Corrigendum to Regulation (EC) No 882/2004 of the European Parliament and of the Council 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 (OJ L 165, 30.4.2004)
Date: 2004-05-28
Institutions: Council of the European Union, European Parliament
Subjects: animal health, animal nutrition, animal welfare, approximation of laws, food inspection, foodstuff, health control

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CORRIGENDA

Corrigendum to Regulation (EC) No 882/2004 of the European Parliament and of the Council 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

(Official Journal of the European Union L 165 of 30 April 2004)

Regulation (EC) No 882/2004 should read as follows:

REGULATION (EC) No 882/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(3)

Having regard to the Treaty establishing the European Commu-
nity, and in particular Articles 37, 95 and 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),

Having regard to the opinion of the Committee of the Regions (2),

Acting in accordance with the procedure laid down in Article 251
of the Treaty (3),

Whereas:

(1)

(2)

Feed and food should be safe and wholesome. Community
legislation comprises a set of rules to ensure that this
objective is attained. These rules extend to the production
and the placing on the market of both feed and food.

The basic rules with regard to feed and food law are 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 lay-
ing down procedures in matters of food safety (4).

(1) OJ C 234, 30.9.2003, p. 25.
(2) OJ C 23, 27.1.2004, p. 14.
(3) Opinion of the European Parliament of 9 March 2004 (not yet pub-
lished in the Official Journal) and Council Decision of 26 April 2004.
(4) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Regulation

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

(4)

(5)

(6)

In addition to those basic rules, more specific feed and
food law covers different areas such as animal nutrition
including medicated feedingstuffs, feed and food hygiene,
zoonoses, animal by-products, residues and contaminants,
control and eradication of animal diseases with a public
health impact, feed and food labelling, pesticides, feed and
food additives, vitamins, mineral salts, trace elements and
other additives, materials in contact with food, quality and
compositional requirements, drinking water, ionisation,
novel foods and genetically modified organisms (GMOs).

Community feed and food law is based on the principle
that feed and food business operators at all stages of pro-
duction, processing and distribution within the businesses
under their control are responsible for ensuring that feed
and food satisfy the requirements of feed and food law
which are relevant to their activities.

Animal health and animal welfare are important factors
that contribute to the quality and safety of food, to the pre-
vention of the spreading of animal diseases and to a
humane treatment of animals. The rules covering these
matters are laid down in several acts. These acts specify the
obligations of natural and legal persons with regard to ani-
mal health and animal welfare as well as the duties of the
competent authorities.

The Member States should enforce feed and food law, ani-
mal heath and animal welfare rules and monitor and verify
that the relevant requirements thereof are fulfilled by busi-
ness operators at all stages of production, processing and
distribution. Official controls should be organised for that
purpose.

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(7)

(8)

(9)

It is therefore appropriate to establish at Community level
a harmonised framework of general rules for the organisa-
tion of such controls. It is appropriate to assess in the light
of experience whether such a general framework functions
properly, in particular in the area of animal health and wel-
fare. It is therefore appropriate for the Commission to
present a report together with any necessary proposal.

therefore not apply to these areas, all the more since the
objectives of this Regulation differ from the objectives pur-
sued by the control mechanisms for the common organi-
sation of the markets of agricultural products.

by

covered

adequately

As a general rule this Community framework should not
include official controls with regard to organisms harmful
to plants and plant products since these controls are
already
Council
Directive 2000/29/EC of 8 May 2000 on protective mea-
sures against the introduction into the Community of
organisms harmful to plants or plant products and against
their spread within the Community (1). Certain aspects of
this Regulation should however also apply to the plant
health sector and in particular those concerning the estab-
lishment of multiannual national control plans and Com-
munity inspections within the Member States and in third
countries.
to amend
is
Directive 2000/29/EC accordingly.

appropriate

therefore

It

Council Regulations (EEC) No 2092/91 of 24 June 1991
on organic production of agricultural products and indica-
tions referring thereto on agricultural products and food-
stuffs (2), (EEC) No 2081/92 of 14 July 1992 on the pro-
tection of geographical indications and designations of
origin for agricultural products and foodstuffs (3), and
(EEC) No 2082/92 of 14 July 1992 on certificates of spe-
cific character for agricultural products and foodstuffs (4)
contain specific measures for the verification of compli-
ance with the requirements contained therein. The require-
ments of this Regulation should be flexible enough so as to
take account of the specificity of these areas.

(11) The competent authorities for performing official controls
should meet a number of operational criteria so as to
ensure their impartiality and effectiveness. They should
have a sufficient number of suitably qualified and experi-
enced staff and possess adequate facilities and equipment
to carry out their duties properly.

(12) The official controls should be carried out using appropri-
ate techniques developed for that purpose, including rou-
tine surveillance checks and more intensive controls such
as inspections, verifications, audits, sampling and the test-
ing of samples. The correct implementation of those tech-
niques requires appropriate training of the staff perform-
ing official controls. Training is also required in order to
ensure that the competent authorities take decisions in a
uniform way, in particular with regard to the implementa-
tion of the hazard analysis and critical control points
(HACCP) principles.

(13)

The frequency of official controls should be regular and
proportionate to the risk, taking into account the results of
the checks carried out by feed and food business operators
under HACCP based control programmes or quality assur-
ance programmes, where such programmes are designed
to meet requirements of feed and food law, animal health
and animal welfare rules. Ad hoc controls should be car-
ried out in case of suspicion of non-compliance. Addition-
ally ad hoc controls could be carried out at any time, even
where there is no suspicion of non-compliance.

(10)

For the verification of compliance with the rules on the
common organisation of the markets of agricultural prod-
ucts (arable crops, wine, olive oil, fruit and vegetables,
hops, milk and milk products, beef and veal, sheepmeat
and goatmeat and honey) a well established and specific
control system is already in place. This Regulation should

(1) OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission

Directive 2004/31/EC (OJ L 85, 23.3.2004, p. 18).

(2) OJ L 198, 22.7.1991, p. 1. Regulation as last amended by Regulation

(EC) No 392/2004 (OJ L 65, 3.3.2004, p. 1).

(3) OJ L 208, 24.7.1992, p. 1. Regulation as last amended by Regula-

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

(4) OJ L 208, 24.7.1992, p. 9. Regulation as last amended by Regulation

(EC) No 806/2003.

(14) Official controls should take place on the basis of docu-
mented procedures so as to ensure that these controls are
carried out uniformly and are of a consistently high quality.

(15)

The competent authorities should ensure that where dif-
ferent control units are involved in carrying out official
controls, appropriate coordination procedures are in place
and effectively implemented.

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(16) The competent authorities should also ensure that, where
the competence to carry out official controls has been del-
egated from the central level to a regional or local level,
there is effective and efficient coordination between the
central level and that regional or local level.

(17)

Laboratories involved in the analysis of official samples
should work in accordance with internationally approved
procedures or criteria-based performance standards and
use methods of analysis that have, as far as possible, been
validated. Such laboratories should in particular have
equipment that enables the correct determination of stan-
dards such as maximum residue levels fixed by Commu-
nity law.

(18) The designation of Community and national reference
laboratories should contribute to a high quality and uni-
formity of analytical results. This objective can be achieved
by activities such as the application of validated analytical
methods, ensuring that reference materials are available,
the organisation of comparative testing and the training of
staff from laboratories.

(19) The activities of reference laboratories should cover all the
areas of feed and food law and animal health, in particular
those areas where there is a need for precise analytical and
diagnostic results.

(20)

For a number of activities related to official controls, the
European Committee for Standardisation (CEN) has devel-
oped European standards (EN standards) appropriate for
the purpose of this Regulation. These EN standards relate
in particular to the operation and assessment of testing
laboratories and to the operation and accreditation of con-
trol bodies. International standards have also been drawn
up by the International Organisation for Standardisation
(ISO) and the International Union of Pure and Applied
Chemistry (IUPAC). These standards might, in certain well
defined cases, be appropriate for the purposes of this Regu-
lation, taking into account that performance criteria are
laid down in feed and food law in order to ensure flexibil-
ity and cost effectiveness.

(21)

Provision should be made for delegating competence for
performing specific control tasks from the competent
authority to a control body, and for the conditions under
which such delegation can take place.

(22) Appropriate procedures should be available for the coop-
eration of the competent authorities in and between the
Member States, in particular when official controls reveal
that feed and food problems extend to more than one
Member State. In order to facilitate such cooperation,
Member States should designate one or more liaison bod-
ies with the role of coordinating the transmission and
reception of requests for assistance.

(23)

In accordance with Article 50 of Regulation (EC)
No 178/2002, the Member States shall inform the Com-
mission where information relating to the existence of a
serious direct or indirect risk to human health deriving
from food or feed is available.

(24)

It is important to create uniform procedures for the con-
trol of feed and food from third countries introduced into
the territory of the Community, taking into account that
harmonised import procedures have already been estab-
lished for food of animal origin by virtue of Council
Directive 97/78/EC (1), and for live animals by virtue of
Council Directive 91/496/EEC (2).

These existing procedures function properly and should be
maintained.

(25) The checks on feed and food from third countries referred
to in Directive 97/78/EC are limited to veterinary aspects.
It is necessary to supplement these checks with official
controls on aspects that are not covered by veterinary
checks, such as those on additives, labelling, traceability,
irradiation of food and materials in contact with food.

(26) Community legislation also provides for procedures for the
virtue of Council
control of
imported feed by
Directive 95/53/EC of 25 October 1995 fixing the prin-
ciples governing the organisation of official inspections in
the field of animal nutrition (3). That Directive contains
principles and procedures that must be applied by the
Member States when releasing imported feed for free
circulation.

(1) Council Directive 97/78/EC of 18 December 1997 laying down the
principles governing the organisation of veterinary checks on prod-
ucts entering the Community from third countries (OJ L 24,
30.1.1998, p. 9).

(2) Council Directive 91/496/EEC of 15 July 1991 laying down the prin-
ciples governing the organisation of veterinary checks on animals
entering the Community from third countries (OJ L 268, 24.9.1991,
p. 56). Directive as last amended by Directive 96/43/EC (OJ L 162,
1.7.1996, p. 1).

(3) OJ L 265, 8.11.1995, p. 17. Directive as last amended by
Directive 2001/46/EC of the European Parliament and of the Coun-
cil (OJ L 234, 1.9.2001, p. 55).

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(27)

(28)

(29)

(30)

(31)

It is appropriate to establish Community rules in order to
ensure that feed and food from third countries is submit-
ted to official controls before release for free circulation in
the Community. Special attention should be paid to import
controls of feed and food for which there may be an
increased risk of contamination.

Provision should also be made for the organisation of offi-
cial controls of feed and food that is introduced into the
territory of the Community under customs procedures
other than free circulation, and in particular those intro-
duced under the customs procedures referred to in points
(b) to (f) of Article 4(16) of Council Regulation (EEC)
No 2913/92 of 12 October 1992 establishing the Com-
munity Customs Code (1), as well as their entry into a free
zone or free warehouse. This includes the introduction of
feed and food from third countries by passengers of inter-
national means of transport and through parcels sent by
mail.

For the purpose of official controls on feed and food, it is
necessary to define the territory of the Community in
which the rules apply in order to ensure that feed and food
that is introduced into this territory is submitted to the
controls laid down by this Regulation. This territory is not
necessarily the same as provided for in Article 299 of the
Treaty, or as defined in Article 3 of Regulation (EEC)
No 2913/92.

In order to ensure a more efficient organisation of the offi-
cial controls on feed and food from third countries and in
order to facilitate commercial flows, it may be necessary to
designate specific points of entry for feed and food from
third countries into the territory of the Community. Like-
wise, it may be necessary to require prior notification of
the arrival of goods at the territory of the Community. It
should be ensured that each designated point of entry has
access to the appropriate facilities to operate controls
within reasonable time limits.

In establishing rules on the official controls of feed and
food from third countries, it should be ensured that the
competent authorities and the customs services work
together, taking into account the fact that rules to that
effect already exist in Council Regulation (EEC) No 339/93
of 8 February 1993 on checks for conformity with the
rules on product safety in the case of products imported
from third countries (2).

of the Member States should be able to levy the fees or
charges to cover the costs incurred through official con-
trols. In the process, the competent authorities of the
Member States will be at liberty to establish the fees and
charges as flat-rate amounts based on the costs incurred
and taking the specific situation of the establishments into
account. Where fees are imposed on operators, common
principles should apply. It is appropriate therefore to lay
down the criteria for setting the level of inspection fees.
With regard to fees applicable for import controls, it is
appropriate to establish directly the rates for main import
items with a view to ensuring their uniform application
and to avoiding trade distortions.

(33) Community feed and food law provides for the registration
or approval of certain feed and food businesses by the
competent authority. This is particularly the case in Regu-
lation (EC) No 852/2004 of the European Parliament and
of the Council of 29 April 2004 on the hygiene of food-
stuffs (3), Regulation (EC) No 853/2004 of the European
Parliament and of the Council of 29 April 2004 laying
down specific hygiene rules for food of animal origin (3),
Council Directive 95/69/EC of 22 December 1995 laying
down the conditions and arrangements for approving and
registering certain establishments and intermediaries oper-
ating in the animal feed sector (4) and the future regulation
on feed hygiene.

Procedures should be put in place in order to ensure that
registration and approval of feed and food businesses are
carried out in an effective and transparent way.

(34)

In order to have a global and uniform approach with
regard to official controls, Member States should establish
and implement multiannual national control plans in
accordance with broad guidelines drawn up at Community
level. These guidelines should promote coherent national
strategies, and identify risk-based priorities and the most
effective control procedures. A Community strategy should
take a comprehensive, integrated approach to the opera-
tion of controls. In view of the non-binding character of
certain technical guidelines to be established it is appropri-
ate to establish them by means of a consultative Commit-
tee procedure.

(32) Adequate financial resources should be available for orga-
nising official controls. Hence, the competent authorities

(35) The multiannual national control plans should cover feed
and food law, and the legislation on animal health and ani-
mal welfare.

(1) OJ L 302, 19.10.1992, p. 1. Regulation as last amended by Regula-
tion (EC) No 2700/2000 of the European Parliament and of the
Council (OJ L 311, 12.12.2000, p. 17).

(2) OJ L 40, 17.2.1993, p. 1. Regulation as last amended by Regulation

(EC) No 806/2003.

(3) OJ L 139, 30.4.2004, p.55.
(4) OJ L 332, 30.12.1995, p. 15. Directive as last amended by Regula-

tion (EC) No 806/2003.

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(36) The multiannual national control plans should establish a
solid basis for the Commission inspection services to carry
out controls in the Member States. The control plans
should enable the Commission inspection services to verify
whether the official controls in the Member States are
organised in accordance with the criteria laid down in this
Regulation. Where appropriate and, in particular, where
the audit of the Member States against the multiannual
national control plans shows weaknesses or failures,
detailed inspections and audits should be carried out.

should therefore be subject to effective, dissuasive and pro-
portionate measures at national
level throughout the
Community.

(42)

Such measures should include administrative action by the
competent authorities in the Member States who should
have procedures in place for that purpose. The advantage
of such procedures is that quick action can be undertaken
in order to restore the situation.

(37) Member States should be required to present an annual
report to the Commission with information on the imple-
mentation of the multiannual national control plans. This
report should provide the results of the official controls
and audits carried out during the previous year and, where
necessary, an update of the initial control plan in response
to these results.

(43) Operators should have a right to appeal against the deci-
sions taken by the competent authority as a result of the
official controls, and be informed of such a right.

(38) Community controls in the Member States should allow
the Commission control services to verify whether feed
and food law and the legislation on animal health and ani-
mal welfare are implemented in a uniform and correct way
throughout the Community.

