Guide to the compilation of a technical file on applications to designate fertilizers ‘EC fertilizer’ pursuant to Regulation (EC) No 2003/2003   (Text with EEA relevance)
Date: 2005-10-08
Institutions: European Commission
Subjects: EC conformity marking, European standard, fertiliser, labelling, quality standard, safety standard

C 250/2

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Official Journal of the European Union

8.10.2005

Guide to the compilation of a technical file on applications to designate fertilizers ‘EC fertilizer’
pursuant to Regulation (EC) No 2003/2003

(2005/C 250/02)

(Text with EEA relevance)

INTRODUCTORY NOTE

This guide is intended to help applicants wishing to register a
new fertilizer for inclusion in the list of designated EC fertili-
zers.

Although the guide is not binding, the information requested
will be required in order to avoid delays in the examination of
the application.

Practice has shown that applications have been processed more
rapidly if they were presented in the form of a technical file
containing all of the information required to assess the above
requirements.

Consequently,
this working paper is not hard-and-fast but
could be amended to bring it into line with the experience
gained within the Working Party and with advances in scien-
tific and technical knowledge about fertilizers.

Addresses of the services in the Member States to which appli-
cations should be sent are also included.

2. CONTENTS OF THE TECHNICAL FILE

The Member State will subsequently transmit the application to
the appropriate Commission working party for examination.

The file must contain at least five separate chapters:

— information on effects on health, environment and safety,

This document has been prepared in cooperation with experts
representing:

— agronomic data,

(1) the authorities concerned in the Member States,

— details of the methods of analysis and the results,

— a proposal for inclusion in Annex I to Regulation (EC) No

(2) companies in the ‘European Fertilizer Manufacturers' Asso-

2003/2003,

ciation’ (EFMA),

— any other relevant information.

(3) the European Committee for Standardization (CEN) TC

260.

3. DESCRIPTION OF THE INFORMATION REQUIRED IN EACH

CHAPTER

1. OBJECTIVE

3.1. Information on health, the environment and safety

The aim of this document is to set out as closely as possible
the information needed by the Commission's Working Party on
Fertilizers to enable it to evaluate the requests for entries in
Annex I to Regulation (EC) No 2003/2003 (1) and, in the light
thereof, eventually designate them as ‘EC fertilizer’.

It is therefore a guide for any person (manufacturer or his
representative) who wishes to submit a fertilizer or type of
fertilizer for designation as ‘EC fertilizer’.

This information file is the result of the implementation of
Article 14 of the Regulation (EC) No 2003/2003 which stipu-
lates that:

3.1.1. Safety data sheet

Draw up a safety data sheet containing the headings listed in
Directive 91/155/EEC of 5 March 1991 (2) as modified by
Directive 93/112/EEC of 10 December 1993 (3) and by Direc-
tive 2001/58/EC of 27 July 2001 (4) in accordance with the
explanatory notes given in the Annex to that Directive.

Although it is not obligatory for every fertilizer under existing
Community legislation- the safety data sheet is an excellent
source of information, even if in some cases certain headings
do not apply to the fertilizer product proposed.

(a) it provides nutrients in an effective manner;

3.1.2. Additional information

(b) relevant sampling, analysis, and if required, test methods

are being provided.

(c) under normal conditions of use it does not adversely affect

human, animal, or plant health, or the environment.

(1) OJ L 304, 21.11.2003, p. 1.

In addition, state undesirable substances and chemical or biolo-
gical agents which have or may have an effect on human or
animal health or the environment, as far as is known.

(2) OJ L 76, 22. 3. 1991, p. 35.
(3) OJ L 314, 16. 12. 1993.
(4) OJ L 212, 7.8.2001, p. 24.

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3.2. Agronomic data

3.2.1. Main effect and secondary effects

Describe the main effect obtained by application of the product
under the conditions of use advocated and state the active
ingredient(s) responsible for the effect claimed. Explain how the
nutrient(s) in the product is/are made available to the crop. The
secondary
characterized and
explained as far as possible.

effects must be

identified,

Although a scientific explanation of the action of the product
is desirable, it is not necessary provided that positive and repro-
ducible results are obtained under the conditions of use advo-
cated.

