Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene  (Text with EEA relevance)
Date: 2005-01-12
Institutions: Council of the European Union, European Parliament
Subjects: European standard, animal feedingstuffs, food hygiene, food industry, food inspection, food safety, traceability

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I

(Acts whose publication is obligatory)

REGULATION (EC) No 183/2005 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 12 January 2005

laying down requirements for feed hygiene

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(3)

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

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and
Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251
of the Treaty (2),

Whereas:

(1)

(2)

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

The pursuit of a high level of protection of human and ani-
mal health is one of the fundamental objectives of food
law, as 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 Author-
ity and laying down procedures in matters of
food
safety (3). 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.

Council Directive 95/69/EC (4) established the conditions
and arrangements applicable to certain categories of estab-
lishments 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. That Directive also
established conditions for the approval of establishments
in Council
substances
producing
Directive 82/471/EEC of 30 June 1982 concerning certain
products used in animal nutrition (5).

certain

listed

(4)

(5)

(6)

Commission Directive 98/51/EC of 9 July 1998 laying
down certain measures
implementing Council
for
Directive 95/69/EC laying down the conditions and
arrangements for approving and registering certain estab-
lishments and intermediaries operating in the animal feed
sector (6), established certain measures that
included
arrangements for imports from third countries.

Experience has also shown that it is necessary to ensure
that all feed businesses, including aquaculture, operate in
conformity with harmonised safety requirements and that
it is necessary to conduct a general review in order to take
into account the need to ensure a higher level of protec-
tion of human and animal 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 pro-
tection with regard to food and feed safety, taking particu-
lar account of the following principles:

(a)

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

(1) OJ C 32, 5.2.2004, p. 97.
(2) Opinion of the European Parliament of 31 March 2004 (not yet pub-
lished in the Official Journal) and Council Decision of 21 December
2004.

(3) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC)

(4) OJ L 332, 30.12.1995, p. 15. Directive as last amended by Regulation

(EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).

(5) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

No 1642/2003 (OJ L 245, 29.9.2003, p. 4).

(6) OJ L 208, 24.7.1998, p. 43.

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(b)

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;

(c)

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 busi-
ness operators’ responsibility;

(d)

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;

that the risk is less if feed is produced and used for feeding
animals only used for domestic consumption, or for ani-
mals which are not used for food production. The trade of
small quantities of feed products at local level and the
retailing of pet food shall have particular treatment in the
framework of this Regulation.

(11)

The application of HACCP principles to primary produc-
tion of feed is the medium-term objective of European
hygiene legislation. But guides to good practice should
already be encouraging the use of appropriate hygiene
requirements.

(e)

the establishment of microbiological criteria based on
scientific risk criteria;

(12)

(f)

the need to ensure that imported feed attains a stan-
dard that is at least equivalent to that of feed produced
in the Community.

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 opera-
tors’ compliance. In addition, feed business operators
should take measures or adopt procedures to achieve a
high level of feed safety.

In order to ensure the complete application of the registra-
tion and approval system to all the feed business operators
and, consequently, to guarantee full traceability, it is appro-
priate to ensure that they only source and use feed from
establishments which are registered and/or approved in
accordance with this Regulation.

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

An integrated approach is necessary to ensure feed safety
from, and including, primary production of feed up to, and
including, its placing on the market or export. The primary
production of feed includes products which only undergo
simple physical treatment such as cleaning, packaging,
storage, natural drying or ensiling.

In accordance with the principles of proportionality and
subsidiarity, Community rules should not apply to certain
cases of private domestic production of feed and feeding of
certain animals, nor to the direct supply of small quanti-
ties of primary production of feed at local level, nor to the
retailing of pet food.

(10)

Feed hazards present at the level of primary production of
feed should be identified and adequately controlled, to
ensure that the objectives of this Regulation are met. The
fundamental principles of 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. It should be taken into
consideration

(14)

The implementation of the HACCP principles requires the
full cooperation and commitment of feed businesses’
employees.

(15) HACCP principles in feed production should take into
account the principles contained in the Codex Alimenta-
rius, but should allow sufficient flexibility in all situations.
In certain feed business, it is not possible to identify criti-
cal control points and, in some cases, good practices can
replace the monitoring of critical control points. Similarly,
the requirement to establish ‘critical limits’, as set out in the
Codex Alimentarius, does not require a numerical limit to
be fixed in every case. The requirement to retain docu-
ments as set out in the same Code needs to be flexible to
avoid undue burdens for very small businesses. It should be
ensured that operations carried out by a feed business at
the level of primary production of feed, including associ-
ated operations, as well as the mixing of feed with comple-
mentary feedingstuffs for the exclusive requirements of its
own holding, are not obliged to follow the HACCP
principles.