(44)

It is appropriate to take account of the special needs of
developing countries, and in particular of
the least-
developed countries, and to introduce measures to that
effect. The Commission should be committed to support
developing countries with regard to feed and food safety,
which is an important element of human health and trade
development. Such support should be organised in the
context of the Community’s development cooperation
policy.

(39) Community controls in third countries are required in
order to verify compliance or equivalence with Commu-
nity feed and food law as well as with the legislation on
animal health and, where appropriate, welfare. Third coun-
tries may also be requested to provide information on their
control systems. This information, which should be estab-
lished on the basis of Community guidelines, should form
the basis for subsequent Commission controls, which
should be carried out within a multidisciplinary framework
covering the main sectors exporting to the Community.
This evolution should allow a simplification of the current
regime, enhance effective control cooperation, and conse-
quently facilitate trade flows.

(45) The rules contained in this Regulation underpin the inte-
grated and horizontal approach necessary to implement a
coherent control policy on feed and food safety, animal
health and animal welfare. There should be room however
to develop specific control rules where required,
for
example with regard to the setting of maximum residue
levels for certain contaminants at Community level. Like-
wise, more specific rules existing in the area of feed and
food and animal health and animal welfare controls should
be kept in place.

(40)

In order to ensure that imported goods comply with or are
equivalent to Community feed and food law, it is necessary
to establish procedures that allow the definition of import
conditions and certification requirements as appropriate.

include

in particular

acts:
These
Directive
96/22/EC
of 29 April 1996 concerning the prohibition on
the use in (1), Directive 96/23/EC (2), Regulation (EC)

Council Directive

96/22/EC

following

the

(41)

Breaches of feed and food law and of animal health and
animal welfare rules may constitute a threat to human
health, animal health, and animal welfare. Such breaches

(1)

stockfarming of certain substances having a hormonal or thyrostatic
action and of beta-agonists, (OJ L 125, 23.5.1996, p. 3). Directive as
last amended by Directive 2003/74/EC of the European Parliament
and of the Council (OJ L 262, 14.10.2003, p. 17).

(2) Council Directive 96/23/EC of 29 April 1996 on measures to moni-
tor certain substances and residues thereof in live animals and ani-
mal products (OJ L 125, 23.5.1996, p. 10). Directive as last amended
by Regulation (EC) No 806/2003.

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No 854/2004 (1), Regulation (EC) No 999/2001 (2), Regu-
lation (EC) No 2160/2003 (3), Directive 86/362/EEC (4),
Directive 90/642/EEC (5) and the implementing rules
resulting
92/1/EEC (6),
Directive 92/2/EEC (7), and acts on the control of ani-
mal diseases such as foot-and-mouth disease, swine fever
etc., as well as requirements on the official controls on the
welfare of animals.

therefrom,

Directive

(46)

This Regulation covers areas that are already covered in
certain acts in force at present. It is appropriate therefore
to repeal in particular the following acts on feed and food
controls and to replace them by the rules of this Regula-
tion: Directive 70/373/EEC (8); Directive 85/591/EEC (9);
Directive 89/397/EEC (10); Directive 93/99/EEC (11);
Decision 93/383/EEC (12); Directive 95/53/EC; Directive

(1) Regulation (EC) No 854/2004 of the European Parliament and of the
Council of 29 April 2004 laying down specific rules for the organi-
sation of official controls on products of animal origin intended for
human consumption (OJ L 139, 30.4.2004, p. 206).

(2) Regulation (EC) No 999/2001 of the European Parliament and of the
Council of 22 May 2001 laying down rules for the prevention, con-
trol and eradication of certain transmissible spongiform encephalo-
pathies (OJ L 147, 31.5.2001, p. 1). Regulation as last amended by
Commission Regulation (EC) No 2245/2003 (OJ L 333, 20.12.2003,
p. 28).

(3) Regulation (EC) No 2160/2003 of the European Parliament and of
the Council of 17 November 2003 on the control of salmonella and
other food-borne zoonotic agents (OJ L 325, 12.12.2003, p. 1).
(4) Council Directive 86/362/EEC of 24 July 1986 on the fixing of maxi-
mum levels for pesticide residues in and on cereals (OJ L 221,
7.8.1986, p. 37). Directive as last amended by Commission
Directive 2004/2/EC (OJ L 14, 21.1.2004, p. 10).

(5) Council Directive 90/642/EEC of 27 November 1990 on the fixing
of maximum levels for pesticide residues in and on certain products
of plant origin, including fruit and vegetables (OJ L 350, 14.12.1990,
p. 71).
Commission
Directive 2004/2/EC.

amended

Directive

last

by

as

(6) Commission Directive 92/1/EEC of 13 January 1992 on the moni-
toring of temperatures in the means of transport, warehousing and
storage of quick-frozen foodstuffs intended for human consumption
(OJ L 34, 11.2.1992, p. 28).

(7) Commission Directive 92/2/EEC of 13 January 1992 laying down the
sampling procedure and the Community method of analysis for the
official control of the temperatures of quick-frozen foods intended
for human consumption (OJ L 34, 11.2.1992, p. 30).

(8) Council Directive 70/373/EEC of 20 July 1970 on the introduction
of Community methods of sampling and analysis for the official con-
trol of feedingstuffs (OJ L 170, 3.8.1970, p. 2). Directive as last
amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003,
p. 36).

(9) Council Directive 85/591/EEC of 20 December 1985 concerning the
introduction of Community methods of sampling and analysis for
the monitoring of foodstuffs intended for human consumption (OJ
L 372, 31.12.1985, p. 50). Directive as last amended by Regula-
tion (EC) No 1882/2003 of the European Parliament and of the
Council (OJ L 284, 31.10.2003, p. 1)

(10) Council Directive 89/397/EEC of 14 June 1989 on the official con-

trol of foodstuffs (OJ L 186, 30.6.1989, p. 23)

(11) Council Directive 93/99/EEC of 29 October 1993 on the subject of
additional measures concerning the official control of foodstuffs (OJ
L 290, 24.11.1993, p. 14). Directive as amended by Regulation (EC)
No 1882/2003.

(12) Council Decision 93/383/EEC of 14 June 1993 of reference labora-
tories for the monitoring of marine biotoxins (OJ L 166, 8.7.1993,
p. 31). Decision as amended by Decision 1999/312/EC (OJ L 120,
8.5.1999, p. 37).

96/43/EC (13); Decision 98/728/EC (14); and Decision
1999/313/EC (15).

(47)

In the light of
97/78/EC and 2000/29/EC should be amended.

this Regulation, Directives 96/23/EC,

(48)

Since the objective of this Regulation, namely to ensure a
harmonised approach with regard to official controls, can-
not be sufficiently achieved by the Member States and can
therefore, by reason of its complexity, its trans-border
character and, with regard to feed and food imports, its
international character, be better achieved at Community
level, the Community may adopt measures, in accordance
with the principle of subsidiarity as set out in Article 5 of
the Treaty. In accordance with the principle of proportion-
ality, as set out in that Article, this Regulation does not go
beyond what is necessary in order to achieve that objective.

(49) 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 (16),

HAVE ADOPTED THIS REGULATION:

TITLE I

SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1

Subject matter and scope

1.
This Regulation lays down general rules for the performance
of official controls to verify compliance with rules aiming, in par-
ticular, at:

(a) preventing, eliminating or reducing to acceptable levels risks
to humans and animals, either directly or through the
environment;

and

(13) Council Directive 96/43/EC of 26 June 1996 amending and consoli-
dating Directive 85/73/EEC in order to ensure financing of veterinary
inspections and controls on live animals and certain animal products
(OJ L 162, 1.7.1996, p. 1).

(14) Council Decision 98/728/EC of 14 December 1998 concerning a
Community system for fees in the animal feed sector (OJ L 346,
22.12.1998, p. 51).

(15) Council Decision 1999/313/EC of 29 April 1999 on reference labo-
ratories for monitoring bacteriological and viral contamination of
bivalve molluscs (OJ L 120, 8.5.1999, p. 40).

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

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(b) guaranteeing fair practices in feed and food trade and pro-
tecting consumer interests, including feed and food labelling
and other forms of consumer information.

4.

‘competent authority’ means the central authority of a Mem-
ber State competent for the organisation of official controls
or any other authority to which that competence has been
conferred; it shall also include, where appropriate, the corre-
sponding authority of a third country;

2.
This Regulation shall not apply to official controls for the
verification of compliance with the rules on common market
organisations of agricultural products.

This Regulation shall be without prejudice to specific Com-

3.
munity provisions concerning official controls.

4.
The performance of official controls pursuant to this Regu-
lation shall be without prejudice to feed and food business opera-
tors’ primary legal responsibility for ensuring feed and food safety,
as laid down in Regulation (EC) No 178/2002, and any civil or
criminal liability arising from the breach of their obligations.

5.

‘control body’ means an independent third party to which the
competent authority has delegated certain control tasks;

6.

‘audit’ means a systematic and independent examination to
determine whether activities and related results comply with
planned arrangements and whether these arrangements are
implemented effectively and are
to achieve
objectives;

suitable

Article 2

Definitions

7.

‘inspection’ means the examination of any aspect of feed,
food, animal health and animal welfare in order to verify that
such aspect(s) comply with the legal requirements of feed and
food law and animal health and animal welfare rules;

For the purposes of this Regulation, the definitions laid down in
Articles 2 and 3 of Regulation (EC) No 178/2002 shall apply.

8.

‘monitoring’ means conducting a planned sequence of obser-
vations or measurements with a view to obtaining an over-
view of the state of compliance with feed or food law, ani-
mal health and animal welfare rules;

The following definitions shall also apply:

1.

‘official control’ means any form of control that the compe-
tent authority or the Community performs for the verifica-
tion of compliance with feed and food law, animal health and
animal welfare rules;

9.

‘surveillance’ means a careful observation of one or more feed
or food businesses, feed or food business operators or their
activities;

2.

‘verification’ means checking, by examination and the con-
sideration of objective evidence, whether specified require-
ments have been fulfilled;

10.

‘non-compliance’ means non-compliance with feed or food
law, and with the rules for the protection of animal health
and welfare;

3.

‘feed law’ means the laws, regulations and administrative pro-
visions governing feed in general and feed safety in particu-
lar, whether at Community or national level; it covers all
stages of production, processing and distribution of feed and
the use of feed;

11.

‘sampling for analysis’ means taking feed or food or any other
substance (including from the environment) relevant to the
production, processing and distribution of feed or food or to
the health of animals, in order to verify through analysis
compliance with feed or food law or animal health rules;

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12.

‘official certification’ means the procedure by which the com-
petent authority or control bodies, authorised to act in such
a capacity, provide written, electronic or equivalent assurance
concerning compliance;

20.

‘control plan’ means a description established by the compe-
tent authority containing general information on the struc-
ture and organisation of its official control systems.

13.

‘official detention’ means the procedure by which the com-
petent authority ensures that feed or food is not moved or
tampered with pending a decision on its destination;
it
includes storage by feed and food business operators in
accordance with instructions from the competent authority;

TITLE II

OFFICIAL CONTROLS BY MEMBER STATES

14.

‘equivalence’ means the capability of different systems or
measures to meet the same objectives; and ‘equivalent’ means
different systems or measures capable of meeting the same
objectives;

15.

‘import’ means the release for free circulation of feed or food
or the intention to release feed or food for free circulation
within the meaning of Article 79 of Regulation (EEC)
No 2913/92 in one of the territories referred to in Annex I;

16.

‘introduction’ means import as defined in point 15 above,
and the placing of goods under the customs procedures
referred to in points (b) to (f) of Article 4(16) of Regulation
(EEC) No 2913/92, as well as their entry into a free zone or
free warehouse;

CHAPTER I

GENERAL OBLIGATIONS

Article 3

General obligations with regard to the organisation of
official controls

1. Member States shall ensure that official controls are carried
out regularly, on a risk basis and with appropriate frequency, so
as to achieve the objectives of this Regulation taking account of:

(a)

identified risks associated with animals, feed or food, feed or
food businesses, the use of feed or food or any process, mate-
rial, substance, activity or operation that may influence feed
or food safety, animal health or animal welfare;

17.

‘documentary check’ means the examination of commercial
documents and, where appropriate, of documents required
under
food law that are accompanying the
consignment;

feed or

(b)

feed or food business operators’ past record as regards com-
pliance with feed or food law or with animal health and ani-
mal welfare rules;

18.

‘identity check’ means a visual inspection to ensure that cer-
tificates or other documents accompanying the consignment
tally with the labelling and the content of the consignment;

(c)

the reliability of any own checks that have already been car-
ried out;

19.

‘physical check’ means a check on the feed or food itself
which may include checks on the means of transport, on the
packaging, labelling and temperature, the sampling for analy-
sis and laboratory testing and any other check necessary to
verify compliance with feed or food law;

(d) any information that might indicate non-compliance.

and

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Official controls shall be carried out without prior warning,
2.
except in cases such as audits where prior notification of the feed
or food business operator is necessary. Official controls may also
be carried out on an ad hoc basis.

2.

The competent authorities shall ensure:

3.
Official controls shall be carried out at any of the stages of
production, processing and distribution of feed or food and of
animals and animal products. They shall include controls on feed
and food businesses, on the use of feed and food, on the storage
of feed and food, on any process, material, substance, activity or
operation including transport applied to feed or food and on live
animals, required to achieve the objectives of this Regulation.

4.
Official controls shall be applied, with the same care, to
exports outside the Community, to the placing on the market
within the Community and to introductions from third countries
into the territories referred to in Annex I.

5. Member States shall take all necessary measures to ensure
that products intended for dispatch to another Member State are
controlled with the same care as those intended to be placed on
the market in their own territory.

The competent authority of the Member State of destination
6.
may check compliance of feed and food with feed and food law
by means of non-discriminatory checks. To the extent strictly nec-
essary for the organisation of the official controls, Member States
may ask operators who have goods delivered to them from
another Member State to report the arrival of such goods.

If, during a check carried out at the place of destination or
7.
during storage or transport, a Member State establishes non-
compliance, it shall take the appropriate measures, which may
include re-dispatch to the Member State of origin.

CHAPTER II

COMPETENT AUTHORITIES

Article 4

Designation of competent authorities and operational
criteria

(a)

the effectiveness and appropriateness of official controls on
live animals, feed and food at all stages of production, pro-
cessing and distribution, and on the use of feed;

(b)

that staff carrying out official controls are free from any con-
flict of interest;

(c)

that they have, or have access to, an adequate laboratory
capacity for testing and a sufficient number of suitably quali-
fied and experienced staff so that official controls and con-
trol duties can be carried out efficiently and effectively;

(d)

that they have appropriate and properly maintained facilities
and equipment to ensure that staff can perform official con-
trols efficiently and effectively;

(e)

that they have the legal powers to carry out official controls
and to take the measures provided for in this Regulation;

(f)

that they have contingency plans in place, and are prepared
to operate such plans in the event of an emergency;

(g)

that the feed and food business operators are obliged to
undergo any inspection carried out in accordance with this
Regulation and to assist staff of the competent authority in
the accomplishment of their tasks.

1. Member States shall designate the competent authorities
responsible for the purposes and official controls set out in this
Regulation.

3. When a Member State confers the competence to carry out
official controls on an authority or authorities other than a cen-
tral competent authority, in particular those at regional or local
level, efficient and effective coordination shall be ensured between
all the competent authorities involved, including where appropri-
ate in the field of environmental and health protection.