3.2.2. Method of use of the product

In general, provide all the information necessary to enable
effective use of the product.

This is a matter of describing the conditions of use of the
finished product according to good agricultural practice.

It is not desirable to indicate ‘all crops’, but rather to
Crops:
select crops for which the effectiveness of the product has been
demonstrated.

Indicate the amount required to obtain the
Application rates:
main effect on the crop concerned. It must be expressed both
as a quantity of the finished product as marketed and a quan-
tity (quantities) of the corresponding nutrient(s).

The application rate must be indicated according to agricultural
practice, e.g. in kilogram of product per hectare per year. If the
product is applied several times to the same crop, indicate the
rate per application and the number of applications. In the case
of products diluted before use, indicate the volume of diluent
required.

Method of application: Specify whether the product is to be
applied directly to the soil or to the plant (leaves, fruit, xylen or
roots). Indicate the methods of application, e.g. broadcast or
injection, sprinkling, trick-
localized application, by spraying,
ling, dusting, flowing solution. etc. Specify the calendar periods
for application or the plant development stages (phenological
stages) for which application is effective.

Special conditions of use: This involves supplementing the infor-
mation on the use of the product, e.g. types of soils and their
nutrient status, climatic and growing conditions. Describe the
situations in which the use of the product is prohibited or not
recommended, possible mixes, prohibited mixes, etc.

3.2.3. Efficacy

Give clear (comprehensible) information demonstrating the effi-
cacy of the product when used under the conditions described.

If necessary, supply an experimental schedule to show the main
effect, together with detailed results of trials on yield and/or
crop quality. Include any relevant analyses of the soil and flora
to show the nutrient levels in the crop, the type of soil and the
basic agronomic data.

If the test results have been published, provide a photocopy of
the publication in a Community language, if appropriate.

3.3. Details of the methods of analysis and results

Indicate the methods used to analyze the product: EC, ISO,
CEN, AOAC methods, national methods, etc. EC methods have
to be used except if not appropriate.

A report of the results of the various analyses carried out on
the product by a laboratory approved for fertilizer analysis
should also be added as supplementary Information. If non-
standard ‘in-house’ methods are used for some of the analyses,
provide an annex giving full details, including a description of
the method used to prepare the samples. The use of these not
standardized methods has to be justified

3.4. Proposal for inclusion in Annex I to Regulation (EC)

No 2003/2003

Draw up a proposed entry based on the presentation adopted
in Annex I to Regulation (EC) No 2003/2003 and the subse-
quent amendments thereto indicate their type designation and
provide information in the appropriate columns.

3.5. Other information

Add any other information considered to be relevant and not
covered in the previous chapters. As full a bibliography as
possible will complete this chapter.

4. PROCEDURE FOR LODGING OF THE FILE

Any person (manufacturer or his representative) wishing to
have a fertilizer designated as an ‘EC fertilizer’ must submit the
above technical file to the Member State authorities.

The Member State concerned will then act as rapporteur for
the file to the Working Party on Fertilizers of the Commission
of the European Communities.

In the light of the conclusions of the Working Party on Fertili-
zers, the Commission will draft a proposal to adapt Annex I to
Regulation (EC) No 2003/2003 which will be submitted to the
Committee referred to in Article 32 of the above Regulation
for an opinion, in accordance with the procedure laid down in
Article 5 and 7 of Decision 1999/468/EC.

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AUTHORITIES IN THE MEMBER STATES CONCERNED WITH THE REGISTRATION OF NEW NATIONAL
FERTILIZERS

Austria

Belgium

Cyprus

Czech Republic

Österreichische Agentur für
Gesundheit und Ernährungssicher-
heit GmbH
Landwirtschaftliche Untersuchungen
und Forschung Wien

FPS ‘Public Health, Food Chain
Safety and Environment’
General Directorate ‘Animals,
Plants and Food’
Service Pesticides and Fertilisers

Ministry of Agriculture, Natural
Resources and Environment
Department of Agriculture
Land and Water use Section

