Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additivesText with EEA relevance
Date: 2005-03-04
Institutions: European Commission
Subjects: animal nutrition, food additive, food inspection, market approval, research body, research method

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Official Journal of the European Union

5.3.2005

COMMISSION REGULATION (EC) No 378/2005

of 4 March 2005

on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European
Parliament and of the Council as regards the duties and tasks of the Community Reference
Laboratory concerning applications for authorisations of feed additives

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty
Community,

establishing the European

the
Having regard to Regulation (EC) No 1831/2003 of
European Parliament and of
the Council of 22 September
2003 on additives for use in animal nutrition (1), and in
particular the first subparagraph of Article 7(4) and the third
subparagraph of Article 21 thereof,

Whereas:

(1)

(2)

(3)

(4)

Regulation (EC) No 1831/2003 lays down rules for the
placing on the market and use of feed additives in animal
nutrition. It provides that any person seeking an author-
isation for a feed additive or a new use of a feed additive
is to submit an application for authorisation to the
Commission in accordance with that Regulation (the
application).

for

provides

(EC) No

1831/2003

Regulation
a
Community reference laboratory (the CRL) to carry out
certain duties and tasks set out in Annex II to that Regu-
lation. It also provides that the Joint Research Centre of
the Commission is to be the CRL and that it may be
assisted by a consortium of national reference labora-
tories to perform the duties and tasks set out in that
Annex.

In accordance with Regulation (EC) No 1831/2003, it is
implementing
necessary to adopt detailed rules
Annex
including practical
conditions for the duties and tasks of the CRL and to
amend that Annex accordingly.

to that Regulation,

for

II

samples

the
in

to be provided in the
In addition,
application,
(EC)
No 1831/2003, should meet specific requirements in
view of the duties and tasks of the CRL.

accordance with Regulation

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

(6)

(7)

(8)

(9)

(10)

(11)

(12)

is necessary to establish a precise timing for the
It
delivery of the evaluation report from the CRL to the
European Food Safety Authority (the Authority)
in
order to ensure that the procedures provided for in Regu-
lation (EC) No 1831/2003 can be met.

The CRL should be authorised to charge a fee to
applicants towards the costs of supporting the duties
and tasks of the CRL and the consortium of national
reference laboratories.

the
National reference laboratories should be part of
consortium of
laboratories assisting the CRL only if
they meet specific requirements in order to properly
perform the duties and tasks laid down in Regulation
be
(EC) No 1831/2003. Member
permitted to apply to the Commission for the desig-
nation of such laboratories.

should

States

it

to ensure the effective functioning of

the
In order
is necessary to appoint a rapporteur
consortium,
laboratory to carry out an initial assessment of
the
method(s) of analysis of each individual application and
to establish clearly the duties and tasks of the rapporteur
laboratories and the other laboratories participating in
the consortium.

It is necessary to establish special procedures for the
cases where the data in the application are insufficient
concerning testing or validation of
the method(s) of
analysis.

In the interests of stability and efficacy and also in order
it is necessary to
to make the consortium operational,
appoint the national reference laboratories participating
in the consortium.

The relations between the members of the consortium
should be defined by contract between them.
In this
context the CRL may develop guidance for applicants
and for the laboratories participating in the consortium.

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

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(f)

(g)

HAS ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject matter and scope

This Regulation lays down detailed rules for the implementation
of Regulation (EC) No 1831/2003 as regards:

(a) applications for authorisation of a feed additive or for a new
use of a feed additive as provided for in Article 4(1) of that
Regulation (the application); and

a

feedingstuff

‘feed test material’ means
sample or
premixture sample with or without the inclusion of the
feed additive which is the object of the application, to be
used for experimental studies on the method of analysis for
the feed additive in feedingstuffs
the determination of
and/or premixtures;

‘food test material’ means a food sample derived from an
animal that has been fed with feedingstuffs with or without
the inclusion of the feed additive which is the object of the
to be used for experimental studies on the
application,
method of analysis
the feed
additive in the residue(s) or metabolite(s).

the determination of

for

Article 3

Reference samples

(b) the duties

and tasks of

the Community Reference

Laboratory (the CRL).