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Competent authorities shall ensure the impartiality, quality
4.
and consistency of official controls at all levels. The criteria listed
in paragraph 2 must be fully respected by every authority on
which the competence to carry out official controls is conferred.

(b)

there is proof that the control body:

5. When, within a competent authority, more than one unit is
competent to carry out official controls, efficient and effective
coordination and cooperation shall be ensured between the dif-
ferent units.

(i) has the expertise, equipment and infrastructure required

to carry out the tasks delegated to it;

(ii) has a sufficient number of suitably qualified and experi-

enced staff;

6.
Competent authorities shall carry out internal audits or may
have external audits carried out, and shall take appropriate mea-
sures in the light of their results, to ensure that they are achieving
the objectives of this Regulation. These audits shall be subject to
independent scrutiny and shall be carried out in a transparent
manner.

and

7.
Detailed rules for the implementation of this Article may be
adopted in accordance with the procedure referred to in
Article 62(3).

Article 5

Delegation of specific tasks related to official controls

(iii) is impartial and free from any conflict of interest as

regards the exercise of the tasks delegated to it;

(c)

the control body works and is accredited in accordance with
European Standard EN 45004 ‘General criteria for the opera-
tion of various types of bodies performing inspection’ and/or
another standard if more relevant to the delegated tasks in
question;

1.
The competent authority may delegate specific tasks related
to official controls to one or more control bodies in accordance
with paragraphs 2 to 4.

(d)

laboratories operate in accordance with the standards
referred to in Article 12(2);

A list of tasks that may or may not be delegated may be estab-
lished in accordance with the procedure referred to in
Article 62(3).

(e)

the control body communicates the results of the controls
carried out to the competent authority on a regular basis and
whenever the competent authority so requests. If the results
of the controls indicate non-compliance or point to the like-
lihood of non-compliance, the control body shall immedi-
ately inform the competent authority;

However, the activities referred to in Article 54 shall not be the
subject of such a delegation.

(f)

there is efficient and effective coordination between the del-
egating competent authority and the control body.

The competent authority may delegate specific tasks to a

2.
particular control body only if:

(a)

there is an accurate description of the tasks that the control
body may carry out and of the conditions under which it
may carry them out;

Competent authorities delegating specific tasks to control
3.
bodies shall organise audits or inspections of control bodies as
necessary. If, as a result of an audit or an inspection, it appears
that such bodies are failing to carry out properly the tasks del-
egated to them, the delegating competent authority may with-
draw the delegation. It shall withdraw it without delay if the con-
trol body fails to take appropriate and timely remedial action.

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Any Member State wishing to delegate a specific control
4.
task to a control body shall notify the Commission. This notifi-
cation shall provide a detailed description of:

and

(a)

the competent authority that would delegate the task;

(b)

information pursuant to Article 10 of Regulation (EC)
No 178/2002.

(b)

the task that it would delegate;

and

(c)

the control body to which it would delegate the task.

Article 6

Staff performing official controls

The competent authority shall ensure that all of its staff perform-
ing official controls:

The competent authority shall take steps to ensure that
2.
members of their staff are required not to disclose information
acquired when undertaking their official control duties which by
its nature is covered by professional secrecy in duly justified cases.
Protection of professional secrecy shall not prevent the dissemi-
nation by the competent authorities of information referred to in
paragraph 1(b). The rules of Directive 95/46/EC of the European
Parliament and of the Council of 24 October 1995 on the pro-
tection of individuals with regard to the processing of personal
data and on the free movement of such data (1) remain unaffected.

Information covered by professional secrecy includes in

3.
particular:

— the confidentiality of preliminary investigation proceedings

or of current legal proceedings,

(a)

receive, for their area of competence, appropriate training
enabling them to undertake their duties competently and to
carry out official controls in a consistent manner. This train-
ing shall cover as appropriate the areas referred to in Annex II,
Chapter I;

— personal data,

(b) keep up to date in their area of competence and receive regu-

lar additional training as necessary;

— the documents covered by an exception in Regulation (EC)
No 1049/2001 of the European Parliament and of the Coun-
cil of 30 May 2001 regarding public access to European Par-
liament, Council and Commission documents (2),

and

(c) have aptitude for multidisciplinary cooperation.

Article 7

Transparency and confidentiality

— information protected by national and Community legisla-
tion concerning in particular professional secrecy, the confi-
dentiality of deliberations,
relations and
national defence.

international

Article 8

Control and verification procedures

1.
The competent authorities shall ensure that they carry out
their activities with a high level of transparency. For that purpose,
relevant information held by them shall be made available to the
public as soon as possible.

In general, the public shall have access to:

1.
Competent authorities shall carry out official controls in
accordance with documented procedures. These procedures shall
contain information and instructions for staff performing official
controls including, inter alia, the areas referred to in Annex II,
Chapter II.

(a)

information on the control activities of the competent
authorities and their effectiveness;

(EC) No 1882/2003.

(2) OJ L 145, 31.5.2001, p. 43.

(1) OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation

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2. Member States shall ensure that they have legal procedures
in place in order to ensure that staff of the competent authorities
have access to premises of and documentation kept by feed and
food business operators so as to be able to accomplish their tasks
properly.

3.

Competent authorities shall have procedures in place:

(a)

to verify the effectiveness of official controls that they carry
out;

and

(b)

to ensure that corrective action is taken when needed and
that the documentation referred to in paragraph 1 is updated
as appropriate.

4.
The Commission may establish guidelines for official con-
trols in accordance with the procedure referred to in Article 62(2).

The guidelines may, in particular, contain recommendations con-
cerning official controls on:

(a)

the implementation of HACCP principles;

(b) management systems that feed or food business operators
operate with a view to meeting the requirements of feed or
food law;

(c)

the microbiological, physical and chemical safety of feed and
food.

Article 9

Reports

Article 10

Control activities, methods and techniques

1.
Tasks related to official controls shall, in general, be carried
out using appropriate control methods and techniques such as
monitoring, surveillance, verification, audit, inspection, sampling
and analysis.

Official controls on feed and food shall include, inter alia, the

2.
following activities:

(a)

examination of any control systems that feed and food busi-
ness operators have put in place and the results obtained;

(b)

inspection of:

(i) primary producers’ installations, feed and food busi-
nesses, including their surroundings, premises, offices,
equipment, installations and machinery, transport, as
well as of feed and food;

(ii)

raw materials, ingredients, processing aids and other
products used for the preparation and production of
feed and food;

(iii) semi-finished products;

(iv) materials and articles intended to come into contact with

food;

(v) cleaning and maintenance products and processes, and

pesticides;

The competent authority shall draw up reports on the offi-

1.
cial controls that it has carried out.

(vi)

labelling, presentation and advertising;

2.
These reports shall include a description of the purpose of
the official controls, the control methods applied, the results of
the official controls and, where appropriate, action that the busi-
ness operator concerned is to take.

(c)

checks on the hygiene conditions in feed and food businesses;

3.
The competent authority shall provide the business opera-
tor concerned with a copy of the report referred to in paragraph 2,
at least in case of non-compliance.

(d) assessment of procedures on good manufacturing practices
(GMP), good hygiene practices (GHP), good farming practices
and HACCP, taking into account the use of guides established
in accordance with Community legislation;

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(e)

examination of written material and other records which may
be relevant to the assessment of compliance with feed or
food law;

2. Where paragraph 1 does not apply, validation of methods
of analysis may take place within a single laboratory according to
an internationally accepted protocol.

(f)

interviews with feed and food business operators and with
their staff;

3. Wherever possible, methods of analysis shall be character-
ised by the appropriate criteria set out in Annex III.

(g)

the reading of values recorded by feed or food business mea-
suring instruments;

The following implementing measures may be taken in

4.
accordance with the procedure referred to in Article 62(3):

(h) controls carried out with the competent authority’s own
instruments to verify measurements taken by feed and food
business operators;

(a) methods of sampling and analysis, including the confirma-
tory or reference methods to be used in the event of a dispute;

(b) performance criteria, analysis parameters, measurement
uncertainty and procedures for the validation of the meth-
ods referred to in (a);

(i)

any other activity required to ensure that the objectives of
this Regulation are met.

and

CHAPTER III

SAMPLING AND ANALYSIS

(c)

rules on the interpretation of results.

Article 11

Methods of sampling and analysis

5.
The competent authorities shall establish adequate proce-
dures in order to guarantee the right of feed and food business
operators whose products are subject to sampling and analysis to
apply for a supplementary expert opinion, without prejudice to
the obligation of competent authorities to take prompt action in
case of emergency.

Sampling and analysis methods used in the context of offi-

1.
cial controls shall comply with relevant Community rules or,

6.
In particular, they shall ensure that feed and food business
operators can obtain sufficient numbers of samples for a supple-
mentary expert opinion, unless impossible in case of highly per-
ishable products or very low quantity of available substrate.

(a)

if no such rules exist, with internationally recognised rules or
protocols, for example those that the European Committee
for Standardisation (CEN) has accepted or those agreed in
national legislation;

Samples must be handled and labelled in such a way as to

7.
guarantee both their legal and analytical validity.

or,

Article 12

Official laboratories

(b)

in the absence of the above, with other methods fit for the
intended purpose or developed in accordance with scientific
protocols.

1.
The competent authority shall designate laboratories that
may carry out the analysis of samples taken during official
controls.

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However, competent authorities may only designate labo-
2.
ratories that operate and are assessed and accredited in accor-
dance with the following European standards:

3. Member States shall review these contingency plans as
appropriate, particularly in the light of changes in the organisa-
tion of the competent authority and of experience, including expe-
rience gained from simulation exercises.

(a) EN ISO/IEC 17025 on ‘General requirements for the compe-

tence of testing and calibration laboratories’;

(b) EN 45002 on ‘General criteria for the assessment of testing

laboratories’;

(c) EN 45003 on ‘Calibration and testing laboratory accredita-
tion system — General requirements for operation and
recognition’,

4. Where necessary, implementing measures may be adopted
in accordance with the procedure referred to in Article 62(3).
Such measures shall establish harmonised rules for contingency
plans to the extent necessary to ensure that such plans are com-
patible with the general plan for crisis management referred to in
Article 55 of Regulation (EC) No 178/2002. They shall also indi-
cate the role of stakeholders in the establishment and operation
of contingency plans.

taking into account criteria for different testing methods laid
down in Community feed and food law.

CHAPTER V

The accreditation and assessment of testing laboratories
3.
referred to in paragraph 2 may relate to individual tests or groups
of tests.

The competent authority may cancel

the designation
4.
referred to in paragraph 1 when the conditions referred to in
paragraph 2 are no longer fulfilled.

CHAPTER IV

CRISIS MANAGEMENT

Article 13

Contingency plans for feed and food

For the implementation of the general plan for crisis man-
1.
agement
referred to in Article 55 of Regulation (EC)
No 178/2002, Member States shall draw up operational contin-
gency plans setting out measures to be implemented without
delay when feed or food is found to pose a serious risk to humans
or animals either directly or through the environment.

2.

These contingency plans shall specify:

(a)

the administrative authorities to be engaged;

(b)

their powers and responsibilities;

and

OFFICIAL CONTROLS ON THE INTRODUCTION OF FEED AND
FOOD FROM THIRD COUNTRIES

Article 14

Official controls on feed and food of animal origin

This Regulation shall not affect the requirements for veteri-
1.
nary checks on feed and food of animal origin provided for in
Directive 97/78/EC. However, the competent authority desig-
nated in accordance with Directive 97/78/EC shall, in addition,
carry out official controls to verify compliance with aspects of
feed or food law that that Directive does not cover, as appropri-
ate, including those aspects referred to in Title VI, Chapter II of
this Regulation.

2.
The general rules of Articles 18 to 25 of this Regulation
shall also apply to official controls on all feed and food, including
feed and food of animal origin.

3.

Satisfactory results of checks on goods that are:

(a) placed under one of the customs procedures referred to in
to (f) of Article 4(16) of Regulation (EEC)

points (b)
No 2913/92;

or

(c)

channels and procedures for sharing information between
the relevant parties.

(b)

to be handled in free zones or free warehouses, as defined in
Article 4(15)(b) of Regulation (EEC) No 2913/92,

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shall neither affect the duty of feed and food business opera-
tors to ensure that feed and food comply with feed and food
law from the moment of release for free circulation nor pre-
vent further official controls on the feed or food concerned
from being carried out.

Article 15

Official controls on feed and food of non-animal origin

1.
The competent authority shall carry out regular official con-
trols on feed and food of non-animal origin not included in the
scope of Directive 97/78/EC, imported into the territories referred
to in Annex I. It shall organise these controls on the basis of the
multi-annual national control plan drawn up in accordance with
Articles 41 to 43 and in the light of potential risks. The controls
shall cover all aspects of feed and food law.

These controls shall be carried out at an appropriate place,
2.
including the point of entry of the goods into one of the territo-
ries referred to in Annex I, the point of release for free circula-
tion, warehouses, the premises of the importing feed and food
business operator, or other points of the feed and food chain.

3.

These controls may also be carried out on goods that are:

(a) placed under one of the customs procedures referred to in
to (f) of Article 4(16) of Regulation (EEC)

points (b)
No 2913/92;

or

(b)

to enter free zones or free warehouses, as defined in
Article 4(15)(b) of Regulation (EEC) No 2913/92.

4.
Satisfactory results of checks referred to in paragraph 3 shall
neither affect the duty of feed and food business operators to
ensure that feed and food comply with feed and food law from
the moment of release for free circulation nor prevent further offi-
cial controls on the feed or food concerned from being carried
out.

A list of feed and food of non-animal origin that is, on the
5.
basis of known or emerging risk, to be subject to an increased
level of official controls at the point of entry into territories
referred to in Annex I shall be drawn up and updated, in accor-
dance with the procedure referred to in Article 62(3). The fre-
quency and nature of these controls shall be laid down in accor-
dance with the same procedure. At the same time, the fees related
to such controls may be established in accordance with the same
procedure.

Article 16

Types of checks on feed and food of non-animal origin

1.
The official controls referred to in Article 15(1) shall include
at least a systematic documentary check, a random identity check
and, as appropriate, a physical check.

Physical checks shall be carried out at a frequency depend-

2.
ing on:

(a)

the risks associated with different types of feed and food;

(b)

the history of compliance with the requirements for the
product concerned of the third country and establishment of
origin and of the feed or food business operators importing
and exporting the product;

(c)

the controls that the feed or food business operator import-
ing the product has carried out;

(d)

the guarantees that the competent authority of the third
country of origin has given.

3.
The Member States shall ensure that physical checks are car-
ried out under appropriate conditions and at a place with access
to appropriate control facilities allowing investigations to be con-
ducted properly, a number of samples adapted to the risk man-
agement to be taken, and the feed and food to be handled hygieni-
cally. Samples must be handled in such a way as to guarantee
both their legal and analytical validity. Member States shall ensure
that the equipment and methodology are adequate for measuring
the limit values laid down under Community or national
legislation.

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Article 17

Article 19

Points of entry and prior notification

Action following official controls on feed and food from
third countries

1. Member States shall, for the organisation of the official con-
trols referred to in Article 15(5):

— designate particular points of entry in their territory which
have access to the appropriate control facilities for different
types of feed and food;

1.
The competent authority shall place under official detention
feed or food from third countries that does not comply with feed
or food law and, having heard the feed or food business opera-
tors responsible for the consignment, it shall take the following
measures in respect of such feed or food:

and

— require feed and food business operators responsible for con-
signments to give prior notification of their arrival and
nature.

(a) order that such feed or food be destroyed, subjected to a spe-
cial treatment in accordance with Article 20 or re-dispatched
outside the Community in accordance with Article 21; other
appropriate measures such as the use of feed or food for pur-
poses other than those for which they were originally
intended may also be taken;

Member States may apply the same rules for other feed of non-
animal origin.