(7)

(8)

(9)

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(16)

Flexibility is also necessary to accommodate the needs of
feed businesses situated in regions suffering from special
geographical constraints or related to structural require-
ments. But such flexibility should not compromise feed
hygiene objectives. Provision should be made for discus-
sion within the Standing Committee on the Food Chain
and Animal Health, where appropriate.

(22)

Successive feed crises have shown that failures at any stage
in the feed chain can have important economic conse-
quences. The characteristics of feed production and the
complexity of the feed distribution chain mean that it is
difficult to withdraw feed from the market. The costs of
rectifying the economic damage 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.
However, establishing a general mandatory system of
financial liability and financial guarantees, for example
through insurance, which applies to all feed business
operators may not be feasible or appropriate. The Com-
mission should therefore consider this issue in greater
depth, taking into account provisions in existing legislation
with regard to liability in other spheres, as well as existing
systems and practices amongst the Member States. To this
end, the Commission should present a report, accompa-
nied where appropriate by legislative proposals.

(23)

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)
No 882/2004 of the European Parliament and of the Coun-
cil of 29 April 2004 on official controls performed to
ensure the verification of compliance with feed and food
law, animal health and animal welfare rules (1). In order to
avoid trade disruptions it is appropriate that, pending the
completion of the implementing measures, imports con-
tinue to be authorised under the conditions laid down in
Directive 98/51/EC.

(24)

Community products exported to third countries have to
satisfy the general requirements laid down in Regulation
(EC) No 178/2002.

(25)

It is appropriate to broaden the scope of the rapid alert sys-
tem for food and feed laid down by Regulation (EC)
No 178/2002 to include risks to animal health or the envi-
ronment from feed used for animals not kept for food
production.

(17) 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 and to facilitate the implementation of effective
official controls. The existing systems for collection of data
concerning feed businesses may be used by the competent
authority of the Member States to start up and implement
the system provided for in this Regulation.

(18)

It is appropriate that an approval system for feed busi-
nesses 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 provided for in Directive 95/69/EC.

(19)

In order to be approved or registered, feed businesses
should meet several conditions relevant to their operations,
concerning facilities, equipment, personnel, production,
quality control, storage and documentation, in order to
ensure both feed safety and product traceability. Provision
should be made for these conditions to be varied, to ensure
that they are appropriate to the various types of feed busi-
ness. Member States should be allowed to grant condi-
tional approval of establishments, if it appears from the
on-site visit that the establishment meets all the infrastruc-
ture and equipment requirements. However,
it is also
appropriate to set a maximum length of time for such con-
ditional approval.

(20)

Provision should be made for temporarily suspending,
amending or revoking the registration or approval, where
establishments change or cease their activities or no longer
fulfil the conditions applicable to their activity.

(26)

Community legislation on feed hygiene has to be under-
pinned by scientific advice. To this end, the European Food
Safety Authority should be consulted whenever necessary.

(21)

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 pro-
vides a procedure for the adoption of implementing rules
applicable to specific sectors.

(27)

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

(1) OJ L 165, 30.4.2004, p. 1 (Corrigendum: OJ L 191, 28.5.2004, p. 1).

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(28)

(29)

(30)

This Regulation takes account of international obligations
laid down in the WTO Sanitary and Phytosanitary Agree-
ment and the international food safety standards contained
in the Codex Alimentarius.

The Member States should lay down rules on penalties
applicable to infringements of the provisions of this Regu-
lation and ensure that they are implemented. Those penal-
ties have to be effective, proportionate and dissuasive.

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 con-
ferred on the Commission (1).

(31)

It is appropriate to provide for a deferred date of applica-
tion of the Regulation, in order to allow the feed businesses
affected by it time to adapt.

(32)

For the above reasons, Directives 95/69/EC and 98/51/EC
should be repealed,

HAVE ADOPTED THIS REGULATION:

(b)

the feeding of food-producing animals;

(c)

imports and exports of feed from and to third countries.

2.

This Regulation shall not apply to:

(a)

the private domestic production of feed:

(i)

for food-producing animals kept for private domestic
consumption;

and

(ii)

for animals not kept for food production;

(b)

the feeding of food-producing animals kept for private
domestic consumption or for the activities mentioned in
Article 1(2)(c) of Regulation (EC) No 852/2004 of the Euro-
pean Parliament and of the Council of 29 April 2004 on the
hygiene of foodstuffs (2);

CHAPTER I

SUBJECT MATTER, SCOPE AND DEFINITIONS

(c)

the feeding of animals not kept for food production;

Article 1

Subject matter

(d)

the direct supply of small quantities of primary production of
feed at local level by the producer to local farms for use on
those farms;

This Regulation lays down:

(e)

the retailing of pet food.