CY-1411 Nicosia

Central Institute for Supervising
and Testing in Agriculture

ÚKZÚZ
Hroznová 2
CZ-656 06 Brno

Spargeldstrasse 191
Postfach 400
AT-1226 Wien

Tel. (43-1) 732 16 31 59
Fax (43-1) 732 16 31 07

e-mail:
michael.dachler@lwvie.ages.at
adelheid.spiegel@lwvie.ages.at

Eurostation
Bloc II
Place Victor Horta 40/10
BE-1060 Brussels

Tel. (32-2) 524 72 65
Fax (32-2) 524 72 99

e-mail:
aft.plant@health.fgov.be
nele.vanhauwe@health.fgov.be

Web:
http://www.health.fgov.be

Tel. (357) 22 305476
Fax (357) 22 305494

Tel. (420) 569 430 438
Fax (420) 569 430 412

e-mail:
doagrg@cytanet.com. cy
doagr.wateruse@cytanet.com.cy

e-mail:
pavel.cermak@ukzuz.cz

Web:
http://www.ukzuz.cz

Ministry of Agriculture of the
Czech Republic
Plant production department

Těšnov 17
CZ-117 05 Praha 1

Tel. (420) 221 812 071
Fax (420) 221 812 705

e-mail:
budnakova@mze.cz

Web:
http://www.mze.cz

Denmark

Estonia

Finland

France

Ministry of Food, Agriculture and
Fisheries
Plantedirektoratet

Skovbrynet 20
DK-2800 Lyngby

Tel. (45) 45 26 36 00
Fax (45) 45 26 36 10

e-mail:
sfg@pdir.dk

Web:
http://www.pdir.dk

Plant Production Inspectorate

Ministry of Agriculture and
Forestry

Teaduse 2
EE-75501 Saku

Tel. (372) 6712 651
Fax (372) 6712 604

e-mail:
katrin.laud@plant.agri.ee

Web:
http://www.plant.agri.ee/

P.O. Box 30
FI-00023 Government Helsinki

Tel. (358-9) 160 88 073
Fax (358-9) 160 24 43

e-mail:
pirjo.salminen@mmm.fi

Ministère de l'Agriculture et de la
Pêche
Direction Générale de l'Alimenta-
tion
Sous-Direction de la Qualité et de
la Protection des Végétaux
Bureau des Produits Antiparasi-
taires et des Matières Fertilisantes

251 rue du Vaugirard
FR-75732 Paris Cedex 15

Tel. (33-1) 49 55 81 41
Fax (33-1) 49 55 59 49

e-mail:
mfsc.sdqpv.dgal@agriculture.-
gouv.fr

Web:
http://www.service-public.fr

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Denmark

Estonia

Finland

France

Ministry of Agriculture of Estonia

39/41 Lai St Tallinn
EE-15056

Tel. (372) 62 565 07
Fax (372) 62 562 00

e-mail:
renata.tsaturjan@agri.ee

Web:
http://www.agri.ee/

Direction générale de la concur-
rence, de la consommation et de la
répression des fraudes

Boulevard Vincent Auriol, 59
FR-75703 Paris Cedex 13

Tel. (33-1) 44 97 31 54
Fax (33-1) 44 97 05 27

e-mail:
roselyne.roy@dgccrf.finances.-
gouv.fr

Web:
http://www.finances.gouv.fr/
index.html

Germany

Greece

Hungary

Ireland

Bundesministerium für Verbrau-
cherschutz, Ernährung und Land-
wirtschaft

Ministry of Agriculture
Directorate plant for inputs of
plant products
Section D

Ministry of Agriculture and Rural
Development
Department for Plant Protection
and Soil Conservation