(b)

if the feed or food has already been placed on the market,
monitor or, if necessary, order its recall or withdrawal before
taking one of the measures referred to above;

2. Member States shall inform the Commission and other
Member States of any measures that they take in accordance with
paragraph 1.

(c) verify that feed and food does not give rise to any adverse
effects on human or animal health, either directly or through
the environment, during or pending the implementation of
any of the measures referred to in subparagraphs (a) and (b).

They shall design those measures in such a way as to avoid unnec-
essary disruption of trade.

2.

If, however:

Article 18

Action in case of suspicion

In case of suspicion of non-compliance or if there is doubt as to
the identity or the actual destination of the consignment, or as to
the correspondence between the consignment and the certified
guarantees, the competent authority shall carry out official con-
trols in order to confirm or to eliminate the suspicion or doubt.
The competent authority shall place the consignment concerned
under official detention until it obtains the results of such official
controls.

(a)

the official controls provided for in Articles 14 and 15 indi-
cate that a consignment is injurious to human or animal
health or unsafe, the competent authority shall place the con-
signment in question under official detention pending its
destruction or any other appropriate measure necessary to
protect human and animal health;

(b)

feed or food of non-animal origin for which an increased
level of controls has been laid down in accordance with

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Article 15(5) is not presented for official controls, or is not
presented in accordance with any specific requirements
established in accordance with Article 17, the competent
authority shall order that it be recalled and placed under offi-
cial detention without delay and that it be then either
destroyed or re-dispatched in accordance with Article 21.

(b)

the feed and food business operator has first informed the
competent authority of the third country of origin or third
country of destination, if different, of the reasons and circum-
stances preventing the placing on the market of the feed or
food concerned within the Community;

3. When it does not permit the introduction of feed or food,
the competent authority shall notify the Commission and other
Member States of its findings and of the identification of the prod-
ucts concerned in accordance with the procedure provided for in
Article 50(3) of Regulation (EC) No 178/2002 and shall notify its
decisions to the customs services, together with information as
regards the final destination of the consignment.

Decisions on consignments shall be subject to the right of

4.
appeal referred to in Article 54(3).

Article 20

Special treatment

1.

The special treatment referred to in Article 19 may include:

(a)

treatment or processing to bring the feed or food into line
with the requirements of Community law, or with the
requirements of a third country of re-dispatch, including
decontamination, where appropriate, but excluding dilution;

(b) processing in any other suitable manner for purposes other

than animal or human consumption.

and

(c) when the third country of destination is not the third coun-
try of origin, the competent authority of the third country of
destination has notified the competent authority of its pre-
paredness to accept the consignment.

2. Without prejudice to the national rules applicable with
respect to the time limits for applying for a supplementary expert
opinion, and where the results of official controls do not preclude
it, re-dispatch shall, as a general rule, take place no more than
60 days after the day on which the competent authority decided
on the destination of the consignment, unless legal action has
If, after the expiry of the 60-day period,
been undertaken.
re-dispatch does not
the consignment shall be
take place,
destroyed, unless a delay is justified.

3.
Pending re-dispatch of consignments or confirmation of the
reasons for rejection, the competent authority shall place consign-
ments under official detention.

2.
The competent authority shall ensure that special treatment
takes place in establishments under its control, or under the con-
trol of another Member State, and in accordance with conditions
laid down in accordance with the procedure referred to in
Article 62(3) or, in the absence of such conditions, with national
rules.

4.
The competent authority shall notify the Commission and
other Member States in accordance with the procedure provided
for in Article 50(3) of Regulation (EC) No 178/2002 and shall
notify its decisions to the customs services. Competent authori-
ties shall cooperate in accordance with Title IV to take any fur-
ther measures necessary to ensure that it is not possible to rein-
troduce the rejected consignments into the Community.

Article 21

Re-dispatch of consignments

Article 22

Costs

The competent authority shall allow re-dispatch of consign-

1.
ments only if:

(a)

the destination has been agreed with the feed or food busi-
ness operator responsible for the consignment; and

The feed or food business operator responsible for the consign-
ment or its representative shall be liable for the costs incurred by
competent authorities for the activities referred to in Articles 18,
19, 20 and 21.

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Article 23

Approval of pre-export checks by third countries

The competent authority or control body of the third coun-
6.
try shall ensure the official certification of each consignment
checked prior to its entry into one of the territories referred to in
Annex I. The approval referred to in paragraph 1 shall specify a
model for such certificates.

1.
Specific pre-export checks that a third country carries out
on feed and food immediately prior to export to the Community
with a view to verifying that the exported products satisfy Com-
munity requirements may be approved in accordance with the
procedure referred to in Article 62(3). The approval may apply
only to feed and food originating in the third country concerned
and may be granted for one or more products.

2. Where such approval has been granted, the frequency of
import controls for feed or food may be reduced as a conse-
quence. However, Member States shall carry out official controls
on feed and food imported in accordance with the approval
referred to in paragraph 1 so as to ensure that the pre-export
checks carried out in the third country remain effective.

The approval referred to in paragraph 1 may only be

3.
granted to a third country if:

7. Without prejudice to Article 50(3) of Regulation (EC)
No 178/2002, when official controls on imports subject to the
procedure referred to in paragraph 2 reveal significant non-
compliance, Member States shall immediately notify the Commis-
sion and other Member States and the operators concerned in
accordance with the procedure provided for in Title IV of this
Regulation; Member States shall increase the number of consign-
ments checked and, where necessary to allow a proper analytical
examination of the situation, keep an appropriate number of
samples under appropriate storage conditions.

8.
If it is found that, in a significant number of consignments,
the goods do not correspond to the information in the certificates
that the competent authority or control body of the third coun-
try has issued, the reduced frequency referred to in paragraph 2
shall no longer apply.

(a) a Community audit has shown that feed or food exported to
the Community meets Community requirements, or equiva-
lent requirements;

Article 24

Competent authorities and customs services

(b)

the controls carried out in the third country prior to dispatch
are considered sufficiently effective and efficient as to replace
or reduce the documentary, identity and physical checks laid
down in Community law.

1.
For the organisation of the official controls referred to in
this Chapter, the competent authorities and the customs services
shall cooperate closely.

4.
The approval referred to in paragraph 1 shall specify the
competent authority of the third country under the responsibility
of which the pre-export checks are performed and, if appropri-
ate, any control body to which that competent authority may del-
egate certain tasks. Such delegation may be approved only if it
meets the criteria of Article 5 or equivalent conditions.

2. With regard to consignments of feed and food of animal
origin and of feed and food referred to in Article 15(5), customs
services shall not allow their entry or handling in free zones or
free warehouses without
the competent
authority.

the agreement of

The competent authority and any control body specified in
shall be responsible for contacts with the

5.
the approval
Community.

3. Where samples are taken, the competent authority shall
inform the customs services and the operators concerned and
indicate whether or not the goods can be released before the
results of the analysis of the samples are available, provided the
traceability of the consignment is ensured.

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In the case of release for free circulation, competent authori-
4.
ties and customs services shall work together in accordance with
the requirements laid down in Articles 2 to 6 of Regulation (EEC)
No 339/93.

CHAPTER VI

FINANCING OF OFFICIAL CONTROLS

Article 25

Implementing measures

Article 26

General principle

1. Measures necessary to ensure the uniform implementation
of official controls on the introduction of feed and food shall be
laid down in accordance with the procedure referred to in
Article 62(3).

Member States shall ensure that adequate financial resources are
available to provide the necessary staff and other resources for
official controls by whatever means considered appropriate,
including through general taxation or by establishing fees or
charges.

2.

In particular, detailed rules may be laid down for:

(a)

feed and food imported or placed under one of the customs
procedures referred to in Article 4(16)(b) to (f) of Regulation
(EEC) No 2913/92 or that are to be handled in free zones or
free warehouses, as defined in Article 4(15)(b) of Regula-
tion (EEC) No 2913/92;

Article 27

Fees or charges

1. Member States may collect fees or charges to cover the costs
occasioned by official controls.

(b)

food for the supply of the crew and passengers of interna-
tional means of transport;

2.
However, as regards the activities referred to in Annex IV,
section A, and Annex V, section A, Member States shall ensure the
collection of a fee.

(c)

feed and food ordered remotely (for example, by mail, by
telephone or via the internet) and delivered to the consumer;

(d)

feed intended for pets or horses and food carried by passen-
gers and crew of international means of transport;

3. Without prejudice to paragraphs 4 and 6, fees collected as
regards the specific activities mentioned in Annex IV, section A
and Annex V, section A shall not be lower than the minimum
rates specified in Annex IV, section B and Annex V, section B.
However, for a transitional period until 1 January 2008, as regards
the activities referred to in Annex IV, section A, Member States
may continue to use the rates currently applied pursuant to
Directive 85/73/EEC.

(e)

specific conditions or exemptions concerning certain territo-
ries referred to in Article 3 of Regulation (EEC) No 2913/92,
so as to take account of the natural constraints specific to
those territories;

The rates in Annex IV, Section B and Annex V, Section B shall be
updated at least every two years, in accordance with the proce-
dure referred to in Article 62(3), in particular to take account of
inflation.

(f)

the purpose of ensuring the consistency of decisions by com-
petent authorities concerning feed and food from third coun-
tries within the framework of Article 19;

Fees collected for the purposes of official controls in accor-

4.
dance with paragraph 1 or 2:

(g) consignments of Community origin that are returned from a

(a)

third country;

shall not be higher than the costs borne by the responsible
competent authorities in relation to the items listed in
Annex VI;

(h) documents that must accompany consignments when

samples have been taken.

and

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(b) may be fixed at a flat-rate on the basis of the costs borne by
the competent authorities over a given period of time or,
where applicable, at the amounts fixed in Annex IV, section B
or in Annex V, section B.

Fees relating to import controls are to be paid by the opera-
8.
tor or his representative to the competent authority in charge of
import controls.

In setting the fees Member States

5.
consideration:

shall

take into

Fees shall not directly or indirectly be refunded, unless

9.
unduly collected.

(a)

the type of business concerned and relevant risk factors;

(b)

the interests of businesses with a low throughput;

(c)

traditional methods used for production, processing and
distribution;

10. Without prejudice to the costs deriving from the expenses
referred to in Article 28, Member States shall not collect any fees
other than those referred to in this Article for the implementa-
tion of this Regulation.

(d)

the needs of businesses located in regions subject to particu-
lar geographical constraints.

Operators or other relevant businesses or their represen-

11.
tatives shall receive proof of their payment of fees.

6. When, in view of own-check and tracing systems imple-
mented by the feed or food business as well as of the level of com-
pliance found during official controls, for a certain type of feed or
food or activities, official controls are carried out with a reduced
frequency or to take account of the criteria referred to in para-
graph 5(b) to (d), Member States may set the official control fee
below the minimum rates referred to in paragraph 4(b), provided
that the Member State concerned provides the Commission with
a report specifying:

12.
The Member States shall make public the method of cal-
culation of fees and communicate it to the Commission. The
Commission shall examine whether the fees comply with the
requirements of this Regulation.

(a)

the type of feed or food or activity concerned;

Article 28

Expenses arising from additional official controls

(b)

the controls performed in the feed and food business
concerned;

and

(c)

the method for calculating the reduction of the fee.

7. When the competent authority carries out several official
controls at the same time in a single establishment, it shall con-
sider these controls as a single activity and charge a single fee.

When the detection of non-compliance leads to official controls
that exceed the competent authority’s normal control activities,
the competent authority shall charge the operators responsible for
the non-compliance, or may charge the operator owning or keep-
ing the goods at the time when the additional official controls are
carried out, for the expenses arising from the additional official
controls. Normal control activities are the routine control activi-
ties required under Community or national law and, in particular,
those described in the plan provided for in Article 41. Activities
that exceed normal control activities include the taking and analy-
sis of samples as well as other controls that are required to check
the extent of a problem, to verify whether corrective action has
been taken, or to detect and/or substantiate non-compliance.

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Article 29

Level of expenses

Article 31

Registration/approval of feed and food business
establishments

When setting the level of expenses referred to in Article 28,
account shall be taken of the principles laid down in Article 27.

1.

CHAPTER VII

OTHER PROVISIONS

Article 30

Official certification

(a) Competent authorities shall establish procedures for
feed and food business operators to follow when apply-
ing for the registration of their establishments in accor-
dance with
852/2004,
Directive 95/69/EC or with the future regulation on feed
hygiene;

Regulation

(EC) No

1. Without prejudice to requirements concerning official cer-
tification adopted for animal health or animal welfare purposes,
requirements may be adopted, in accordance with the procedure
referred to in Article 62(3), concerning:

(a)

the circumstances in which official certification is required;

(b) model certificates;

(c) qualifications of the certifying staff;

(d)

the principles to be respected to ensure reliable certification,
including electronic certification;

(e)

the procedures to be followed in case of withdrawal of cer-
tificates and for replacement certificates;

(f)

consignments that are split into smaller consignments or that
are mixed with other consignments;

(g) documents that must follow goods after official controls have

been carried out.

2. Where official certification is required, it shall be ensured
that:

(a) a link exists between the certificate and the consignment;

(b)

the information in the certificate is accurate and authentic.

3.
A single model certificate shall, where appropriate, combine
requirements concerning the official certification of feed and food
and other requirements for official certification.

(b) They shall draw up and keep up to date a list of feed and
food business operators which have been registered.
Where such a list already exists for other purposes, it
may also be used for the purposes of this Regulation.

2.

(a) Competent authorities shall establish procedures for
feed and food business operators to follow when apply-
ing for the approval of their establishments in accor-
dance with Regulation (EC) No 852/2004, Regulation
(EC) No 854/2004, Directive 95/69/EC or with the
future regulation on feed hygiene.

(b) Upon receipt of an application for approval from a feed
or food business operator, the competent authority
shall make an on-site visit.

(c)

It shall approve an establishment for the activities con-
cerned only if the feed or food business operator has
demonstrated that it complies with the relevant require-
ments of feed or food law.

(d) The competent authority may grant conditional
approval if it appears that the establishment meets all
the infrastructure and equipment requirements. It shall
grant full approval only if it appears from a new official
control of the establishment, carried out within three
months of granting conditional approval, that the estab-
lishment meets the other relevant requirements of feed
or food law. If clear progress has been made but the
establishment still does not meet all of the relevant
requirements, the competent authority may prolong
conditional approval. However, conditional approval
shall not exceed a total of six months.

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(e) The competent authority shall keep the approval of
establishments under review when carrying out official
controls. If the competent authority identifies serious
deficiencies or has to stop production at an establish-
ment repeatedly and the feed or food business operator
is not able to provide adequate guarantees regarding
future production, the competent authority shall initiate
procedures to withdraw the establishment’s approval.
However, the competent authority may suspend an
establishment’s approval if the feed or food business
operator can guarantee that it will resolve deficiencies
within a reasonable time;

(f)

collaborating with laboratories responsible for analysing feed
and food in third countries.

The Community reference laboratories in the animal health

2.
sector shall be responsible for:

(a) coordinating the methods employed in the Member States for

diagnosing diseases;

(f) The competent authorities shall maintain up-to--date
lists of approved establishments and make them avail-
able to other Member States and to the public in a man-
ner that may be specified in accordance with the proce-
dure referred to in Article 62(3).