(a) general rules on feed hygiene;

(b) conditions and arrangements ensuring traceability of feed;

(c)

conditions and arrangements for registration and approval of
establishments.

Article 2

Scope

1.

This Regulation shall apply to:

3. Member States may 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 the following specific
definitions:

(a)

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

(a)

‘feed hygiene’ means the measures and conditions necessary
to control hazards and to ensure fitness for animal consump-
tion of a feed, taking into account its intended use;

(1) OJ L 184, 17.7.1999, p. 23.

(2) OJ L 139, 30.4.2004, p. 1. (Corrigendum: OJ L 226, 25.6.2004, p. 3).

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(b)

‘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;

Article 5

Specific obligations

(c)

‘feed additives’ means substances or micro-organisms autho-
rised under Regulation (EC) No 1831/2003 of the European
Parliament and of the Council of 22 September 2003 on
additives for use in animal nutrition (1);

For operations at the level of primary production of feed

1.
and the following associated operations:

(a)

transport, storage and handling of primary products at the
place of production;

(d)

‘establishment’ means any unit of a feed business;

(b)

transport operations to deliver primary products from the
place of production to an establishment;

(e)

‘competent authority’ means the authority of a Member State
or of a third country designated to carry out official controls;

(c) mixing of feed for the exclusive requirements of their own
holdings without using additives or premixtures of additives
with the exception of silage additives,

(f)

‘primary production of feed’ means the production of agri-
cultural products, including in particular growing, harvest-
ing, milking, rearing of animals (prior to their slaughter) or
fishing resulting exclusively in products which do not
undergo any other operation following their harvest, collec-
tion or capture, apart from simple physical treatment.

CHAPTER II

OBLIGATIONS

Article 4

General obligations

1.
Feed business operators shall ensure that all stages of pro-
duction, processing and distribution under their control are car-
ried out in accordance with Community legislation, national law
compatible therewith, and good practice. They shall ensure in par-
ticular that they satisfy the relevant hygiene requirements laid
down in this Regulation.

2. When feeding food-producing animals, farmers shall take
measures and adopt procedures to keep the risk of biological,
chemical and physical contamination of feed, animals and animal
products as low as reasonably achievable.

feed business operators shall comply with the provisions in
Annex I, where relevant for the operations carried out.

2.
For operations other than those referred to in paragraph 1,
including mixing of feed for the exclusive requirements of their
own holdings when using additives or premixtures of additives
with the exception of silage additives, feed business operators
shall comply with the provisions in Annex II, where relevant for
the operations carried out.

3.

Feed business operators shall:

(a)

comply with specific microbiological criteria;

(b)

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).

4.
Feed business operators may use the guides provided for in
Chapter III to help them comply with their obligations under this
Regulation.

(1) OJ L 268, 18.10.2003, p. 29.

Farmers shall comply with the provisions set out

5.
Annex III when feeding food-producing animals.

in

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Feed business operators and farmers shall only source and
6.
use feed from establishments which are registered and/or
approved in accordance with this Regulation.

As part of the system of procedures referred to in para-
4.
graph 1, feed business operators may use guides to good practice
in conjunction with guides on the application of HACCP, devel-
oped in accordance with Article 20.

Article 6

Hazard analysis and critical control points (HACCP)
system

5. Measures to facilitate the implementation of this Article,
including for small businesses, may be adopted in accordance
with the procedure referred to in Article 31(2).

1.
Feed business operators carrying out operations other than
those referred to in Article 5(1) shall put in place, implement and
maintain, a permanent written procedure or procedures based on
the HACCP principles.

Article 7

Documents concerning the HACCP system

2.

The principles referred to in paragraph 1 are the following:

1.

Feed business operators shall:

(a)

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

(a) provide the competent authority with evidence of their com-
pliance with Article 6 in the form requested by the compe-
tent authority;

(b)

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;

(b) ensure that any documents describing the procedures devel-
oped in accordance with Article 6 are up-to-date at all times;

(c)

establish critical limits at critical control points which sepa-
rate acceptability from unacceptability, for the prevention,
elimination or reduction of identified hazards;

(d) establish and implement effective monitoring procedures at

critical control points;

(e)

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

(f)

establish procedures to verify that the measures outlined in
points (a) to (e) are complete and working effectively. Verifi-
cation procedures shall be carried out regularly;

(g) establish documents and records commensurate with the
nature and size of the feed businesses to demonstrate the
effective application of the measures set out in points (a)
to (f).