Referat 516A
Postfach 14 02 70
DE-53107 Bonn

2, Archarnon Street
EL-101 76 Athens

Kossuth tér 11
HU-1055 Budapest

Department of Agriculture and
Food

Block B, 1st Floor
Maynooth Business Campus
Maynooth
IE-Co. Kildare

Tel. (49) 22 81 529 38 84
Fax (49) 22 81 529 55 38 89

Tel. (30) 210 21 24 102
Fax (30) 210 21 24 137

Tel. (36-1) 301 40 15
Fax (36-1) 301 46 44

Tel. (353-1) 505 33 49
Fax (353-1) 505 35 63

e-mail:
516A@bmvel.bund.de

e-mail:
ax2u056@minagric.gr

e-mail:
ekei@posta.fvm.hu

e-mail:
info@agriculture.gov.ie

Web:
http://www.agriculture.gov.ie

National Organization For Medi-
cines
(Ethnikos Organismos Farmakon
— EOF)
Division of Inspection and Distri-
bution Control

284, Messoghion Ave.
EL-155 62 Holargos

Tel. (30) 210 65 07 204
Fax (30) 210 65 49 591

e-mail:
reg@eof.gr

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Italy

Latvia

Lituania

Luxembourg

State Plant Protection Service

Republikas laukums 2,
LV-1981 Riga

Tel. (371) 702 73 09
Fax (371) 702 73 02

e-mail:
Skaidrite.rulle@vaad.gov.lv

Ministry of Economy,
Industry and Business Department,
Product Technical Regulation Divi-
sion

Ministère de l'agriculture
ASTA
Laboratoire de contrôle et d'essais

Gedimino ave. 38/2
LT-01104 Vilnius

Tel. (370 5) 262 68 10
Fax (370 5) 262 39 74

BP 75
LU-9001 Ettelbruck

Tel. (352) 81 00 81 212
Fax (352) 81 00 81 333

e-mail:
rene.meyers@asta.etat.lu

Ministero delle politiche agricole e
forestali
Dipartimento della qualità dei
prodotti agroalimentari e dei servizi
Direzione Generale per la Qualità
dei prodotti agroalimentari e la
tutela del consumatore

Via XX Settembre, 20
IT-00187 Roma

Tel. (39-06) 466 55 020
Fax (39-06) 481 97 14

e-mail:
qualprod-tutconsum@
politicheagricole.it

Ministero delle politiche agricole e
forestali
Ispettorato centrale repressione
frodi

Via XX Settembre, 20
I-00187 Roma

Tel. (39-06) 474 38 82
Fax (39-06) 488 10 41

Web:
http://www.politicheagricole.it/

Malta

Poland

Portugal

Slovakia

Foodstuffs, Chemicals & Cosmetics
Directorate,
Malta Standards Authority

Ministerstwo Gospodarki
Pracy i Polityki Spolecznej
Departament Polityki Przemy-
słowej

2nd Floor, Evans Buildings,
Merchants Street,
MT-Valletta VLT 03

Pl. Trzech Krzyży 3/5
PL-00-507 Warszawa

Tel. (356) 21255546
Fax (356) 21242420

Tel. (48-22) 693 56 35
Fax: (48-22) 693 40 32

e-mail:
martin.seychell@msa.org.mt

e-mail:
krysen@mg.gov.pl
renzna@mg.gov.pl

Web:
http://www.mgpips.gov.pl

Ministério da Economia
Direçcão-Geral da Empresa

Avenida Visconde Valmor 72
PT-1069-041 Lisboa

Tel. (351) 21 791 91 00
Fax (351) 21 796 51 58

Ústredný kontrolný a skúšobný
ústav poľnohospodársky
Oddelenie registrácie hnojív