(b) assisting actively in the diagnosis of disease outbreaks in
Member States by receiving pathogen isolates for confirma-
tory diagnosis, characterisation and epizootic studies;

TITLE III

REFERENCE LABORATORIES

Article 32

Community reference laboratories

(c)

facilitating the initial or further training of experts in labora-
tory diagnosis with a view to the harmonisation of diagnos-
tic techniques throughout the Community;

(d) collaborating, as regards methods of diagnosing animal dis-
eases falling within their competence, with the competent
laboratories in third countries where those diseases are
prevalent:

The Community reference laboratories for feed and food

1.
referred to in Annex VII shall be responsible for:

(e)

conducting initial and further training courses for the benefit
of staff from national reference laboratories and of experts
from developing countries;

(a) providing national reference laboratories with details of ana-

lytical methods, including reference methods;

Article 12(2) and (3) shall apply to Community reference

3.
laboratories.

(b) coordinating application by the national reference laborato-
ries of the methods referred to in (a), in particular by organ-
ising comparative testing and by ensuring an appropriate
follow-up of such comparative testing in accordance with
internationally accepted protocols, when available;

(c)

coordinating, within their area of competence, practical
arrangements needed to apply new analytical methods and
informing national reference laboratories of advances in this
field;

(d) conducting initial and further training courses for the benefit
of staff from national reference laboratories and of experts
from developing countries;

Community reference laboratories shall fulfil the following

4.
requirements. They must:

(a) have suitably qualified staff with adequate training in diag-
nostic and analytical techniques applied in their area of
competence;

(b) possess the equipment and products needed to carry out the

tasks assigned to them;

(c) have an appropriate administrative infrastructure;

(e) providing scientific and technical assistance to the Commis-
sion, especially in cases where Member States contest the
results of analyses;

(d) ensure that their staff respect the confidential nature of cer-

tain subjects, results or communications;

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(e) have sufficient knowledge of international standards and

2

These national reference laboratories shall:

practices;

(f) have available, if appropriate, an updated list of available ref-
erence substances and reagents and an updated list of manu-
facturers and suppliers of such substances and reagents;

(a)

collaborate with the Community reference laboratory in their
area of competence;

(g)

take account of research activities at national and Commu-
nity level;

(b) coordinate, for their area of competence, the activities of offi-
cial laboratories responsible for the analysis of samples in
accordance with Article 11;

(h) have trained personnel available for emergency situations

occurring within the Community.

(c) where appropriate, organise comparative tests between the
laboratories and ensure an appropriate

official national
follow-up of such comparative testing;

Other Community reference laboratories relevant to the
5.
areas referred to in Article 1 may be included in Annex VII in
accordance with the procedure referred to in Article 62(3). In
accordance with the same procedure, Annex VII may be updated.

6.
Additional responsibilities and tasks for Community refer-
ence laboratories may be laid down in accordance with the pro-
cedure referred to in Article 62(3).

7.
Community reference laboratories may be granted a Com-
munity financial contribution in accordance with Article 28 of
Council Decision 90/424/EEC of 26 June 1990 on expenditure in
the veterinary field (1).

Community reference laboratories may be subject to Com-
8.
munity controls to verify compliance with the requirements of
this Regulation. If these controls find that a laboratory is not com-
plying with those requirements or tasks for which they have been
designated, necessary measures may be taken in accordance with
the procedure referred to in Article 62(3).

9.
Paragraphs 1 to 7 shall apply without prejudice to more
specific rules, and in particular Chapter VI of Regulation (EC)
No 999/2001 and Article 14 of Directive 96/23/EC.

(d) ensure the dissemination to the competent authority and offi-
cial national laboratories of information that the Community
reference laboratory supplies;

(e) provide scientific and technical assistance to the competent
authority for the implementation of coordinated control
plans adopted in accordance with Article 53;

(f) be responsible for carrying out other specific duties provided
for
in accordance with the procedure referred to in
Article 62(3), without prejudice to existing additional
national duties.

Article 12(2) and (3) shall apply to national reference

3.
laboratories.

4. Member States shall communicate the name and address of
each national reference laboratory to the Commission, the rel-
evant Community reference laboratory and other Member States.

Article 33

National reference laboratories

5. Member States that have more than one national reference
laboratory for a Community reference laboratory must ensure
that these laboratories work closely together, so as to ensure effi-
cient coordination between them, with other national laborato-
ries and with the Community reference laboratory.

1. Member States shall arrange for the designation of one or
more national reference laboratories for each Community refer-
ence laboratory referred to in Article 32. A Member State may
designate a laboratory situated in another Member State or Euro-
pean Free Trade Association (EFTA) Member and a single labora-
tory may be the national reference laboratory for more than one
Member State.

6.
Additional responsibilities and tasks for national reference
laboratories may be laid down in accordance with the procedure
referred to in Article 62(3).

(1) OJ L 224, 18.8.1990, p. 19. Decision as last amended by Regulation

(EC) No 806/2003.

7.
Paragraphs 1 to 5 shall apply without prejudice to more
specific rules and in particular Chapter VI of Regulation (EC)
No 999/2001 and Article 14 of Directive 96/23/EC.

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TITLE IV

ADMINISTRATIVE ASSISTANCE AND COOPERATION
IN THE AREAS OF FEED AND FOOD

Article 34

General principles

1. Where the outcome of official controls on feed and food
requires action in more than one Member State, competent
authorities in the Member States concerned shall provide each
other with administrative assistance.

Competent authorities shall provide administrative assis-
2.
tance upon request, or spontaneously when the course of inves-
tigations so requires. Administrative assistance may include,
where appropriate, participation in on-the-spot controls that the
competent authority of another Member State carries out.

Articles 35 to 40 shall not prejudice national rules appli-
3.
cable to the release of documents that are the object of, or are
related to, court proceedings, or rules aimed at the protection of
natural or legal persons’ commercial interests.

Article 35

Liaison bodies

1.
Each Member State shall designate one or more liaison bod-
ies to liaise as appropriate with other Member States’ liaison bod-
ies. The role of liaison bodies shall be to assist and coordinate
communication between competent authorities and, in particu-
lar, the transmission and reception of requests for assistance.

2. Member States shall inform the Commission and other
Member States of all the relevant details of their designated liai-
son bodies, and of any modification of these details.

The

competent

to which

Council
authorities
4.
Directive 89/608/EEC of 21 November 1989 on mutual assis-
tance between the administrative authorities of the Member States
and cooperation between the latter and the Commission to ensure
correct application of the legislation on veterinary and zootech-
nical matters (1) applies, shall
liaise as appropriate with the
authorities operating under this title.

Article 36

Assistance on request

Upon receiving a reasoned request, the requested competent
1.
authority shall ensure that the requesting competent authority is
provided with all necessary information and documents enabling
the latter to verify compliance with feed and food law within its
jurisdiction. For that purpose, the requested competent authority
shall arrange for the conduct of any administrative enquiries nec-
essary to obtain such information and documents.

2.
Information and documents provided pursuant to para-
graph 1 shall be forwarded without undue delay. Documents may
be transmitted in their original form or copies may be provided.

3.
By agreement between the requesting authority and the
requested authority, staff designated by the requesting authority
may be present during administrative enquiries.

Such enquiries shall always be carried out by staff of the requested
authority.

The requesting authority’s staff may not, on their own initiative,
exercise the powers of enquiry conferred on officials of the
requested authority. They shall, however, have access to the same
premises and documents as the latter, through their intermediary,
and for the sole purpose of the administrative enquiry being car-
ried out.

3. Without prejudice to paragraph 1, the designation of liai-
son bodies shall not preclude direct contacts, exchange of infor-
mation or cooperation between the staff of competent authori-
ties in different Member States.

4.
Staff of the requesting authority present in another Member
State in accordance with paragraph 3 shall at all times be able to
produce written authority stating their identity and their official
capacity.

(1) OJ L 351, 2.12.1989, p. 34.

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Article 37

Assistance without request

1. When a competent authority becomes aware of non-
compliance, and if such non-compliance may have implications
for another Member State or States, it shall pass such information
to the other Member State(s) without prior request and without
delay.

2. Member States receiving such information shall investigate
the matter and inform the Member State that provided the infor-
mation of the results of this investigation and, where appropriate,
of any measures taken.

Article 38

Assistance in the event of non-compliance

1.
If, during an official control carried out at the place of des-
tination of the goods, or during their transport, the competent
authority of the Member State of destination establishes that the
goods do not comply with feed or food law in such a way as to
create a risk to human or animal health or to constitute a serious
infringement of feed or food law, it shall contact the competent
authority of the Member State of dispatch without delay.

If the third country has given a legal undertaking to provide
2.
the assistance required to gather evidence of the irregular nature
of transactions that are or appear to be contrary to the relevant
feed and food law, information obtained under this Regulation
may be communicated to that third country, with the consent of
the competent authorities that supplied the information, in accor-
dance with laws applying to the communication of personal data
to third countries.

Article 40

Coordinated assistance and follow-up by the Commission

The Commission shall coordinate without delay the action
1.
undertaken by Member States when it, further to information
received from Member States or from other sources, becomes
aware of activities that are, or appear to be, contrary to feed or
food law and are of particular interest at Community level, and in
particular when:

(a)

such activities have, or might have, ramifications in several
Member States;

(b)

it appears that similar activities have been carried out in sev-
eral Member States;

2.
The competent authority of the Member State of dispatch
shall investigate the matter, take all necessary measures and notify
the competent authority of the Member State of destination of the
nature of the investigations and official controls carried out, the
decisions taken and the reasons for such decisions.

or

3.
If the competent authority of the Member State of destina-
tion has reason to believe that such measures are inadequate, the
two Member States’ competent authorities shall together seek
ways and means of remedying the situation including, if appro-
priate, a joint on-the-spot inspection carried out in accordance
with Article 36(3) and (4). They shall inform the Commission if
they are not able to agree on appropriate measures.

Article 39

Relations with third countries

1. When a competent authority receives information from a
third country indicating non-compliance and/or a risk to human
or animal health, that authority shall pass that information on to
competent authorities in other Member States if it considers that
they might be interested in it or if they request it. It shall also com-
municate such information to the Commission whenever it is of
relevance at Community level.

(c) Member States are unable to agree on appropriate action to

address non-compliance.

2. When official controls at destination show repeated non-
compliance or other risks to humans, plants or animals from feed
or food, either directly or through the environment, the compe-
tent authority of the Member State of destination shall inform the
Commission and the competent authorities of the other Member
States without delay.

3.

The Commission may:

(a)

in collaboration with the Member State concerned, send an
inspection team to carry out an official control on the spot;

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(b)

request that the competent authority of the Member State of
dispatch intensify relevant official controls and report on the
action and measures taken.

(c)

the designation of competent authorities and their tasks at
central, regional and local level, and on resources available to
these authorities;

4. Where the measures provided for in paragraphs 2 and 3 are
taken to deal with repeated non-compliance by a feed or food
business, the competent authority shall charge any expenses aris-
ing from such measures to the business in question.

(d)

the general organisation and management of official controls
at national, regional and local level, including official controls
in individual establishments;

TITLE V

CONTROL PLANS

Article 41

Multi-annual national control plans

In order to ensure the effective implementation of Article 17(2)
of Regulation (EC) No 178/2002, of animal health and animal
welfare rules and of Article 45 of this Regulation, each Member
State shall prepare a single integrated multi-annual national con-
trol plan.

Article 42

Principles for the preparation of multi-annual national
control plans

1. Member States shall:

(e)

control systems applied to different sectors and coordination
between the different services of competent authorities
responsible for official controls in these sectors;

(f) where appropriate, the delegation of tasks to control bodies;

(g) methods to ensure compliance with the operational criteria

of Article 4(2);

(h)

the training of staff performing official controls referred to in
Article 6;

(i)

the documented procedures referred to in Articles 8 and 9;

(j)

the organisation and operation of contingency plans for ani-
mal or food-borne disease emergencies, feed and food con-
tamination incidents and other human health risks;

(a)

implement the plan referred to in Article 41 for the first time
no later than 1 January 2007;

(k)

the organisation of cooperation and mutual assistance.

and

3. Multi-annual national control plans may be adjusted during
their implementation. Amendments may be made in the light of,
or in order to take account of, factors including:

(b)

regularly update it in the light of developments;

and

(a) new legislation;

(c) provide the Commission with the latest version of the plan

on request.

2.
Each multi-annual national control plan shall contain gen-
eral information on the structure and organisation of the systems
of feed and food control, and of animal health and animal wel-
fare control in the Member State concerned, in particular on:

(b)

the emergence of new diseases or other health risks;

(c)

significant changes to the structure, management or opera-
tion of the competent national authorities;

(d)

the results of Member States’ official controls;

(a)

the strategic objectives of the plan and on how the prioriti-
sation of controls and allocation of resources reflect these
objectives;

(e)

the results of Community controls carried out in accordance
with Article 45;

(b)

the risk categorisation of the activities concerned;

(f)

any amendment of the guidelines referred to in Article 43;

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(g)

scientific findings;

(j)

lay down the structure of, and information to be included in,
the annual reports required in Article 44;

(h)

the outcome of audits performed by a third country in a
Member State.

Article 43

Guidelines for multi-annual national control plans

The multi-annual national control plans referred to in
1.
Article 41 shall take account of guidelines to be drawn up by the
Commission in accordance with the procedure referred to in
Article 62(2). These guidelines shall in particular:

(a) promote a consistent, comprehensive and integrated
approach to official controls of feed and food, animal health
and animal welfare legislation, and embrace all sectors and all
stages of the feed and food chain, including import and
introduction;

(b)

identify risk-based priorities and criteria for the risk categori-
sation of the activities concerned and the most effective con-
trol procedures;

(c)

identify other priorities and the most effective control
procedures;

(d)

identify the stages of production, processing and distribution
of feed and food, including the use of feed, which will pro-
vide the most reliable and indicative information about com-
pliance with feed and food law;

(e)

encourage the adoption of best practices at all levels of the
control system;

(k)

indicate the main performance indicators to be applied in
assessing multi-annual national control plans.

2. Where necessary, the guidelines shall be adapted in the light
of the analysis of annual reports that Member States submit in
accordance with Article 44 or Community controls carried out
in accordance with Article 45.

Article 44

Annual reports

1.
One year after starting the implementation of multi-annual
national control plans, and subsequently every year, Member
States shall submit to the Commission a report indicating:

(a) any amendments made to multi-annual national control
referred to in

to take account of

the factors

plans
Article 42(3);

(b)

the results of controls and audits conducted in the previous
year under the provisions of the multi-annual national con-
trol plan;

(c)

the type and number of cases of non-compliance identified;

(f)

encourage the development of effective controls on traceabil-
ity systems;

(d) actions to ensure the effective operation of multi-annual
national control plans, including enforcement action and its
results.

(g) provide advice on the development of systems to record the

performance and results of control actions;

(h)

reflect relevant international bodies’ standards and recom-
mendations regarding the organisation and operation of offi-
cial services;

In order to promote the consistent presentation of this
2.
report and in particular of the results of official controls, the infor-
mation referred to in paragraph 1 shall take account of guidelines
to be drawn up by the Commission in accordance with the pro-
cedure referred to in Article 62(2).

(i)

lay down criteria for the conduct of the audits referred to in
Article 4(6);

3. Member States shall finalise their reports and transmit them
to the Commission, within six months of the end of the year to
which the reports relate.