3. When any modification is made in a product, process or
any stage of production, processing, storage and distribution, feed
business operators shall review their procedure and make the nec-
essary changes.

The competent authority shall take into account the nature
2.
and size of the feed business when fixing requirements as to the
form referred to in paragraph 1(a).

3.
this
Detailed arrangements for the implementation of
Article may be adopted in accordance with the procedure referred
to in Article 31(2). Such arrangements may facilitate certain feed
business operators’ implementation of HACCP principles devel-
oped in accordance with Chapter III, with a view to complying
with the requirements of Article 6(1).

Article 8

Financial guarantees

1.
To prepare for an effective system of financial guarantees
for feed business operators, the Commission shall submit to the
European Parliament and to the Council by 8 February 2006 a
report on financial guarantees in the feed sector. In addition to
examining the existing national legal provisions, systems and
practices relating to liability in the feed sector and related sectors,
the report shall be accompanied, where appropriate, by legisla-
tive proposals for such a feasible and practicable guarantee sys-
tem at Community level. Those guarantees should provide cover
for the total costs for which operators could be held liable as a
direct consequence of the withdrawal from the market, treatment
and/or destruction of any feed, animals and food produced
therefrom.

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Feed business operators shall be liable for any infringements
2.
of the relevant legislation on feed safety and operators within the
meaning of Article 5(2) shall submit proof that they are covered
by the financial guarantees required by the Community legisla-
tive measures referred to in paragraph 1.

Article 9

Official controls, notification and registration

1.
Feed business operators shall cooperate with the competent
authorities, in accordance with the relevant Community legisla-
tion and national law compatible therewith.

(b) manufacturing and/or placing on the market of premix-
tures prepared using feed additives referred to in Chap-
ter 2 of Annex IV to this Regulation;

(c) manufacturing for placing on the market, or producing
for the exclusive requirements of their holdings, com-
pound feedingstuffs using feed additives or premixtures
containing feed additives and referred to in Chapter 3 of
Annex IV to this Regulation;

(2) approval is required under the national law of the Member

State where the establishment is located;

or

2.

Feed business operators shall:

(3) approval is required by a Regulation adopted in accordance

with the procedure referred to in Article 31(2).

(a) notify the appropriate competent authority of any establish-
ments under their control, active in any of the stages of pro-
duction, processing, storage, transport or distribution of feed,
in the form required by the competent authority with a view
to registration;

Article 11

Requirements

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

Feed business operators shall not operate without:

(a)

registration as provided for in Article 9;

or

The competent authority shall maintain a register or regis-

3.
ters of establishments.

(b) approval, when required in accordance with Article 10.

Article 10

Approval of feed business establishments

Article 12

Information on national rules on approval

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

Any Member State requiring the approval under Article 10(2) of
certain establishments located on its territory shall inform the
Commission and the other Member States of the relevant national
rules.

(1)

such establishments carry out one of the following activities:

Article 13

Approval of establishments

(a) manufacturing and/or placing on the market of feed
additives covered by Regulation (EC) No 1831/2003 or
products covered by Directive 82/471/EEC and referred
to in Chapter 1 of Annex IV to this Regulation;

1.
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.

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The competent authority may grant conditional approval if
2.
it appears, from the on-site visit, that the establishment meets all
the infrastructure and equipment requirements. It shall grant full
approval only if it appears, from a new on-site visit carried out
within three months of granting conditional approval, that the
establishment meets the other requirements referred to in para-
graph 1. If clear progress has been made, but the establishment
still does not meet all of these requirements, the competent
authority may prolong conditional approval. However, condi-
tional approval shall not exceed a total of six months.

Article 17

Exemption from on-site visits

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

Article 14

Suspension of registration or approval

2.
Such feed businesses shall submit to the competent author-
ity a declaration, in a form decided upon by the competent
authority, to the effect that the feeds placed on the market by
them comply with the conditions of this Regulation.

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

Article 18

Transitional measures

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

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

(a)

the establishment ceases one or more of its activities;

(b)

it is shown that the establishment has not fulfilled the con-
ditions applicable to its activities, for a period of one year;

(c)

it identifies serious deficiencies or has had to stop produc-
tion at an establishment repeatedly and the feed business
operator is still not able to provide adequate guarantees
regarding future production.