Matuškova 21
SK-833 16 Bratislava

Tel. (421) 2 547 758 22 ext. 202
Fax (421) 2 546 512 03

e-mail:
dgempresa@dgempresa.min-econo-
mia.pt

e-mail:
z.brana@uksup.sk

Web:
http://www.min-economia.pt

Web:
http://www.uksup.sk

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Malta

Poland

Portugal

Slovakia

Ministério da Economia
Direcção Geral da Indústria

Avenida Conselheiro Fernando de
Sousa, 11
PT-1092 Lisboa Codex

Tel. (351) 21 389 01 85
Fax (351) 21 389 01 14

Web:
http://www.min-economia.pt/

Ministerstwo Rolnictwa i Rozwoju
Wsi
Departament Hodowli i Ochrony
Roślin

ul. Wspólna 30
PL-00-930 Warszawa

Tel. (48-22) 623 21 04
Fax (48-22) 628 87 84

e-mail:
kinga.roslan@minrol.gov.pl
tj@iung.pulawy.pl

Web:
http://www.minrol.gov.pl/

Slovenia

Spain

Sweden

The Netherlands

United Kingdom

Ministry of Agriculture,
Forestry and Food
Phytosanitary Administra-
tion of RS

Einspielerjeva 6,
SI-1000 Ljubljana

Tel. (386-1) 3094 432
Fax (386-1) 3094 335

e-mail:
furs.mkgp@gov.si; darja.kro-
pivsek@gov.si

Registro de productos ferti-
lizantes
Dirección General de Agri-
cultura
Ministerio de Agricultura,
Pesca y Alimentación

C/Alfonso XII, 62
ES-28014 Madrid

Tel. (34) 91 3474086
Fax (34) 91 3474087

e-mail:
jortizde@mapya.es

Web:
http://www.mapya.es

Ministerio de Industria,
Turismo y Commercio
Dirección General de
Desarrollo Industrial

Paseo de la Castellana, 160
ES-28071 Madrid

Tel. (34) 91 349 42 22
Fax (34) 91 457 80 66

e-mail:
paloma.perez2@min.es

Web:
http://www.min.es

The Swedish Board of
Agriculture

Rikilt
Bureau meststoffen

SE-55182 Jönköping

Tel. (46) 36 15 50 00
Fax (46) 36 19 05 46

e-mail:
magnus.franzen@sjv.se

Postbus 230
NL-6700 AE Wageningen

Tel. (31-317) 47 55 74
Fax (31-317) 41 77 17

e-mail:
jaap.driessen@wur.nl

Web:
http://www.rikilt.nl

Department for Environ-
ment, Food & Rural Affairs
(DEFRA)

Area 4D
Ergon House
17 Smith Square
UK-London SW1P 3JR

Tel. (44-20) 7238 5810
Fax (44-20) 7238 6069

e-mail:
gary.beckwith@defra.gsi.-
gov.uk

Ministerie van Landbouw,
Natuur en Voedselkwaliteit
Directie Landbouw
Afdeling Mineralen en
Ammoniak

Ministry of Agriculture,
Fisheries and Food
Rural and Marine Environ-
ment Division

Postbus 20401
NL-2500 EK Den Haag

Ergon House
17, Smith Square
UK-London SW1 P3JR

Tel. (31-70) 378 42 50
Fax (31-70) 378 61 61

Tel. (44-20) 72 38 67 70
Fax (44-20) 72 38 67 00

e-mail:
h.bos@minlnv.nl

Web:
http://www.maff.gov.uk/

Web:
http://www.minlnv.nl

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AUTHORITIES IN EFTA MEMBER STATES CONCERNED WITH THE REGISTRATION OF NEW NATIONAL
FERTILIZERS

Iceland

Liechtenstein

Norway

Switzerland

Adfangaeftirlit
Feed, Seed and Fertilizer Inspecto-
rate

Office for Environmental Protec-
tion

RALA-building, Keldnaholt
IS-112 Reykjavik

Tel. (354) 591 1590
Fax (354) 591 1591

e-mail:
oli@adfangaeftirlit.is

Postfach 684
LI-FL 9490 Vaduz

Tel. (423) 236 61 94
Fax (423) 236 61 99

e-mail:
manfred.frick@aus.llv.li

Norwegian Food Safety Authority
Head Office
Section for Water, Feedingstuffs
and Animal By-Products

P.O. Box 383
NO-2381 Brumunddal

Tel. (47) 23 21 68 00
Fax (47) 23 21 70 01

e-mail:
postmottak@mattilsysnet.no
line.diana.blytt@mattilsynet.no

Web:
http://www.mattilsynet.no

Office Fédéral de l'Agriculture
Division Moyens de Production

Mattenhofstrasse 5
CH-3003 Bern

Tel. (41) 32 323 83 85
Fax (41) 31 322 26 34

e-mail:
duenger@blw.admin.ch

Web:
http://www.blw.admin.ch