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In the light of the reports referred to in paragraph 1, the
4.
outcome of Community controls carried out in accordance with
Article 45 and any other relevant information, the Commission
shall establish an annual report on the overall operation of offi-
cial controls in Member States. This report may, where appropri-
ate, include recommendations on:

(a) possible improvements to official control and audit systems
in Member States, including their scope, management and
implementation;

Specific audits and inspections in one or more specific areas
2.
may supplement general audits. These specific audits and inspec-
tions shall in particular serve to:

(a) verify the implementation of the multi-annual national con-
trol plan, feed and food law and animal health and animal
welfare legislation and may include, as appropriate, on-the-
spot inspections of official services and of facilities associated
with the sector being audited;

(b)

specific control actions concerning sectors or activities,
regardless of whether these are covered by multi-annual
national control plans;

(b) verify the functioning and organisation of competent

authorities;

(c)

coordinated plans aiming at addressing issues of particular
interest.

(c)

investigate important or recurring problems in Member
States;

5. Multi-annual national control plans and the related guide-
lines shall, where appropriate, be adapted on the basis of the con-
clusions and recommendations contained in the Commission’s
report.

(d)

investigate emergency situations, emerging problems or new
developments in Member States.

6.
The Commission shall submit its report to the European
Parliament and the Council and make it available to the public.

TITLE VI

COMMUNITY ACTIVITIES

CHAPTER I

COMMUNITY CONTROLS

Article 45

Community controls in Member States

1.
Commission experts shall carry out general and specific
audits in Member States. The Commission may appoint experts
from Member States to assist its own experts. General and spe-
cific audits shall be organised in cooperation with Member States’
competent authorities. Audits shall be carried out on a regular
basis. Their main purpose shall be to verify that, overall, official
controls take place in Member States in accordance with the
multi-annual national control plans referred to in Article 41 and
in compliance with Community law. For this purpose, and in
order to facilitate the efficiency and effectiveness of the audits,
the Commission may, in advance of carrying out such audits,
request that the Member States provide, as soon as possible,
up-to-date copies of national control plans.

3.
The Commission shall report on the findings of each con-
trol carried out. Its report shall, if appropriate, contain recom-
mendations for Member States on the improvement of compli-
ance with feed and food law and animal health and animal welfare
rules. The Commission shall make its reports publicly available.
In the case of reports on controls carried out in a Member State,
the Commission shall provide the relevant competent authority
with a draft report for comments, take those comments into con-
sideration in preparing the final report and publish the compe-
tent authority’s comments together with the final report.

4.
The Commission shall establish an annual control pro-
gramme, communicate it to Member States in advance, and report
on its results. The Commission may amend the programme to
take account of developments in the fields of feed and food safety,
animal health, animal welfare and plant health.

5. Member States shall:

(a)

take appropriate follow-up action in the light of the recom-
mendations resulting from Community controls;

(b) give all necessary assistance and provide all documentation
and other technical support that Commission experts request
to enable them to carry out controls efficiently and
effectively;

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(c)

ensure that Commission experts have access to all premises
or parts of premises and to information, including comput-
ing systems, relevant to the execution of their duties.

(h)

the assurances which the third country can give regarding
compliance with,
to, Community
requirements.

equivalence

or

6.
Detailed rules concerning Community controls in Member
States may be drawn up or amended in accordance with the pro-
cedure referred to in Article 62(3).

2.
In order to facilitate the efficiency and effectiveness of the
controls in a third country, the Commission may, in advance of
carrying out such controls, request that the third country con-
cerned provide the information referred to in Article 47(1) and,
where appropriate, the written records on the implementation of
such controls.

Article 46

Community controls in third countries

The frequency of Community controls in third countries

3.
shall be determined on the basis of:

1.
Commission experts may carry out official controls in third
countries in order to verify, on the basis of the information
referred to in Article 47(1), the compliance or equivalence of
third-country legislation and systems with Community feed and
food law and Community animal health legislation. The Commis-
sion may appoint experts from Member States to assist its own
experts. Such official controls shall have particular regard to:

(a) a risk assessment of

the products exported to the

Community;

(b)

the provisions of Community legislation;

(a)

the legislation of the third country;

(b)

the organisation of the third country’s competent authorities,
their powers and independence, the supervision to which
they are subject and the authority they have to enforce the
applicable legislation effectively;

(c)

the volume and nature of
concerned;

imports from the country

(d)

the results of controls that the Commission services or other
inspection bodies have already carried out;

(e)

the results of import controls and of any other controls that
competent authorities of Member States have carried out;

(c)

the training of staff in the performance of official controls;

(f)

information received from the European Food Safety Author-
ity or similar bodies;

(d)

the resources including diagnostic facilities available to com-
petent authorities;

(g)

information received from internationally recognised bodies
such as the World Health Organisation (WHO), the Codex
Alimentarius Commission and the World Organisation for
Animal Health (OIE), or from other sources;

(e)

the existence and operation of documented control proce-
dures and control systems based on priorities;

(h) evidence of emerging disease situations or other circum-
stances that might result in live animals, live plants or feed or
food imported from a third country presenting health risks;

(f) where applicable, the situation regarding animal health,
zoonoses and plant health, and procedures for notifying the
Commission and relevant international bodies of outbreaks
of animal and plant diseases;

(i)

the need to investigate or respond to emergency situations in
individual third countries.

(g)

the extent and operation of official controls on imports of
animals, plants and their products;

The criteria for determining risk for the purpose of the risk assess-
ment referred to in point (a) shall be decided in accordance with
the procedure referred to in Article 62(3).

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The procedure and detailed rules for controls in third coun-
4.
tries may be determined or amended in accordance with the pro-
cedure referred to in Article 62(3).

(b) any control and inspection procedures, production and quar-
antine treatment, pesticide tolerance and food additive
approval procedures operated within its territory;

They shall include, in particular, procedures for and detailed rules
on:

(a)

controls in third countries in the context of a bilateral
agreement;

(c)

risk-assessment procedures, factors taken into consideration,
as well as the determination of the appropriate level of sani-
tary or phytosanitary protection;

(b) controls in other third countries.

(d) where appropriate, the follow-up given to the recommenda-
tions made pursuant to controls referred to in Article 46.

According to the same procedure, charges for the abovemen-
tioned controls may be established on a reciprocal basis.

If, during a Community control, a serious risk to human or
5.
animal health is identified, the Commission shall immediately
take any necessary emergency measures in accordance with
Article 53 of Regulation (EC) No 178/2002 or safeguard provi-
sions in other relevant Community legislation.

2.
The information referred to in paragraph 1 shall be propor-
tionate to the nature of the goods and may take account of the
specific situation and structure of the third country and the nature
of the products exported to the Community. Its scope shall cover
at least the goods intended to be exported to the Community.

6.
The Commission shall report on the findings of each Com-
munity control carried out. Its report shall, if appropriate, con-
tain recommendations. The Commission shall make its reports
publicly available.

The information referred to in paragraphs 1 and 2 may also

3.
relate to:

The Commission shall communicate its programme of con-
7.
trols in third countries to Member States in advance and report on
the results. It may amend the programme to take account of
developments in the fields of feed and food safety, animal health
and plant health.

(a)

results of the national controls carried out on goods intended
to be exported to the Community;

CHAPTER II

IMPORT CONDITIONS

Article 47

General import conditions

1.
The Commission shall be responsible for requesting third
countries intending to export goods to the Community to pro-
vide the following accurate and up-to-date information on the
general organisation and management of sanitary control
systems:

(a) any sanitary or phytosanitary regulations adopted or pro-

posed within its territory;

(b)

important changes which have been made to the structure
and functioning of the relevant control systems, in particular
to meet Community requirements or recommendations.

4. Where a third country does not provide such information
or where such information is inadequate, specific import condi-
tions may be fixed in accordance with the procedure referred to
in Article 62(3) on a case by case and strictly temporary basis fol-
lowing consultations with the third country concerned.

5.
Guidelines, specifying how the information referred to in
paragraphs 1, 2 and 3 shall be drawn up and presented to the
Commission, as well as transitional measures allowing time for
third countries to prepare this information shall be established in
accordance with the procedure referred to in Article 62(2).

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Article 48

(e)

the guarantees given by a third country that:

Specific import conditions

1.
To the extent that the conditions and detailed procedures to
be respected when importing goods from third countries or their
regions are not provided for by Community law and in particular
by Regulation (EC) No 854/2004, they shall, if necessary, be laid
down in accordance with the procedure referred to in
Article 62(3).

The conditions and detailed procedures referred to in para-

2.
graph 1 may include:

(a)

the establishment of a list of third countries from which spe-
cific products may be imported into one of the territories
referred to in Annex I;

(b)

the establishment of models of certificates accompanying
consignments;

(c)

special import conditions, depending on the type of product
or animal and the possible risks associated therewith.

3.
Third countries shall appear on the lists referred to in para-
graph 2(a) only if their competent authorities provide appropri-
ate guarantees as regards compliance or equivalence with Com-
munity feed and food law and animal health rules.

4. When drawing up or updating lists, particular account shall
be taken of the following criteria:

(a)

the third country’s legislation in the sector concerned;

(i)

conditions applied to the establishments from which
feed and food may be imported in the Community com-
ply with or are equivalent to the requirements in Com-
munity feed and food law;

(ii) a list of such establishments is drawn up and kept up to

date;

(iii) the list of establishments and its updated versions are
communicated to the Commission without delay;

(iv) the establishments are the subject of regular and effec-
tive controls by the competent authority of the third
country.

5. When adopting the special import conditions referred to in
paragraph 2(c), account shall be taken of information that the
third countries concerned have provided and, where necessary,
the results of Community controls carried out in such third coun-
tries. Special import conditions may be established for a single
product or for a group of products. They may apply to a single
third country, to regions of a third country, or to a group of third
countries.

Article 49

Equivalence

1.
Following the implementation of an equivalence agreement,
or a satisfactory audit, a decision may be taken, in accordance
with the procedure referred to in Article 62(3), recognising that
measures that third countries or their regions apply in specific
areas offer guarantees equivalent to those applied in the Commu-
nity, if the third countries supply objective proof in this respect.

The decision referred to in paragraph 1 shall set out the con-
2.
ditions governing the imports from that third country or region
of a third country.

(b)

the structure and organisation of the competent authority of
the third country and its control services, as well as the pow-
ers available to it/them and the guarantees that can be pro-
vided with regard to the implementation of the legislation
concerned;

The conditions may include:

(a)

the nature and content of the certificates that must accom-
pany the products;

(c)

the existence of adequate official controls;

(b)

specific requirements applicable to importation into the
Community;

(d)

the regularity and rapidity of information supplied by the
third country on the presence of hazards in feed and food,
and in live animals;

(c) where necessary, procedures for drawing up and amending
lists of regions or establishments from which imports are
permitted.

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The decision referred to in paragraph 1 shall be repealed in
3.
accordance with the same procedure and without delay where any
of the conditions for recognition of equivalence established at the
time of its adoption cease to be fulfilled.

Article 50

Support for developing countries

In accordance with the procedure referred to in Article 62(3)
1.
the following measures may be adopted and maintained so long
as they have a demonstrable effect in ensuring that developing
countries are able to comply with the provisions of
this
Regulation:

(a) a phased introduction of the requirements referred to in
Articles 47 and 48 for products exported to the Community.
Progress in meeting these requirements shall be evaluated
and taken into account in determining the need for specified
time-limited exemptions in whole or in part from the require-
ments. The phased introduction shall also take into account
the progress in building the institutional capacity referred to
in paragraph 2;

(b) assistance with providing the information referred to in

Article 47, if necessary by Community experts;

(c)

the promotion of joint projects between developing coun-
tries and Member States;

(d)

the development of guidelines to assist developing countries
in organising official controls on products exported to the
Community;

(e)

sending Community experts to developing countries so as to
assist in the organisation of official controls;

(f)

the participation of control staff from developing countries
in the training courses referred to in Article 51.

CHAPTER III

TRAINING OF CONTROL STAFF

Article 51

Training of control staff

1.
The Commission may organise training courses for the staff
of the competent authorities of Member States responsible for the
official controls referred to in this Regulation. These training
courses shall serve to develop a harmonised approach to official
controls in Member States. They may include in particular train-
ing on:

(a) Community feed and food law and animal health and animal

welfare rules;

(b) control methods and techniques, such as the auditing of sys-
tems that operators design to comply with feed and food law,
animal health and animal welfare rules;

(c)

controls to be carried out on goods imported into the
Community;

(d)

feed and food production, processing and marketing meth-
ods and techniques.

The training courses referred to in paragraph 1 may be open
in particular developing

2.
to participants from third countries,
countries.

3.
Detailed rules for the organisation of training courses may
be laid down in accordance with the procedure referred to in
Article 62(3).

CHAPTER IV

OTHER COMMUNITY ACTIVITIES

Article 52

Third-country controls in Member States

1.
Commission experts may, at the request of and in coopera-
tion with the competent authorities of Member States, assist
Member States during controls that third countries carry out.

2.
In the context of the Community’s development coopera-
tion policy, the Commission shall promote support to develop-
ing countries with regard to feed and food safety in general and
compliance with feed and food standards in particular, in order to
build the institutional capacity required to meet the requirements
referred to in Articles 5, 12, 47 and 48.

2.
In such cases, Member States in whose territory a third
country is to carry out a control shall inform the Commission
about the planning, scope, documentation and any other relevant
information enabling the Commission to take part effectively in
the control.

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3.

The Commission’s assistance shall serve in particular to:

(b)

the restriction or prohibition of the placing on the market,
import or export of feed, food or animals;

(a)

clarify Community feed and food law and animal health and
animal welfare rules;

(b) provide information and data available at Community level
that may be useful for the control carried out by the third
country;

(c)

ensure uniformity with regard to controls carried out by third
countries.

Article 53

Coordinated control plans

(c) monitoring and, if necessary, ordering the recall, withdrawal

and/or destruction of feed or food;

(d)

the authorisation to use feed or food for purposes other than
those for which they were originally intended;

(e)

the suspension of operation or closure of all or part of the
business concerned for an appropriate period of time;

(f)

the suspension or withdrawal of the establishment’s approval;

The Commission may recommend coordinated plans in accor-
dance with the procedure referred to in Article 62(2). These plans
shall be:

(g)

the measures referred to in Article 19 on consignments from
third countries;

(a) organised annually in accordance with a programme;

appropriate.

(h) any other measure

the

competent

authority deems

and

(b) where considered necessary, organised on an ad hoc basis, in
particular with a view to establishing the prevalence of haz-
ards in feed, food or animals.

The competent authority shall provide the operator con-

3.
cerned, or a representative, with:

(a) written notification of its decision concerning the action to
be taken in accordance with paragraph 1, together with the
reasons for the decision;

TITLE VII

ENFORCEMENT MEASURES

and

CHAPTER I

NATIONAL ENFORCEMENT MEASURES

Article 54

Action in case of non-compliance

1. When the competent authority identifies non-compliance, it
shall take action to ensure that the operator remedies the situa-
tion. When deciding which action to take, the competent author-
ity shall take account of the nature of the non-compliance and
that operator’s past record with regard to non-compliance.

Such action shall include, where appropriate, the following

2.
measures:

(a)

the imposition of sanitation procedures or any other action
deemed necessary to ensure the safety of feed or food or
compliance with feed or food law, animal health or animal
welfare rules;

(b)

information on rights of appeal against such decisions and
on the applicable procedure and time limits.

4. Where appropriate, the competent authority shall also
notify the competent authority of the Member State of dispatch
of its decision.

All expenditure incurred pursuant to this Article shall be

5.
borne by the responsible feed and food business operator.

Article 55

Sanctions

1. Member States shall lay down the rules on sanctions appli-
cable to infringements of feed and food law and other Commu-
nity provisions relating to the protection of animal health and
welfare and shall take all measures necessary to ensure that they
are implemented. The sanctions provided for must be effective,
proportionate and dissuasive.

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2. Member States shall notify the provisions applicable to
infringements of feed and food law and any subsequent amend-
ment to the Commission without delay.

