produced.

Impact  indicators:  number  of  operators  registered,  number  of  national  guides  to
Good Practices and guides to the application of HACCP included in the Community
Register, number of Community Guides published in the Official Journal, number of
decisions  including  implementation  measures  for  imports  from  third  countries,
number of missions by the FVO to inspect Member States and third countries.

Assessment of the results obtained: the authorisation procedure provided for by  the
Regulation guarantees a high level of protection for human health.

5.3.

Methods of implementation

Direct  management  by  the  Commission  staff  and,  in  some  actions,  in  consultation
with external experts in the field of animal nutrition.

6.

FINANCIAL IMPACT

6.1.

Total financial impact on Part B - (over the entire programming period)

(The method of calculating the total amounts set out in the table below must be explained by
the breakdown in Table 6.2. )

41

6.1.1.

Financial intervention

Commitments (in € million to three decimal places)

Breakdown

[Year
n]

[n+1]

[n+2]

[n+3]

[n+4]

Total

[n+5
and
subs.
Years]

Action 1

Action 2

etc.

TOTAL

6.1.2.

Technical  and  administrative  assistance,  support  expenditure  and  IT  expenditure
(commitment appropriations)

[Year
n]

[n+1]

[n+2]

[n+3]

[n+4]

Total

[n+5
and
subs.
years]

1) 
administrative assistance

Technical 

and

Technical 

a) 
offices

assistance

b)  Other 
administrative assistance:

technical 

and

- intra muros:

- extra muros:

of  which  for  construction
and 
of
maintenance 
computerised  management
systems

Subtotal 1

2) Support expenditure

a) Studies

b) Meetings of experts

c) Information and
publications

Subtotal 2

TOTAL

42

6.2.

Calculation  of  costs  by  measure  envisaged  in  Part  B  (over  the  entire
programming period)

(Where  there  is  more  than  one  action,  give  sufficient  detail  of  the  specific  measures  to  be
taken for each one to allow the volume and costs of the outputs to be estimated.)

Breakdown

Commitments (in € million to three decimal places)

Type
of outputs
(projects, files )

Number of
outputs

Average unit
cost

(total for years
1…n)

Total cost

(total for years
1…n)

1

2

3

4=(2X3)

Action 1

- Measure 1

- Measure 2

Action 2

- Measure 1

- Measure 2

- Measure 3

etc.

TOTAL COST

If necessary explain the method of calculation

7.

IMPACT ON STAFF AND ADMINISTRATIVE EXPENDITURE

7.1.

Impact on human resources

Types of post

Staff to be assigned to management of the
action using existing and/or additional
resources*

Number of
permanent posts

Number of
temporary posts

Total

Description of tasks deriving from the
action

Officials 
temporary staff

or

A

B

C

Other human resources

Total

2

0.5

0.5

3

1 A official will manage the
Commission tasks except those related
to inspections.

1 A official in the FVO will deal with
inspections.

2

0.5

0.5

3

43

7.2.

Overall financial impact of human resources

Type of human resources

Amount (€)

Method of calculation *

Officials

Temporary staff

Other human resources

€324.000

3x €108.000

(specify budget line)

Total

€324.000

The amounts are total expenditure for twelve months.

7.3.

Other administrative expenditure deriving from the action

Budget line

(number and heading)

Overall allocation (Title A7)

A0701 – Missions

A07030 – Meetings

A07031  –  Standing  Committee  on  the  Food  Chain  and
Animal Health
A07032 – Non-compulsory committees 1

A07040 – Conferences

A0705 – Studies and consultations

Other expenditure (specify)

Information systems A707

Other expenditure - Part A (specify)

Amount (€)

Method of calculation

12.000

7.800

31.200

2.000

20.000

2.000

2  missions  within  EU  for  two  people:
€1000/person/mission.

2mission  outside  EU  for  two  people:
€2000/person/mission.

2met./year; €650x 6experts=€3900

€3900x2=7800.

3meet/year; €10400/ meeting.

3x10.400=31.200

Total

75.000

The amounts are total expenditure for twelve months.

1 Specify the type of committee and the group to which it belongs.

I.

II.

III.

Annual total (7.2 + 7.3)

Duration of action

Total cost of action (I x II)

€399.000

indefinite

€

44

8.