Any person making an application shall send reference

1.
samples:

Article 2

Definitions

(a)

in a form in which the feed additive is intended to be placed
on the market by the applicant; or

For the purposes of this Regulation, the following definitions
shall apply:

(b) that are suitable to be converted easily in a form in which
the feed additive is intended to be placed on the market by
the applicant.

(a)

‘reference sample’ means a representative sample of the feed
additive, as referred to in Article 7(3)(f) of Regulation (EC)
No 1831/2003, which is the object of an application;

(b) ‘method of analysis’ means the procedure for the determi-
nation of the active substance(s) of the feed additive in
its residue(s) or
feedingstuffs, and where appropriate, of
metabolite(s)
in food, as referred to in Article 7(3)(c) of
the Regulation (EC) No 1831/2003;

(c)

‘evaluation of the method of analysis’ means the thorough
assessment of the protocol of the method of analysis as
described in the application,
if appropriate,
literature research but not necessarily any experimental
work;

including,

(d) ‘testing of a method of analysis’ means the application of
the method of analysis in a laboratory and comparison of
results with those described in the application;

2.
The three reference samples shall be accompanied by a
written statement by the applicant that the fee provided for in
Article 4(1) has been paid.

The applicant shall supply feed and/or food test materials

3.
related to the samples if requested by the CRL.

Article 4

Fees

The CRL shall charge the applicant a fee of EUR 3 000 for

1.
each application (the fee).

2.
The CRL shall use the fees towards supporting the costs of
the duties and tasks as set out in Annex II to Regulation (EC)
No 1831/2003, and in particular those referred to in 2.1, 2.2
and 2.3 of that Annex.

(e)

‘validation of a method of analysis’ means the process of
proving that a method of analysis is fit for the intended
purpose, by
to
an intercomparison study
ISO 5725-1 to 6 or other
internationally harmonised
guidelines for validation of methods by intercomparison
study;

according

3.
The amount of the fee mentioned in paragraph 1 may be
adapted once a year in accordance with the procedure referred
to in Article 22(2) of Regulation (EC) No 1831/2003. The
adaptation shall
the experience gained
during the operation of this Regulation and in particular the
possibility of fixing different fees for different types of appli-
cations.

take into account

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Article 5

Evaluation reports by the CRL

1.
to the
The CRL shall submit a full evaluation report
European Food Safety Authority (the Authority) for each appli-
cation within three months from the date of receipt of a valid
application as referred to in Article 8(1) of Regulation (EC)
if the
No 1831/2003 and the payment of the fee. However,
it may
CRL considers that the application is very complex,
extend that period by an additional month. The CRL shall
inform the Commission,
the Authority and the applicant
where the period is extended.

If

in the consortium.

it considers
laboratories to take part
that such laboratories comply with the requirements set out
in Annex I, the Commission shall amend the list in Annex II
in accordance with the procedure referred to in Article 22(2) of
Regulation (EC) No 1831/2003. The same procedure shall apply
if a Member State wishes to withdraw one of
its national
reference laboratories from the consortium. The contractual
arrangements between the members of the consortium shall
be adjusted to reflect any changes to the consortium.

Article 7

Rapporteur laboratories

The evaluation report provided for in paragraph 1 shall

2.
include in particular:

The CRL shall appoint one laboratory to act as rapporteur

1.
laboratory for each application (the rapporteur laboratory).

(a) an evaluation indicating if the methods of analysis in the
data submitted in the application are suitable to be used for
official controls;

However, the CRL may also act as rapporteur laboratory for
applications.

(b) an indication if testing of a method of analysis is considered

necessary;

2. When appointing a rapporteur laboratory, the CRL shall
take into account the expertise, experience and workload of the
laboratory.

(c) an indication if a validation of a method of analysis by an

intercomparison study is considered necessary.