1.
Establishments and intermediaries approved and/or regis-
tered in accordance with Directive 95/69/EC may continue their
activities, on condition that they submit, by 1 January 2006, a
notification to this effect to the relevant competent authority in
whose area their facilities are located.

2.
Establishments and intermediaries requiring neither regis-
tration nor approval in accordance with Directive 95/69/EC, but
requiring registration in accordance with this Regulation may
continue their activities, on condition that they submit, by
1 January 2006, an application for registration to the relevant
competent authority in whose area their facilities are located.

By 1 January 2008 the applicant must declare, in a form
3.
decided upon by the competent authority, that the conditions laid
down in this Regulation are being met.

4.
The competent authorities shall take account of the systems
already existing for the collection of data and request the notifier
or the applicant to provide only additional information which
guarantees compliance with the conditions of this Regulation. In
particular, the competent authorities may consider as an applica-
tion under paragraph 2 a notification pursuant to Article 6 of
Regulation (EC) No 852/2004.

Article 16

Amendments to registration or approval of an
establishment

Article 19

List of registered and approved establishments

Upon request, the competent authority shall amend the registra-
tion or approval of an establishment, where it has demonstrated
its capacity to develop activities which are additional to those for
which it was first registered or approved, or which replace them.

1.
For each activity, the competent authority shall record in a
national list or lists the establishments it has registered in accor-
dance with Article 9.

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Establishments approved by the competent authority in
2.
accordance with Article 13 shall be recorded in a national list,
under an individual identifying number.

Article 21

National guides

3. Member States shall keep updated the records of establish-
ments in the lists referred to in paragraphs 1 and 2 in accordance
with the decisions referred to in Articles 14, 15 and 16 to sus-
pend, revoke or amend registration or approval.

The list referred to in paragraph 2 must be drawn up in

4.
accordance with the model set out in Annex V, Chapter I.

The identifying number referred to in paragraph 2 shall be

5.
in the form set out in Annex V, Chapter II.

1. When national guides to good practice are developed, they
shall be developed and disseminated by feed business sectors:

(a)

in consultation with representatives of parties whose inter-
ests may be substantially affected, such as competent authori-
ties and user groups;

(b) having regard to relevant codes of practice of the Codex

Alimentarius;

and

6.
The Commission shall compile and make available to the
public the part of the Member States’ lists which includes the
establishments referred to in paragraph 2 for the first time in
November 2007, and thereafter each year, by 30 November at the
latest. The compiled list shall take into account the amendments
made during the year.

(c) when they concern primary production of feed, having regard

to the requirements set out in Annex I.

2. Member States shall assess national guides to ensure that:

The Member States shall make available to the public the

7.
lists of establishments referred to in paragraph 1.

(a)

they have been developed in accordance with paragraph 1;

(b)

their contents are practicable for the sectors to which they
refer;

CHAPTER III

GUIDES TO GOOD PRACTICE

and

Article 20

Development, dissemination and use of guides

1.
The Commission shall encourage the development of Com-
munity guides to good practice in the feed sector and for the
application of HACCP principles in accordance with Article 22.

Where necessary, Member States shall encourage the develop-
ment of national guides in accordance with Article 21.

The dissemination and use of both national and Commu-

2.
nity guides shall be encouraged by the competent authorities.

Nevertheless, feed business operators may use these guides

3.
voluntarily.

(c)

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

3. Member States shall
Commission.

transmit national guides to the

The Commission shall set up and run a registration system

4.
for such guides and make it available to the Member States.

Article 22

Community guides

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

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2. Where Community guides are prepared, the Commission
shall ensure that they are developed and disseminated:

CHAPTER IV

IMPORTS AND EXPORTS

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

Article 23

Imports

(b)

in collaboration with parties whose interests may be substan-
tially affected, including competent authorities.

Feed business operators importing feed from third countries
1.
shall ensure that importation takes place only in accordance with
the following conditions:

Community guides shall be developed and disseminated

3.
taking into account:

(a)

relevant codes of practice of the Codex Alimentarius,

and

(b) when they concern primary production of feed, the require-

ments set out in Annex I.

(a)

(b)

the third country of dispatch appears on a list, drawn up in
accordance with Article 48 of Regulation (EC) No 882/2004,
of third countries from which imports of feed are permitted;

the establishment of dispatch appears on a list, drawn up and
kept updated by the third country in accordance with
Article 48 of Regulation (EC) No 882/2004, of establish-
ments from which imports of feed are permitted;

(c)

the feed was produced by the establishment of dispatch or by
another establishment appearing on the list referred to in
point (b) or in the Community;

and

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

4.
Community guides to ensure that:

(d)

the feed satisfies:

(a)

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

(i)

the requirements laid down in this Regulation, and in
any other Community legislation laying down rules for
feed;

or

(b)

their contents are practicable throughout the Community for
the sectors to which they refer;

(ii)

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

and

or

(c)

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

(iii) where a specific agreement between the Community and
the exporting country exists, the requirements contained
therein.