2.

In Article 30, the part of paragraph 1 beginning ‘Where such
additional checks demonstrate…’ and ending ‘…or to use it
for other purposes authorised by Community legislation,
without indemnity or compensation’,
is replaced by the
following:

CHAPTER II

COMMUNITY ENFORCEMENT MEASURES

Article 56

Safeguard measures

‘Where checks demonstrate the presence of unauthorised
substances or products or when maximum limits have been
exceeded, the provisions of Articles 19 to 22 of Regulation
(EC) No 882/2004 shall apply.’

1. Measures shall be taken under the procedures provided for
in Article 53 of Regulation (EC) No 178/2002 if:

3. Annex V is deleted.

(a)

the Commission has evidence of a serious failure in a Mem-
ber State’s control systems;

Article 58

Amendment of Directive 97/78/EC

and

Directive 97/78/EC is hereby amended as follows:

(b)

such failure may constitute a possible and widespread risk for
human health, animal health or animal welfare, either directly
or through the environment.

1. Article 1 is replaced by the following:

2

Such measures shall be adopted only after:

(a) Community controls have shown and reported non-

compliance with Community legislation;

and

(b)

the Member State concerned has failed to correct the situa-
tion upon request and within the time limit set by the
Commission.

‘Veterinary checks on products from third countries intro-
duced into one of the territories listed in Annex I shall be car-
ried out by Member States in accordance with this Directive
and with Regulation (EC) No 882/2004 of the European Par-
liament and of the Council of 29 April 2004 on official con-
trols performed to ensure the verification of compliance with
feed and food law, animal health and animal welfare rules (*).

(*) OJ L 165, 30.4.2004, p. 1.’

2. Article 2(2)(a) is replaced by the following:

TITLE VIII

‘(a)

ADAPTATION OF COMMUNITY LEGISLATION

Article 57

Amendment of Directive 96/23/EC

Directive 96/23/EC is hereby amended as follows:

1. Article 14(2) is replaced by the following:

‘2
The Community reference laboratories shall be those
referred to in the relevant part of Annex VII of Regulation
(EC) No 882/2004 of the European Parliament and of the
Council 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 (*).

(*) OJ L 165, 30.4.2004, p. 1.’

in

human

“products” means the products of animal origin referred
to in Directives 89/662/EEC and 90/425/EEC, in Regu-
lation (EC) No 1774/2002 of the European Parliament
and of the Council of 3 October 2002 laying down
health rules concerning animal by-products not intended
for
Council
consumption (*),
Directive 2002/99/EC of 16 December 2002 laying
down the animal health rules governing the production,
processing, distribution and introduction of products of
animal origin for human consumption (**) and in Regu-
lation (EC) No 854/2004 of the European Parliament
and of the Council of 29 April 2004 laying down spe-
cific rules for the organisation of official controls on
products of animal origin intended for human consump-
tion (***); it also includes the plant products referred to
in Article 19.

(*) OJ L 273, 10.10.2002, p. 1. Regulation as last amended
by Commission Regulation (EC) No 808/2003 (OJ
L 117, 13.5.2003, p. 1).

(**) OJ L 18, 23.1.2003, p. 11.
(***) OJ L 139, 30.4.2004.’

3.

4.

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‘inspection fees referred to in Council
In Article 7(3),
Directive 85/73/EEC of 29 January 1985 on the financing of
veterinary
by
and
Directives 89/662/EEC, 90/425/EEC, 90/675/EEC and
91/496/EEC (amended and consolidated)’ is replaced by the
following:

inspections

controls

covered

Article 60

Amendment of Regulation (EC) No 854/2004

Regulation (EC) No 854/2004 is hereby amended as follows:

‘inspection fees referred to in Regulation (EC) No 882/2004’.

1.

In Article 1, the following paragraph is added:

In Article 10(1)(b), the following phrase is deleted: ‘or, in the
case of establishments approved in accordance with Council
Decision 95/408/EC of 22 June 1995 on the conditions for
drawing up, for an interim period, provisional lists of third-
country establishments from which Member States are autho-
rised to import certain products of animal origin, fishery
products or live bivalve molluscs, from an establishment
which has undergone either a Community or a national
inspection.’

5. Article 12(9) is deleted.

6. Article 15(5) is deleted.

‘1a.
This Regulation shall apply in addition to Regulation
(EC) No 882/2004 of the European Parliament and of the
Council 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 (*).

(*) OJ L 165, 30.4.2004, p. 1.’

2.

In Article 2:

(a)

in paragraph 1, subparagraphs (a), (b), (d) and (e) are
deleted;

7.

In Article 16, the following paragraph is inserted:

and

‘4
Detailed rules for the introduction of products of ani-
mal origin for the supply of the crew and passengers of inter-
national means of transport, and for products of animal ori-
gin ordered remotely (for example, by mail, by telephone or
via the internet) and delivered to the consumer, shall be
laid down in accordance with Article 25 of Regulation (EC)
No 882/2004.’

8. Article 21 is deleted.

9. Article 23 is deleted.

(b)

the following subparagraph is added to paragraph 2:

‘(b)(a) Regulation (EC) No 882/2004.’

3.

In Article 3:

(a) paragraph 1 is replaced by the following:

10. In Article 24(1),

‘in accordance with
Article 17(2)(a) and (b)’ is replaced by ‘in accordance with
Article 17’.

second indent,

The competent authorities shall approve establish-
specified in

‘1.
ments when,
Article 31(2) of Regulation (EC) No 882/2004’;

and in the manner,

Article 59

Amendment of Directive 2000/29/EC

(b) paragraphs 4(a) and (b) and paragraph 6 are deleted.

and

The following Article is inserted in Directive 2000/29/EC:

4. Article 9 is deleted.

‘Article 27a

5. Article 10 is replaced with the following:

For the purpose of this Directive and without prejudice to
Article 21 thereof, Articles 41 to 46 of Regulation (EC)
No 882/2004 of the European Parliament and of the Council of
29 April 2004 on official controls performed to ensure the veri-
fication of compliance with feed and food law, animal health and
animal welfare rules (*) shall apply, as appropriate.

(*) OJ L 165, 30.4.2004, p. 1.’

‘Article 10

To ensure the uniform application of the principles and con-
ditions
laid down in Article 11 of Regulation (EC)
No 178/2002 and Title VI, Chapter II, of Regulation (EC)
No 882/2004 the procedures laid down in this Chapter shall
apply.’

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6.

In Article 11:

(a) paragraph 2 is replaced by the following:

However, the implementing rules adopted on the basis of
2.
those acts, in particular those referred to in Annex VIII, shall
remain in force in so far as they are not in contradiction with this
Regulation, pending the adoption of the necessary provisions on
the basis of this Regulation.

‘2
A third country shall appear on such lists only if a
Community control in that country has taken place and
demonstrates that the competent authority provides
appropriate guarantees as specified in Article 48(3) of
Regulation (EC) No 882/2004. However, a third coun-
try may appear on such lists without a Community con-
trol having taken place if:

risk

determined

the
accordance with
Article 46(3)(a) of Regulation (EC) No 882/2004
does not warrant it;

in

and

(a)

(b)

Reference to the repealed acts shall be construed as refer-

3.
ences to this Regulation.

TITLE IX

GENERAL PROVISIONS

Article 62

Committee procedure

it is determined, when deciding to add a particular
third country to a list in accordance with para-
graph 1, that other information indicates that the
competent
the necessary
guarantees.’

authority provides

1.
The Commission shall be assisted by the Standing Commit-
tee on the Food Chain and Animal Health instituted by Article 58
of Regulation (EC) No 178/2002 or, where dealing with matters
mainly relating to plant health, by the Standing Committee on
plant health set up by Council Decision 76/894/EEC (1).

(b)

in paragraph 4, the introduction is replaced by the
following:

2. Where reference is made to this paragraph, Articles 3 and 7
of Decision 1999/468/EC shall apply, having regard to the pro-
visions of Article 8 thereof.

‘4 When drawing up or updating lists, particular
account shall be taken of the criteria listed in Articles 46
and 48(3) of Regulation (EC) No 882/2004. Regard shall
also be had to.’;

3. 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.

and

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

(c)

subparagraphs (b) to (h) of paragraph 4 are deleted.

4.

The Committee shall adopt its Rules of Procedure.

7. Article 14(2)(b) is replaced by the following:

‘(b) any specific import conditions established in accordance
with Article 48 of Regulation (EC) No 882/2004.’

8. Article 18(17) to (20) are deleted.

Article 63

Implementing and transitional measures

1.
Implementing and transitional measures necessary to ensure
the uniform application of this Regulation may be laid down in
accordance with the procedure referred to in Article 62(3).

Article 61

Repeal of Community acts

This applies in particular to:

Directives

70/373/EEC,

1.
89/397/EEC,
93/99/EEC and 95/53/EC and Decisions 93/383/EEC, 98/728/EC
and 1999/313/EC are hereby repealed with effect from 1 Janu-
ary 2006. Directive 85/73/EEC is hereby repealed with effect from
1 January 2008.

85/591/EEC,

(a)

the delegation of control tasks to control bodies referred to
in Article 5, where these control bodies were already in
operation before the entry into force of this Regulation;

(1) OJ L 340, 9.12.1976, p. 25.

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(b) any modification with regard to the standards referred to in

Article 65

Article 12(2);

Report to the European Parliament and the Council

(c)

the non-compliance referred to in Article 28 which gives rise
to expenses arising from additional official controls;

The Commission shall, not later than 20 May 2007, submit

1.
a report to the European Parliament and the Council.

(d) expenditure incurred pursuant to Article 54;

2.
The report shall, in particular, review the experience gained
from the application of this Regulation and consider in particular
the following issues:

(e)

rules on microbiological, physical and/or chemical analysis in
official controls, in particular in case of suspicion of risk and
including the surveillance of the safety of products imported
from third countries;

(f) defining what feed is to be considered as feed of animal ori-

gin for the purpose of this Regulation.

2.
In order to take account of the specificity of Regulations
(EEC) No 2092/91, (EEC) No 2081/92 and (EEC) No 2082/92,
specific measures to be adopted in accordance with the procedure
referred to in Article 62(3) may provide for the necessary dero-
gations from and adjustments to the rules laid down in this
Regulation.

(a)

re-evaluating the scope, in relation to animal health and ani-
mal welfare;

(b) ensuring that other sectors contribute to the financing of offi-
cial controls by extending the list of activities referred to in
Annex IV, section A and in Annex V, section A, and taking
into account in particular the impact of the Community feed
and food hygiene legislation after its adoption;

(c)

setting updated minimum rates for fees referred to in
Annex IV, section B and in Annex V, section B, taking into
account in particular risk factors.

The Commission shall, if appropriate, accompany the report

3
with relevant proposals.

Article 64

Amendment of Annexes and references to European
standards

Article 66

Community financial support

1.

The appropriations required for:

In accordance with the procedure referred to in Article 62(3):

(a)

the travel and subsistence expenses that Member States’
experts incur as a result of the Commission appointing them
to assist its experts as provided for in Articles 45(1) and 46(1);

1.

the Annexes to this Regulation may be updated, except for
Annex I, Annex IV and Annex V, without prejudice to
Article 27(3), in particular in order to take account of admin-
istrative changes and scientific and/or technological progress;

(b)

the training of control staff provided for in Article 51;

(c)

the financing of other measures necessary to ensure the
application of this Regulation,

2.

the references to the European standards referred to in this
Regulation may be updated in the event that CEN amends
these references.

shall be authorised each year in the framework of the budgetary
procedure.

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The measures referred to in paragraph 1(c) shall include in
2.
particular the organisation of conferences, the establishment of
databases, the publication of information, the organisation of
studies and the organisation of meetings to prepare the sessions
of the Standing Committee on the Food Chain and Animal Health.

TITLE X

FINAL PROVISION

Article 67

Entry into force

Technical support and a financial contribution from the
3.
Community for the organisation of the activities referred to in
Article 50 may be granted within the limits of the human and
financial resources available to the Commission.

This Regulation shall enter into force on the 20th day following
that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2006.

However, Articles 27 and 28 shall apply from 1 January 2007.

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

Done at Strasbourg, 29 April 2004.

For the European Parliament
The President
P. COX

For the Council
The President
M. McDOWELL

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ANNEX I

TERRITORIES REFERRED TO IN ARTICLE 2(15)

The territory of the Kingdom of Belgium

The territory of the Kingdom of Denmark with the exception of the Faroe Islands and Greenland

The territory of the Federal Republic of Germany

The territory of the Kingdom of Spain with the exception of Ceuta and Melilla

The territory of the Hellenic Republic

The territory of the French Republic

The territory of Ireland

The territory of the Italian Republic

The territory of the Grand Duchy of Luxembourg

1.

2.

3.

4.

5.

6.

7.

8.

9.

10. The territory of the Kingdom of the Netherlands in Europe

11. The territory of the Portuguese Republic

12. The territory of the United Kingdom of Great Britain and Northern Ireland

13. The territory of the Republic of Austria

14. The territory of the Republic of Finland

15. The territory of the Kingdom of Sweden

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ANNEX II

COMPETENT AUTHORITIES

CHAPTER I: SUBJECT MATTER FOR THE TRAINING OF STAFF PERFORMING OFFICIAL CONTROLS

1. Different control techniques, such as auditing, sampling and inspection

2.

Control procedures

3.

Feed and food law

4.

The different stages of production, processing and distribution, and the possible risks for human health, and where
appropriate for the health of animals and plants and for the environment

5. Assessment of non-compliance with feed and food law

6. Hazards in animal feed and food production

7.

The evaluation of the application of HACCP procedures

8. Management systems such as quality assurance programmes that feed and food businesses operate and their assessment

in so far as these are relevant for feed or food law requirements

9. Official certification systems

10. Contingency arrangements for emergencies, including communication between Member States and the Commission

11. Legal proceedings and implications of official controls

12. Examination of written, documentary material and other records, including those related to proficiency testing,
accreditation and risk assessment, which may be relevant to the assessment of compliance with feed or food law; this
may include financial and commercial aspects

13. Any other area, including animal health and animal welfare, necessary to ensure that official controls are carried out

in accordance with this Regulation.

CHAPTER II: SUBJECT AREAS FOR CONTROL PROCEDURES

1.

2.

The organisation of the competent authority and the relationship between central competent authorities and authorities
to which they have delegated tasks to carry out official controls

The relationship between competent authorities and control bodies to which they have delegated tasks related to official
controls

3. A statement on the objectives to be achieved

4.

Tasks, responsibilities and duties of staff

5.

Sampling procedures, control methods and techniques, interpretation of results and consequent decisions

6. Monitoring and surveillance programmes

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7. Mutual assistance in the event that official controls require more than one Member State to take action

8. Action to be taken following official controls

9.

Cooperation with other services or departments that may have relevant responsibilities

10. Verification of the appropriateness of methods of sampling, methods of analysis and detection tests

11. Any other activity or information required for the effective functioning of the official controls.

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ANNEX III

CHARACTERISATION OF METHODS OF ANALYSIS

1. Methods of analysis should be characterised by the following criteria:

(a)

accuracy;

(b)

applicability (matrix and concentration range);

(c)

limit of detection;

(d)

limit of determination;

(e)

precision;

(f)

repeatability;

(g)

reproducibility;

(h)

recovery;

(i)

selectivity;

(j)

sensitivity;

(k)

linearity;

(l) measurement uncertainty;

(m) other criteria that may be selected as required.

2.