FOLLOW-UP AND EVALUATION

8.1.

Follow-up arrangements

The Commission will follow up the implementation of this Regulation:

–  Member  States  shall 

list  of  approved
establishments  before  1  December  of  each  year.  Upon  request,  the  Commission
shall receive an updated version of such lists.

the  Commission  of 

inform 

the 

–  Member States shall forward to the Commission and Member States the national
guides  to  Good  Practices  and  guides  to  the  application  of  HACCP  that  they
consider comply with the requirements of the Regulation.

–  As  regards  third  countries,  appropriate  implementation  measures  will  be
developed by comitology procedure, possibly with provision for the Commission
to follow up these measures.

–  The FVO will have an important role in ensuring that Member States comply with

this regulation, and this may also be extended to third countries.

8.2.

Arrangements and schedule for the planned evaluation

The Commission has to consider yearly the effectiveness of the system on the basis
of the information submitted by the Member states and inspections by the FVO.

9.

ANTI-FRAUD MEASURES

Not applicable for the financial risks encountered.

45

IMPACT ASSESSMENT FORM

THE IMPACT OF THE PROPOSAL ON BUSINESS WITH SPECIAL REFERENCE
TO SMALL AND MEDIUM-SIZED ENTERPRISES( SMEs)

TITLE OF PROPOSAL

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  laying  down
requirements for feed hygiene.

DOCUMENT REFERENCE NUMBER

THE PROPOSAL

1.

Taking  account  of  the  principle  of  subsidiarity,  why  is  Community  legislation
necessary in this area and what are its main aims?

This proposal corresponds to action 25 of the White Paper on Food Safety.

The  main  objective  is  to  ensure  a  high  level  of  protection  of  human  life  as  well  as  the
protection of animal health and the environment.

Other objectives of this proposal are:

in  accordance,  among  other  things,  with  the  commitments  in  the  White  Paper  on
(a)
Food  Safety,  to  lay  down  general  hygiene  requirements  applicable  to  all  feed  business
operators, including the use of feed by farmers, based on:

– 
– 

good agricultural and manufacturing practices;
good feeding practices.

(b)
to  extend  the  current  system  of  registration  to  all  feed  businesses  (from  primary
production to the marketing of feed); this objective is contained in the action programme in
the Annex to the Commission’s White Paper on Food Safety;

to maintain the current system of approval for feed business operators wising to place

(c)
on the market certain sensitive substances or feed containing these substances ;

(d)
to  impose  the  obligation  to  follow  HACCP  principles  (Hazard  Analysis  and  Critical
Control  Point)  on  all  feed  operators  other  than  those  operating  at  the  level  of  primary
production;

(e)
to encourage the development of national guides to Good Practices and guides to the
application of HACCP (Hazard Analysis and Critical Control Point) and to create a register at
Community level of such guides;

to  establish  the  possibility  of  harmonising  guides  for  the  application  of  HACCP

(f)
principles at Community level;

46

to  maintain  certain  requirements  for  imports  from  third  countries  under  which  they
(g)
have  to  comply  with  at  least  equivalent  requirements  to  those  laid  down  in  this  Regulation
and  to  provide  for  the  development  of  detailed  implementation  measures  by  comitology
procedure in accordance with the Regulation on official feed and food controls;

to ensure that feed business operators provide a financial guarantee in order to cover

(h)
the risks related to their business

(i)

to create conditions for equal and fair competition.

This proposal will replace Council Directive 95/69/EC of 22 December 1995 laying down the
conditions  and  arrangements  for  approving  and  registering  certain  establishments  and
intermediaries operating in the animal feed sector19 and Commission Directive 98/51/EC of 9
July 1998 laying down certain measures for implementing Council Directive 95/69/EC laying
down  the  conditions  and  arrangements  for  approving  and  registering  certain  establishments
and intermediaries operating in the animal feed sector20.