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

A model import certificate may be adopted in accordance

2.
with the procedure referred to in Article 31(2).

Article 24

Interim measures

6.
The titles and references of Community guides prepared in
accordance with this Article shall be published in the C series of
the Official Journal of the European Union.

By way of derogation from Article 33 and pending the drawing
up of the lists provided for in Article 23(1)(a) and (b), imports
shall continue to be authorised under the conditions laid down in
Article 6 of Directive 98/51/EC.

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Article 25

Exports

Article 29

Rapid Alert System

Feed, including feed for animals not kept for food production,
which is produced in the Community for placing on the market
in third countries, must satisfy the provisions of Article 12 of
Regulation (EC) No 178/2002.

Should a specific feed, including feed for animals not kept for
food production, present a serious risk to human or animal health
or to the environment, Article 50 of Regulation (EC) No 178/2002
shall apply mutatis mutandis.

CHAPTER V

FINAL PROVISIONS

Article 26

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 in accordance with the pro-
cedure referred to in Article 31(2), to take account of:

(a)

the development of codes of good practice;

(b)

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

(c)

technological developments;

(d)

scientific advice, particularly new risk assessments;

Article 30

Penalties

The Member States shall lay down the rules on penalties appli-
cable to infringements of this Regulation and shall take the mea-
sures necessary to ensure that they are implemented. The penal-
ties provided for must be effective, proportionate and dissuasive.
The Member States shall notify those provisions to the Commis-
sion by 8 February 2007, and shall notify it without delay of any
subsequent amendment affecting them.

Article 31

Committee Procedure

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

2. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply, having regard to the pro-
visions of Article 8 thereof.

(e)

the setting of feed safety targets;

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

and

(f)

the development of
operations.

requirements

relating to specific

Article 28

Derogations from Annexes I, II and III

3.

The Committee shall adopt its rules of procedure.

Article 32

Consultation of the European Food Safety Authority

Derogations from Annexes I, II and III may be granted in accor-
dance with the procedure referred to in Article 31(2) for particu-
lar reasons, provided that such derogations do not affect the
achievement of the objectives of this Regulation.

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

targets

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Article 33

Repeal

Article 34

Entry into force

The following Directives are repealed, without prejudice to the
obligations of the Member States concerning the deadlines for
transposition, with effect from 1 January 2006:

(a) Council Directive 95/69/EC;

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

(b) Commission Directive 98/51/EC.

It shall apply as from 1 January 2006.

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

Done at Strasbourg, 12 January 2005.

For the European Parliament
The President
J. P. BORRELL FONTELLES

For the Council
The President
N. SCHMIT

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ANNEX I

PRIMARY PRODUCTION

PART A

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

I. Hygiene provisions

1. Feed business operators responsible for primary production of feed shall ensure that operations are managed and car-
ried out in such a way as to prevent, eliminate or minimise hazards with the potential to compromise feed safety.

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 set out in points 1 and 2 by complying with appropriate Community

and national legislative provisions relating to the control of hazards, including:

(i) measures to control hazardous contamination such as that arising from the air, soil, water, fertilisers, plant protec-

tion products, biocides, veterinary medicinal products and handling and disposal of waste,

and

(ii) measures relating to plant health, animal health and the environment that have implications for feed safety, includ-

ing programmes for the monitoring and control of zoonoses and zoonotic agents.

4. Where appropriate, feed business operators shall take adequate measures, in particular:

(a) to keep clean and, where necessary after cleaning, to disinfect in an appropriate manner, facilities, equipment, con-

tainers, crates and vehicles used for producing, preparing, grading, packing, storing and transporting feed;

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

(c) to use clean water whenever necessary to prevent hazardous contamination;

(d) to prevent, as far as possible, animals and pests from causing hazardous contamination;

(e) to store and handle wastes and hazardous substances, separately and securely, so as to prevent hazardous

contamination;

(f)

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

(g) 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.

II. Record-keeping

1. Feed business operators shall keep records relating to measures put in place to control hazards, in an appropriate man-
ner and for an appropriate period, 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. Feed business operators must, in particular, keep records on:

(a) any use of plant protection products and biocides;

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(b) use of genetically modified seeds;

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

(d) the results of any analyses carried out on samples taken from primary products or other samples taken for diag-

nostic purposes that have importance for feed safety;

(e) the source and quantity of each input of feed and the destination and quantity for each output of feed.