3.
The laboratories shall send comments to the rapporteur
laboratory within 20 days from the date of receipt of the initial
evaluation report provided for in Article 8(a).

CHAPTER II

NATIONAL REFERENCE LABORATORIES

Article 6

National reference laboratories

The CRL shall be assisted by a consortium of national
1.
reference laboratories
the duties and
(the consortium)
tasks set out in 2.2, 2.4 and 3 of Annex II to Regulation
(EC) No 1831/2003.

for

2.
The consortium is open to national reference laboratories
which comply with the requirements set out in Annex I. The
laboratories listed in Annex II are hereby appointed national
reference laboratories to take part in the consortium.

3.
The members of the consortium, including the CRL, shall
enter into a contract to define the relations between them,
particularly in financial matters.
the contract
may provide that the CRL is to distribute a share of the fees
it receives to the other members of the consortium. Subject to
this contract, the CRL may issue guidance to the members of
the consortium as provided for in Article 12.

In particular,

Any Member

4.
to the
Commission for the designation of further national reference

State may

requests

submit

Article 8

Duties and tasks of rapporteur laboratories

The rapporteur laboratories shall be responsible for:

(a) drafting an initial evaluation report concerning the data
for
submitted in each application and submitting it
comments to the other laboratories;

(b) compiling the comments received from the other labora-

tories and preparing a revised evaluation report;

(c) submitting the revised evaluation report

to the CRL in
sufficient time to allow the CRL to submit its full evaluation
report to the Authority within the deadline referred to in
Article 5(1).

Article 9

Duties and tasks of the laboratories participating in the
consortium

1.
The laboratories participating in the consortium shall be
responsible for contributing to the initial evaluation report
prepared by the rapporteur laboratory by sending comments
to the rapporteur laboratory within 20 days of the reception
of the initial report.

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Each laboratory shall communicate

to the CRL by
2.
30 January each year an estimate of the number of applications
for which the laboratory considers itself able to carry out the
tasks of rapporteur laboratory for that year. The CRL shall make
available annually to all the laboratories a compilation of the
estimates provided.

CHAPTER III

Regulation and shall
consortium shall contribute to this annual report.

submit

it

to the Commission. The

The CRL may also organise an annual meeting with the
consortium, in view of the establishment of the annual report.

Article 12

Guidance

TESTING AND VALIDATION OF METHODS OF ANALYSIS,
REPORTING AND GUIDANCE

The CRL may establish detailed guidance for applicants

1.
concerning:

Article 10

Testing of methods of analysis and validation of methods
of analysis

The CRL shall

1.
Authority, as provided for in Article 5(2), and shall
the applicant and the Commission,
following are necessary:

indicate in its evaluation report to the
inform
the

it considers that

if

(a)

testing of methods of analysis;

(b) validation of methods of analysis.

In doing so,
the CRL shall provide the applicant with a
document describing the work to be carried out through the
consortium including a time schedule and an estimate of a
special
fee to be paid by the applicant. The applicant shall
inform the CRL about his agreement to the document within
15 days of receipt of the communication.

The CRL shall supplement the report to the Authority, as
2.
provided for in Article 5(1), with an addendum concerning the
outcome of
the procedure foreseen in
paragraph 1 within 30 days of the availability to the CRL of
the results of the testing and validation work.

the application of

Article 11

Reporting

The CRL shall be responsible for preparing an annual report on
each year’s activities carried out for the implementation of this

(a) reference samples;

(b) the testing of methods of analysis,

including in particular

criteria about when such testing may be required;

(c)

the validation of methods of analysis, including in particular
criteria about when such validation may be required.

The CRL shall establish detailed guidance for laboratories,

2.
including criteria for appointing rapporteur laboratories.

CHAPTER IV

FINAL PROVISIONS

Article 13

Amendments to Regulation (EC) No 1831/2003

to Regulation (EC)
Paragraphs 2 and 3 of Annex II
No 1831/2003 are replaced by the text in Annex III to this
Regulation.