19

20

OJ L 332, 30.12.1995; p. 15
OJ L 208, 27.7.1998; p. 43

47

                                                
The  main  differences  between  this  proposal  and  Directive  95/69/EC  are  summarised  in  the
following table:

DIRECTIVE 95/69/EC

PROPOSAL 
LAYING 
REQUIREMENTS

FOR  A  REGULATION
FEED  HYGIENE

DOWN 

Scope

Scope

Establishments  and  intermediaries  producing
or  using  certain  additives  and  feed  materials
for the preparation of feed

Feed  business  operators  at  all  stages,  from  and
including primary production up to and including
the  placing  on  the  market  of  feed.  It  shall  not
apply to:

–  the  private  domestic  production  of  feed  for
food-producing  animals  for  private  domestic
consumption  and  for  animals  not  kept  for
food production;

–  the  feeding  of  food-producing  animals  for
private domestic consumption and of animals
not kept for food production;

–  the  direct  supply  of  small  quantities  of
the

level  by 

local 

primary  products  at 
producer to local farms;

Requirements  for  certain  establishments
and intermediaries.

Requirements 
production for certain establishments.

to  ensure 

the  quality  of

–  the retailing of petfood

Requirements  for  all  feed  business  operators
(including intermediaries) and users.

Hygiene requirements are established for all feed
business operators and users.

National registration of establishments and
intermediaries: the operator must submit a
declaration of its activity to the competent
authority of the Member state.

feed  business
registration  of 
National 
operators: 
the  operator  must  submit  a
declaration  of  its  activity  to  the  competent
authority of the Member state.

All  feed  business  operators  and  intermediaries
wishing  to  place  feed  on  the  market  shall  be
registered

Registration is mandatory for:

-  establishments  producing  certain  additives
and premixtures

- establishments using certain additives in the
production of feed;

-  intermediaries  of  certain  additives  and
premixtures.

48

DIRECTIVE 95/69/EC

National  approval  of 
establishments:
operators  must  submit  an  application  to  the
competent  authority  of  the  Member  State.
Authorisation  is  granted  within  6  months
after on-the-spot verification.

Mandatory  approval 
following
establishments  and  intermediaries  by  the
competent authorities of the Member States:

the 

for 

-  establishments  producing  certain  additives,
premixtures and feed materials (bioproteins);

-  establishments  using  certain  additives  for
the production of feed;

PROPOSAL  FOR  A  REGULATION
LAYING  DOWN  FEED  HYGIENE
REQUIREMENTS

feed  business
National  approval  of 
operators:  operators  must 
an
submit 
application  to  the  competent  authority  of  the
Member state.

required  where 

feed
Approval  will  be 
business operators are dealing and placing on
the  market  more  sensitive  substances,  or
feedingstuffs  containing 
these  substances,
and provision is made for this requirement to
be  extended  to  other  kind  of  products  by
comitology procedure

intermediaries 

- 
premixtures and feed materials.

of 

certain 

additives,

Specific hygiene requirements

Specific hygiene requirements

No specific hygiene requirements

Good Practices applicable to all feed business
operators  and  when  feeding  food  producing
animals.  Procedures 
following  HACCP
(Hazard Analysis and  Critical  Control  Point)
principles are mandatory for all feed business
operators  other  than  those  operating  at  the
level of primary production.

National guides

National guides

No provisions on this matter.

Encourages 
the  development  of  national
guides  to  Good  Practices  and  guides  to  the
application  of  HACCP  and  the  creation  of  a
register at Community level.

49

DIRECTIVE 95/69/EC

PROPOSAL  FOR  A  REGULATION
LAYING  DOWN  FEED  HYGIENE
REQUIREMENTS

Community Guides

Community Guides

No provisions on this matter

Establishes  the  possibility  of  harmonising
guides  to  Good  Practices  and  guides  to  the
application of HACCP at Community level

Imports from third countries

Imports from third countries

Maintains  the  principle  of  equivalence  and
provides  for  the  development  of  detailed
implementation  measures  by  comitology
procedure  in  accordance  the  Regulation  on
official feed and food controls

Provisions  for  imports  from  third  counties
based on the principle of equivalence:

–  list of third countries.

–  list  of  establishments 

in 

those 

third

countries.

–  possibility  of  carrying  out  on-the-spot

checks.

Detailed  arrangements  on  those  provisions
established by comitology procedure.

Financial guarantees

Financial guarantees

No provisions on this matter.

Operators  shall  provide  financial  guarantees
to cover the risks related to their business.