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 carry out on the farm.

PART B

Recommendations for guides to good practice

1. Where national and Community guides referred to in Chapter III of this Regulation are drawn up, they shall contain guid-

ance on good practices for the control of hazards in primary production of feed.

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

(a)

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

(b)

the use of water, organic waste and fertilisers;

(c)

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

(d)

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

(e)

the preparation, storage and traceability of feed materials;

(f)

the proper disposal of dead animals, waste and litter;

(g) protective measures to prevent the introduction of contagious diseases transmissible to animals through feed and

any obligation to notify the competent authority thereof;

(h) 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)

details relating to record-keeping.

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ANNEX II

REQUIREMENTS FOR FEED BUSINESSES OTHER THAN AT THE LEVEL OF
PRIMARY PRODUCTION OF FEED REFERRED TO IN ARTICLE 5(1)

FACILITIES AND EQUIPMENT

1. Feed processing and storage facilities, equipment, containers, crates, vehicles and their immediate surroundings shall be

kept clean, and effective pest control programmes shall be implemented.

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

(a)

permit adequate cleaning and/or disinfection;

(b) be such as to minimise the risk of error and to avoid 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 follow-
ing 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) 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 shall be tested for accuracy regularly.

(b) 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. Operators shall
demonstrate the effectiveness of mixers with regard to homogeneity.

4. Facilities must have adequate natural and/or artificial lighting.

5. Drainage facilities must be adequate for the purpose intended; they must be designed and constructed to avoid the risk

of contamination of feedingstuffs.

6. Water used in feed manufacture shall be of suitable quality for animals; the conduits for water shall be of an inert nature.

7. Sewage, waste and rainwater 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.

8. Windows and other openings must, where necessary, be proofed against pests. Doors must be close-fitting and proofed

against pests when closed.

9. Where necessary, ceilings and overhead fixtures must be designed, constructed and finished to prevent the accumula-
tion 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.

PERSONNEL

Feed businesses must have sufficient staff possessing the skills and qualifications necessary for the manufacture of the prod-
ucts concerned. An organisation chart setting out the qualifications (e.g. diplomas, professional experience) and responsi-
bilities of the supervisory staff must be drawn up and made available to the competent authorities responsible for inspec-
tion. 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.

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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.

4. The presence of prohibited feed undesirable substances and other contaminants in relation to human or animal health

shall be monitored, and appropriate control strategies to minimise the risk shall be put in place.

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

6. Feed business operators shall take adequate measures to ensure effective tracing of the products.

QUALITY CONTROL

1. Where appropriate, a qualified person responsible for quality control must be designated.

2. Feed businesses must, as part of a quality control system, have access to a laboratory with adequate staff and equipment.

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. Documentation relating to the raw materials used in final products must be kept by the manufacturer in order to ensure
traceability. Such documentation must be available to the competent authorities for a period appropriate for the use to
which the products are placed on the market. In addition, samples of ingredients and of each batch of products manu-
factured and 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 easy identification; they must be stored under conditions which prevent any abnormal change in
the composition of the sample or any adulteration. They must be kept at the disposal of the competent authorities for
a period appropriate to the use for which the feed is placed on the market. In the case of feedingstuffs for animals not
kept for food production, the manufacturer of the feedingstuff must only keep samples of the finished product.

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; 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 main-
tained in order to ensure good storage conditions, to which only persons authorised by the feed business operators have
access.

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3. Feeds shall be stored and transported in such a way as to be easily identifiable, in order to avoid any confusion or cross-

contamination and to prevent deterioration.

4. Containers and equipment used for the transport, storage, conveying, handling and weighing of feed shall be kept clean.

Cleaning programmes shall be introduced, and traces of detergents and disinfectants shall be minimised.

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

6. Where appropriate, temperatures shall be kept as low as possible to avoid condensation and spoilage.

RECORD-KEEPING

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

2. Feed business operators, except those who act solely as dealers without ever holding the product in their facilities, shall

keep in a register:

(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, in particular:

(i)

for feed additives:

— the nature and quantity of the additives produced, the respective dates of manufacture and, where appro-
priate, the number of the batch or of the specific portion of production, in the case of continuous
manufacture,

— the name and address of the establishment to which the additives were delivered, 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;

(ii)

for 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 farmers) 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, in the case of continuous
manufacture;

(iii)

for premixtures:

— the name and address of the manufacturers or suppliers of additives, the nature and quantity of the addi-
tives used and, where appropriate, the number of the batch or of the specific portion of production, in
the case of continuous manufacture,

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— 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.