Article 14

Entry into force

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

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

Done at Brussels, 4 March 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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Requirements for laboratories participating, as referred to in Article 8

ANNEX I

Laboratories participating in the consortium must satisfy the following minimum requirements:

(a) have been proposed as a national reference laboratory by a Member State for the purpose of taking part in the

consortium referred to in Annex II to Regulation (EC) No 1831/2003;

(b) have suitable qualified staff that are adequately trained in analytical methods used for the feed additives on which they

are involved;

(c) possess the equipment needed to carry out the analysis of feed additives, in particular the ones on which they are

carrying tasks under this Regulation;

(d) have an adequate administrative infrastructure;

(e) have sufficient data-processing capacity to produce technical reports and to enable rapid communication with the

other laboratories participating in the consortium;

(f) provide assurance that their staff respect the confidential aspects of issues, results or communications involved in the
handling of applications for authorisation submitted in accordance with Regulation (EC) No 1831/2003 and in
particular the information referred to in Article 18 of that Regulation;

(g) have sufficient knowledge of international standards and practices in laboratory work;

(h) must be accredited, or being in the process of accreditation according to international standards such as ISO 17025.

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ANNEX II

Community reference laboratory and consortium of national reference laboratories, as referred to in Article 6(2)

COMMUNITY REFERENCE LABORATORY

Joint Research Centre of the European Commission. Institute for Reference Materials and Measurements, Geel, Belgium.

NATIONAL REFERENCE LABORATORIES OF THE MEMBER STATES

Belgique/België
— Federaal Voedingslabo Tervuren (FAVV), Tervuren,
— Vlaamse Instelling voor Technogisch Onderzoek (VITO), Mol;

Česká republika
— Central Inst. Superv. Test. Agriculture, Ústřední kontrolní a zkušební ústav zemědělský (ÚKZÚZ), Praha;

Danmark
— Plantedirektoratets Laboratorium, Lyngby;

Deutschland
— Schwerpunktlabor Futtermittel des Bayerischen Landesamtes für Gesundheit und Lebensmittelsicherheit (LGL). Ober-

schleißheim;

— Landwirtschaftliche Untersuchungs- und Forschungsanstalt (LUFA) Speyer. Speyer;

— Sächsische Landesanstalt für Landwirtschaft. Fachbereich 8 — Landwirtschaftliches Untersuchungswesen. Leipzig;
— Thüringer Landesanstalt für Landwirtschaft (TLL). Abteilung Untersuchungswesen. Jena;

Eesti
— Põllumajandusuuringute Keskus (PMK), Jääkide ja saasteainete labor, Saku, Harjumaa,

— Põllumajandusuuringute Keskus (PMK), Taimse materjali analüüsi labor, Saku, Harjumaa;

España
— Laboratorio Arbitral Agroalimentario, Ministerio de Agricultura, Pesca y Alimentación, Madrid.

— Laboratori Agroalimentari, Departament d’Agricultura, Ramaderia i Pesca, Generalitat de Catalunya, Cabrils.

France
— Laboratoire de Rennes, direction générale de la concurrence, de la consommation et de la répression des fraudes

(DGCCRF), Rennes;

Ireland
— The State Laboratory, Dublin;

Italia
— Istituto Superiore di Sanità. Dipartimento di Sanità alimentare ed animale, Roma.
— Centro di referenza nazionale per la sorveglianza ed il controllo degli alimenti per gli animali (CReAA), Torino.