The main purpose of the current Directive 1995/69/EC of 22 December 1995 laying down the
conditions  and  arrangements  for  approving  and  registering  certain  establishments  and
intermediaries  operating  in  the  animal  feed  sector  (as  last  amended  by  Council  Directive
1999/29/EC of 22 April 1999) is to ensure that certain establishments and intermediaries that
manufacture,  produce  or  put  into  circulation  (including  importation)  certain  additives,
premixtures,  compound  feedingstuffs  and  products  covered  by  Directive  82/471/EEC  are
approved  or  registered  by  competent  authorities  that  verify  compliance  with  the  technical
specifications detailed in the annexes.

The  putting  into  circulation  of  some  of  the  products  requires  only  registration,  based  on  an
undertaking by the establishment to comply with a number of conditions.

The putting into circulation of some other products requires approval of the plant on the basis
of  very  strict  conditions  designed  to  safeguard  animals,  humans  and  the  environment.  Such
approval is subject to mandatory on-the-spot verification by the competent authority that the
conditions laid down in the Directive have been complied with.

50

THE IMPACT ON BUSINESS

2.

Who will be affected by the proposal?

–  which sectors of business: all feed businesses

–  which  sizes  of  business  (what  is  the  concentration  of  small  and  medium-sized
firms):  all  sizes,  at  all  stages  from  primary  production  up  to  and  including  the
placing on the market of feed for the final user.

–  are there particular geographical areas of the Community where these businesses
are found: The proposal has a similar impact over the entire Community. It is not
aimed at any particular region. Feed businesses are situated all over the territory
of  the  Community,  including  regions  suffering  from  special  geographical
constraints.

3.

What will business have to do to comply with the proposal?

They  must  ensure  conformity  with  general  hygiene  requirements  (facilities  and
equipment,  record-keeping,  etc.),  apply  codes  of  good  practice,  apply  the  Hazard
Analysis Critical Control Point (HACCP) system (other than at the level of primary
production), and provide financial guarantees in order to operate in the feed sector.

4.

What economic effects is the proposal likely to have?

–  on employment: neutral

–  on investment and the creation of new businesses: New obligations may however
call for additional organisational efforts, in particular the obligation  for certain
feed  businesses  to  obtain  approval  from  the  competent  authority  and  the
obligation  to  implement  a  full  HACCP  system.  An  approval  and  registration
system already applies at present. It is not expected that the proposed rules will
require  additional  investment  to  bring  businesses  up  to  the  required  standard,
apart from the provisions to provide a financial guarantee to operate in the feed
sector.

–  on the competitiveness of businesses: the proposal aims to improve feed safety.
When correctly implemented and if feed businesses assume their responsibilities,
consumer confidence should increase, which could benefit businesses.

5.

Does the proposal contain measures to take account of the specific situation of small
and medium-sized firms (reduced or different requirements etc.)?

Measures  to  facilitate  the  implementation  of  the  Hazard  Analysis  and  Critical
Control Point (HACCP) system in small businesses are planned. Account is taken of
the specificity of different ways of feed production and manufacturing. Furthermore,
Member  States  may,  without  compromising  feed  hygiene  objectives,  adopt  national
measures  adapting  the  requirements  laid  down  in  the  Regulation.  Such  measures
may  be  aimed  at  accommodating  the  needs  of  feed  businesses  situated  in  regions
suffering from special geographical constraints or concern the  construction, layout
and equipment of establishments.

51

CONSULTATION

6.

List the organisations that have been consulted about the proposal and outline  their
main views.

COPA-COGECA,  FEDESA  (European  Federation  of  Animal  Health),  FEDIAF  (Federation
Europeenne  de  l’Industrie  des  aliments  pour  Animaux  Familiers),  FEFAC  (European  Feed
Manufacturers  Federation),  FEFANA  (European  Federation  of  the  Animal  Feed  Additive
Manufacturers),  COCERAL  (Comité  du  Commerce  des  céréales,  aliments  du  bétail,
oléagineux,  huile  d'olive,  huiles  et  graisses  et  agrofournitures),  BEUC  (The  European
Consumers' Organisation)

These  organisations  welcomed  the  proposal  in  particular  with  regard  to  the  obligation  of
registration  of  the  entire  universe  of  feed  businesses  and  to  the  obligation  of  implementing
HACCP  by  all  feed  businesses  operators  other  than  those  operating  at  the  level  of  primary
production (farms).

52