(iv)

for compound feedingstuffs/feed materials:

— the name and address of additive/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 complementary feeds and the delivery

date,

— the type, quantity and formulation of the compound feed,

— the nature and quantity of feed materials or compound feedingstuffs manufactured, together with the date
of manufacture, and the name and address of the buyer (e.g. farmer, other feed business operators).

1. Feed business operators shall implement a system for registering and processing complaints.

COMPLAINTS AND PRODUCT RECALL

2. They shall put in place, where this proves necessary, a system for the prompt recall of products in the distribution net-
work. They shall define by means of written procedures the destination of any recalled products, and before such prod-
ucts are put back into circulation they must undergo a quality-control reassessment.

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ANNEX III

GOOD ANIMAL FEEDING PRACTICE

PASTURE GRAZING

The grazing of pastures and croplands shall be managed in a way that minimises the contamination of foods of animal ori-
gin by physical, biological or chemical hazards.

Where appropriate, an adequate rest period shall 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.

REQUIREMENTS FOR STABLE AND FEEDING EQUIPMENT

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

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

Buildings and feeding equipment shall be kept clean. Systems shall be put in place to regularly remove manure, waste mate-
rial and other possible sources of contamination of feed.

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

FEEDING

1. Storage

Feed shall be stored separately from chemicals and other products prohibited for animal feed. Storage areas and con-
tainers shall be kept clean and dry and appropriate pest-control measures implemented where necessary. Storage areas
and containers shall be cleaned regularly to avoid unnecessary cross-contamination.

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

Medicated feed and non-medicated feed intended for different categories or species of animals shall be stored such as to
reduce the risk of feeding to non-target animals.

2. Distribution

The on-farm feed distribution system shall ensure that the right feed is sent to the right destination. During distribution
and feeding, feed shall be handled in such a way as to ensure that contamination does not occur from contaminated
storage areas and equipment. Non-medicated feeds shall be handled separately from medicated feeds to prevent
contamination.

On-farm feed transport vehicles and feeding equipment shall be cleaned periodically, in particular when used to deliver
and distribute medicated feed.

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FEED AND WATER

Water for drinking or for acquaculture shall be of appropriate quality for the animals being produced. Where there is cause
for concern about contamination of animals or animal products from the water, measures shall be taken to evaluate and
minimise the hazards.

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

The person responsible for the feeding and handling of animals shall possess the requisite ability, knowledge and competence.

PERSONNEL

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ANNEX IV

CHAPTER 1

Additives authorised pursuant to Regulation (EC) No 1831/2003:

— Nutritional additives: all additives in the group,

— Zootechnical additives: all additives in the group,

— Technological additives: additives covered by Annex I(1)(b) (‘antioxidants’) of Regulation (EC) No 1831/2003: only

those with a fixed maximum content,

— Sensory additives: additives covered by Annex I(2)(a) (‘colorants’) of Regulation (EC) No 1831/2003: carotenoids and

xantophylls.

Products covered by Directive 82/471/EEC:

— 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

Additives authorised under Regulation (EC) No 1831/2003:

CHAPTER 2

— Zootechnical additives: additives covered by Annex I(4)(d)

(‘other zootechnical additives’) of Regulation (EC)

No 1831/2003

— Antibiotics: all additives,

— Coccidiostats and histomonostats: all additives,

— Growth promoters: all additives;

— Nutritional additives:

— additives covered by Annex I(3)(a) (Vitamins, provitamins and chemically well defined substances having a similar

effect) of Regulation (EC) No 1831/2003: A and D,

— additives covered by Annex I(3)(b) (‘compounds of trace elements’) of Regulation (EC) No 1831/2003: Cu and Se.

Additives authorised under Regulation (EC) No 1831/2003:

CHAPTER 3

Zootechnical additives: additives covered by Annex I(4)(d) (‘other zootechnical additives’) of Regulation (EC) No 1831/2003

— Antibiotics: all additives

— Coccidiostats and histomonostats: all additives,

— Growth promoters: all additives.

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ANNEX V

CHAPTER I

List of approved feed businesses

1

2

3

Identifying number

Activity

Name or business
name (1)

4

Address (2)

5

Remarks

(1) Name or business name of the feed businesses.
(2) Address of the feed businesses.

The identifying number must have the following structure:

CHAPTER II

1.

2.

3.

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 located;

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