Κύπρος

— Feedingstuffs Analytical Laboratory, Department of Agriculture, Nicosia;

Latvija
— Valsts veterinārmedicīnas diagnostikas centrs (VVMDC), Rīga;

Lietuvos
— Nacionalinė veterinarijos laboratorija, Vilnius,

— Klaipėdos apskrities VMVT laboratorija, Klaipėda;

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Luxembourg
— Laboratoire de contrôle et d'essais — ASTA, Ettelbrück;

Magyarország
— Országos Mezőgazdasági Minősítő Intézet (OMMI) Központi Laboratórium, Budapest;

Nederland
— RIKILT- Instituut voor Voedselveiligheid, Wageningen,
— Rijkinstituut voor Volksgezondheid en Milieu (RIVM), Bilthoven;

Österreich
— Österreichische Agentur für Gesundheit und Ernährungssicherheit (AGES), Wien;

Polska
— Instytut Zootechniki w Krakowie, Krajowe Laboratorium Pasz, Lublin,
— Państwowy Instytut Weterynaryjny, Puławy;

Portugal
— Laboratório Nacional de Investigação Veterinária, Lisboa.

Slovenija
— Univerza v Ljubljani. Veterinarska fakulteta, Nacionalni veterinarski inštitut, Enota za patologijo prehrane in higieno

okolja, Ljubljana,

— Kmetijski inštitut Slovenije, Ljubljana;

Slovensko
— Skúšobné laboratórium – oddelenie analýzy krmív, Ústredný kontrolný a skúšobný ústav poľnohospodársky,

Bratislava.

Suomi/Finland
— Kasvintuotannon tarkastuskeskus/Kontrollcentralen för växtproduktion (KTTK). Vantaa/Vanda;

Sverige
— Foderavdelningen, Statens veterinärmedicinska anstalt (SVA), Uppsala.

United Kingdom
— The Laboratory of the Government Chemist, Teddington.

NATIONAL REFERENCE LABORATORIES OF EFTA COUNTRIES

Norway
— LabNett AS, Agricultural Chemistry Laboratory, Stjørdal.

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Text replacing paragraphs 2 and 3 of Annex II to Regulation (EC) No 1831/2003

ANNEX III

‘2.

For the duties and tasks set out in this Annex, the CRL may be assisted by a consortium of national reference
laboratories.

The CRL shall be responsible for:

2.1. the reception, storage and maintenance of the samples of the feed additive sent by the applicant as provided for in

Article 7(3)(f);

2.2. evaluating the method of analysis of the feed additive, and of other relevant methods of analysis related to it, on the
basis of the data provided in the application for authorisation of the feed additive as regards its suitability for official
control in accordance with the requirements of the implementing rules referred to in Article 7(4) and (5) and the
guidance of the Authority referred to in Article 7(6);

2.3. submitting a full evaluation report to the Authority on the results of the duties and tasks referred to in this Annex;

2.4. where necessary, the testing of the method(s) of analysis.

3.

4.

The CRL shall be responsible for coordination of the validation of the method(s) of analysis of the additive, in
accordance with the procedure provided for in Article 10 of Regulation (EC) No 378/2005 (*). This task may involve
the preparation of food or feed test material.

The CRL shall provide scientific and technical assistance to the Commission, especially in cases where Member States
contest the results of analyses related to the duties and tasks referred to in this Annex, without prejudice to any role
defined for it under Articles 11 and 32 of Regulation (EC) No 882/2004 of the European Parliament and of the
Council (**).

5. On request by the Commission, the CRL may also be responsible for conducting special analytical or other related
studies in a manner similar to the duties and tasks referred to in point 2. This may be the case, in particular, for
existing products notified under Article 10 and included in the Register and for the period until an application for
authorisation under Article 10(2) is submitted in accordance with Article 10(2).

6.

The CRL shall be responsible for the overall coordination of the consortium of national reference laboratories. The
CRL shall ensure that the relevant data concerning the applications are made available to the laboratories.

7. Without prejudice to the responsibilities of the Community reference laboratories laid down in Article 32 of
Regulation (EC) No 882/2004, the CRL may create and maintain a database of methods of analysis available for
control of feed additives and make it available to official control
laboratories from Member States and other
interested parties.

(*) OJ L 59, 5.3.2005, p. 8.
(**) OJ L 165, 30.4.2004, p. 1. Corrigendum OJ L 191, 28.5.2004, p. 1.’