The precision values referred to in 1(e) shall either be obtained from a collaborative trial which has been conducted in
accordance with an internationally recognised protocol on collaborative trials (e.g. ISO 5725:1994 or the IUPAC
International Harmonised Protocol) or, where performance criteria for analytical methods have been established, be
based on criteria compliance tests. The repeatability and reproducibility values shall be expressed in an internationally
recognised form (e.g. the 95 % confidence intervals as defined by ISO 5725:1994 or IUPAC). The results from the
collaborative trial shall be published or freely available.

3. Methods of analysis which are applicable uniformly to various groups of commodities should be given preference over

methods which apply only to individual commodities.

4.

In situations where methods of analysis can only be validated within a single laboratory then they should be validated
in accordance with e.g. IUPAC Harmonised Guidelines, or where performance criteria for analytical methods have been
established, be based on criteria compliance tests.

5. Methods of analysis adopted under this Regulation should be edited in the standard layout for methods of analysis

recommended by the ISO.

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ANNEX IV

ACTIVITIES AND MINIMUM RATES FOR FEES OR CHARGES RELATED TO
OFFICIAL CONTROLS IN RELATION TO COMMUNITY ESTABLISHMENTS

SECTION A: ACTIVITIES

1.

The activities covered by Directives 89/662/EEC, 90/425/EEC, 93/119/EC and 96/23/EC for which Member States are
currently collecting fees pursuant to Directive 85/73/EEC

2.

The approval of feed establishments

SECTION B: MINIMUM RATES

Member States shall collect for controls relating to the following list of products, at least the corresponding minimum rates
for fees or charges.

CHAPTER I

Minimum rates for fees or charges applicable to slaughter inspection

(a) beef meat

— adult bovine animals:

— young bovine animals:

(b) solipeds and equidae:

(c) pigmeat: animals of a carcase weight

— of less than 25 kg:

— equal to or greater than 25 kg:

5 EUR/animal

2 EUR/animal

3 EUR/animal

0,5 EUR/animal

1 EUR/animal

(d) sheepmeat and goatmeat: animals of a carcase weight

— of less than 12 kg:

— equal to or greater than 12 kg:

0,15 EUR/animal

0,25 EUR/animal

(e) poultrymeat

— poultry of genus Gallus and guinea fowl:

0,005 EUR/animal

— ducks and geese:

— turkeys:

— farmed rabbit meat:

0,01 EUR/animal

0,025 EUR/animal

0,005 EUR/animal.

CHAPTER II

Minimum rates for fees or charges applicable to cutting plants controls

Per tonne of meat:

— beef, veal, pig, solipeds/equidae, sheep and goatmeat:

2 EUR

— poultry and farmed rabbit meat:

— farmed and wild game meat:

— small game birds and ground game:

— ratites meat (ostrich, emu, nandou):

— boars and ruminants:

1,5 EUR

EUR 1,5

EUR 3

EUR 2.

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Minimum rates for fees or charges applicable to game processing houses

CHAPTER III

(a) small game birds:

0,005 EUR/animal

(b) small ground game:

0,01 EUR/animal

(c) ratites:

0,5 EUR/animal

(d) land mammals:

— boar:

— ruminants:

1,5 EUR/animal

0,5 EUR/animal

CHAPTER IV

Minimum rates for fees or charges applicable to milk production

— EUR 1 per 30 tonnes

and

— EUR 0,5 per tonne, thereafter.

Minimum rates for fees or charges applicable to the producing and placing on the market of fishery products
and aquaculture products

CHAPTER V

(a)

first placing on the market of fishery and aquaculture products:

— 1 EUR/tonne for the first 50 tonnes in the month;

— 0,5 EUR/tonne thereafter.

(b)

first sale in fish market

— 0,5 EUR/tonne for the first 50 tonnes in the month;

— 0,25 EUR/tonne thereafter.

(c)

first sale in case of lack of or insufficient gradation for freshness and/or size in accordance with Regulations (EEC)
No 103/76 and (EEC) No 104/76:

— 1 EUR/tonne for the first 50 tonnes in the month;

— 0,5 EUR/tonne thereafter.

The fees collected on the species referred to in Annex II to Commission Regulation (EEC) No 3703/85 must not exceed EUR
50 per consignment.

Member States will collect 0,5 EUR/tonne for the processing of fishery and aquaculture products.

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ANNEX V

ACTIVITIES AND MINIMUM RATES FOR FEES OR CHARGES RELATED TO THE
OFFICIAL CONTROLS OF GOODS AND LIVE ANIMALS INTRODUCED INTO
THE COMMUNITY

SECTION A: ACTIVITIES OR CONTROLS

The activities covered by Directives 97/78/EC and 91/496/EEC for which Member States are currently collecting fees pur-
suant to Directive 85/73/EEC.

SECTION B: FEES OR CHARGES

CHAPTER I

Fees applicable to imported meat

The minimum fee rates for the official control on the import of a consignment of meat are fixed at:

— EUR 55 per consignment, up to six tonnes,

and

— EUR 9 per tonne, up to 46 tonnes, thereafter,

or

— EUR 420 per consignment, over 46 tonnes.

CHAPTER II

Fees applicable to imported fishery products

1.

The minimum fee for the official control on the import of a consignment of fishery products is fixed at:

— EUR 55 per consignment, up to six tonnes,

and

— EUR 9 per tonne, up to 46 tonnes, thereafter,

or

— EUR 420 per consignment, over 46 tonnes.

2.

The above amount for the official control on the import of a consignment of fishery products, transported as break bulk
shipment, shall be:

— EUR 600 per vessel, with a cargo of fishery products up to 500 tonnes,

— EUR 1 200 per vessel, with a cargo of fishery products up to 1 000 tonnes,

— EUR 2 400 per vessel, with a cargo of fishery products up to 2 000 tonnes,

— EUR 3 600 per vessel, with a cargo of fishery products of more than 2 000 tonnes.

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3.

In the case of fishery products caught in their natural environment directly landed by a fishing vessel flying the flag of
a third country, the provisions laid down in Annex IV, Section B, Chapter V, point (a) shall apply.

Fees or charges applicable to meat products, poultrymeat, wild game meat, rabbit meat, farmed game meat,
by-products and feed of animal origin

CHAPTER III

1.

The minimum fee for the official control on the import of a consignment of products of animal origin other than those
mentioned in Chapters I and II or a consignment of by-products of animal origin or a consignment of feed, is fixed at:

— EUR 55 per consignment, up to six tonnes,

and

— EUR 9 per tonne, up to 46 tonnes, thereafter,

or

— EUR 420 per consignment, over 46 tonnes.

2.

The above amount for the official control on the import of a consignment of products of animal origin other than those
mentioned in Chapters I and II, a consignment of by-products of animal origin or a consignment of feed transported
as break bulk shipment, shall be:

— EUR 600 per vessel, with a cargo of products up to 500 tonnes,

— EUR 1 200 per vessel, with a cargo of products up to 1 000 tonnes,

— EUR 2 400 per vessel, with a cargo of products up to 2 000 tonnes,

— EUR 3 600 per vessel, with a cargo products of more than 2 000 tonnes.

Fees applicable to transit through the community of goods and live animals

CHAPTER IV

The amount of fees or charges for the official control on the transit of goods and live animals through the Community is
fixed at a minimum level of EUR 30, increased by EUR 20 per quarter of an hour for every member of staff involved in the
controls.

CHAPTER V

Fees applicable to imported live animals

1.

The fee for the official control on the import of a consignment of live animals is fixed:

(a)

for bovine animals, equidae, pigs, sheep, goats, poultry, rabbits and small game birds or ground game and the fol-
lowing land mammals: wild boar and ruminants, at:

— EUR 55 per consignment, up to six tonnes,

and

— EUR 9 per tonne, up to 46 tonnes, thereafter,

or

— EUR 420 per consignment, over 46 tonnes,

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(b)

for animals of other species at the actual cost of inspection expressed either per animal or per tonne imported, at:

— EUR 55 per consignment, up to 46 tonnes,

or

— EUR 420 per consignment, over 46 tonnes,

it being understood that this minimum does not apply to imports of species referred to in Commission
Decision 92/432/EEC.

2. At the request of a Member State, accompanied by appropriate supporting documents and in accordance with the
procedure laid down in Article 18 of Directive 89/662/EEC, a lower level of fees may be applied to imports from certain
third countries.

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ANNEX VI

CRITERIA TO BE TAKEN INTO CONSIDERATION FOR THE CALCULATION OF
FEES

1.

2.

The salaries of the staff involved in the official controls

The costs for the staff involved in the official controls, including facilities, tools, equipment, training, travel and
associated costs

3.

The laboratory analysis and sampling costs

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ANNEX VII

COMMUNITY REFERENCE LABORATORIES

I.

Community reference laboratories for feed and food

1.

Community reference laboratory for milk and milk products

Afssa-Lerhqa

F-94700 Maisons-Alfort

2.

Community reference laboratories for the analysis and testing of zoonoses (salmonella)

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

3720 BA Bilthoven

The Netherlands

3.

Community reference laboratory for the monitoring of marine biotoxins

Ministerio de Sanidad y Consumo

Vigo

Spain

4.

Community reference laboratory for monitoring the viral and bacteriological contamination of bivalve molluscs

The laboratory of the Centre for Environment, Fisheries and Aquaculture Science, Weymouth, United Kingdom.

5.

Community reference laboratories for residues

(a)

For the residues listed in Annex I, Group A 1, 2, 3, 4, Group B 2 (d) and Group B 3 (d) to Council Directive
96/23/EC

Rijksinstituut voor Volksgezondheid en Milieu (RIVM)

3720 BA Bithoven

The Netherlands

(b)

For the residues listed in Annex I, Group B 1 and B 3 (e) to Council Directive 96/23/EC and carbadox and
olaquidonx

Laboratoires d’études et de recherches sur les médicaments vétérinaires et les désinfectants

AFSSA - Site de Fougères

BP 90203

France

(c)

For the residues listed in Annex I, Group A 5 and Group B 2 (a), (b), (e) to Council Directive 96/23/EC

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)

Postfach 140162

D-53056 Bonn

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(d)

For the residues listed in Annex I, Group B 2 (c) and Group B 3 (a), (b), (c) to Council Directive 96/23/EC

Instituto Superiore di Sanità

I-00161 -Roma

6.

Community reference laboratory for transmissible spongiform encephalopathies (TSEs)

The laboratory referred to in Annex X, Chapter B of Regulation (EC) No 999/2001

7.

Community reference laboratory for additives for use in animal nutrition

The laboratory referred to in Annex II of 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)

8.

Community reference laboratory for genetically modified organisms (GMOs)

The laboratory referred to in the Annex to Regulation (EC) No 1829/2003 of the European Parliament and of the
Council of 22 September 2003 on genetically modified food and feed (2).

9.

Community reference laboratory for material intended to come into contact with foodstuffs

The Joint Research Centre of the Commission

II. Community reference laboratories for animal health

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

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ANNEX VIII

IMPLEMENTING RULES THAT REMAIN IN FORCE PURSUANT TO ARTICLE 61

1.

Implementing rules based on Directive 70/373/EEC on the introduction of Community methods of sampling and
analysis for the official control of feedingstuffs

(a)

First Commission Directive 71/250/EEC of 15 June 1971 establishing Community methods of analysis for the offi-
cial control of feedingstuffs (1)

(b)

Second Commission Directive 71/393/EEC of 18 November 1971 establishing Community methods of analysis
for the official control of feedingstuffs (2)

(c) Third Commission Directive 72/199/EEC of 27 April 1972 establishing Community methods of analysis for the

official control of feedingstuffs (3)

(d)

Fourth Commission Directive 73/46/EEC of 5 December 1972 establishing Community methods of analysis for
the official control of feedingstuffs (4)

(e)

First Commission Directive 76/371/EEC of 1 March 1976 establishing Community methods of sampling for the
official control of feedingstuffs (5)

(f)

Seventh Commission Directive 76/372/EEC of 1 March 1976 establishing Community methods of analysis for
the official control of feedingstuffs (6)

(g)

Eighth Commission Directive 78/633/EEC of 15 June 1978 establishing Community methods of analysis for the
official control of feedingstuffs (7)

(h) Ninth Commission Directive 81/715/EEC of 31 July 1981 establishing Community methods of analysis for the

official control of feedingstuffs (8)

(i)

(j)

Tenth Commission Directive 84/425/EEC of 25 July 1984 establishing Community methods of analysis for the
official control of feedingstuffs (9)

Eleventh Commission Directive 93/70/EEC of 28 July 1993 establishing Community methods of analysis for the
official control of feedingstuffs (10)

(k) Twelfth Commission Directive 93/117/EC of 17 December 1993 establishing Community methods of analysis

for the official control of feedingstuffs (11)

(l)

Commission Directive 98/64/EC of 3 September 1998 establishing Community methods of analysis for the deter-
mination of amino acids, crude oils and fats, and olaquindox in feedingstuffs (12)

(1) OJ L 155, 12.7.1971, p. 13. Directive as last amended by Commission Directive 1999/27/EC (OJ L 118, 6.5.1999, p. 36).
(2) OJ L 279, 20.12.1971, p. 7. Directive as last amended by Commission Directive 98/64/EC (OJ L 257, 19.9.1998, p. 14).
(3) OJ L 123, 29.5.1972, p. 6. Directive as last amended by Commission Directive 1999/79/EC (OJ L 209, 7.8.1999, p. 23).
(4) OJ L 83, 30.3.1973, p. 21. Directive as last amended by Commission Directive 1999/27/EC.
(5) OJ L 102, 15.4.1976, p. 1.
(6) OJ L 102, 15.4.1976, p. 8. Directive as last amended by Commission Directive 94/14/EC (OJ L 94, 13.4.1994, p. 30).
(7) OJ L 206, 29.7.1978, p. 43. Directive as last amended by Commission Directive 84/4/EEC (OJ L 15, 18.1.1984, p. 28).
(8) OJ L 257, 10.9.1981, p. 38.
(9) OJ L 238, 6.9.1984, p. 34.
(10) OJ L 234, 17.9.1993, p. 17.
(11) OJ L 329, 30.12.1993, p. 54.
(12) OJ L 257, 19.9.1998, p. 14.

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(m) Commission Directive 2003/126/EC of 23 December 2003 on the analytical method for the determination of con-

stituents of animal origin for the official control of foodstuffs (1)

(n) Commission Directive 1999/27/EC of 20 April 1999 establishing Community methods of analysis for the deter-

mination of amprolium, diclazuril and carbadox in feedingstuffs (2)

(o) Commission Directive 1999/76/EC of 23 July 1999 establishing a Community method of analysis for the deter-

mination of lasalocid sodium in feedingstuffs (3)

(p) Commission Directive 2000/45/EC of 6 July 2000 establishing Community methods of analysis for the determi-

nation of vitamin A, vitamin E and tryptophan in feedingstuffs (4)

(q) Directive 2002/70/EC of 26 July 2002 establishing requirements for the determination of levels of dioxins and

dioxin-like PCBs in feedingstuffs (5)

2.

Implementing rules based on Directive 95/53/EC of 25 October 1995 fixing the principles governing the organisation
of official inspections in the field of animal nutrition

Commission Directive 98/68/EC of 10 September 1998 laying down the standard document referred to in Article 9(1)
of Council Directive 95/53/EC and certain rules for checks at the introduction into the Community of feedingstuffs
from third countries (6).

(1) OJ L 339, 24.12.2003, p. 78.
(2) OJ L 118, 6.5.1999, p. 36.
(3) OJ L 207, 6.8.1999, p. 13.
(4) OJ L 174, 13.7.2000, p. 32.
(5) OJ L 209, 6.8.2002, p. 15.
(6) OJ L 261, 24.9.1998, p. 32.