EN Official Journal of the European Union C 250/2

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 fertilizers.

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

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

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

This document has been prepared in cooperation with experts representing:

(1) the authorities concerned in the Member States,

(2) companies in the ‘European Fertilizer Manufacturers' Association’ (EFMA),

(3) the European Committee for Standardization (CEN) TC 260.

1. OBJECTIVE

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 stipulates that:

(a) it provides nutrients in an effective manner;

(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.

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 scientific and technical knowledge about fertilizers.

2. CONTENTS OF THE TECHNICAL FILE

The file must contain at least five separate chapters:

— information on effects on health, environment and safety,

— agronomic data,

— details of the methods of analysis and the results,

— a proposal for inclusion in Annex I to Regulation (EC) No 2003/2003,

— any other relevant information.

3. DESCRIPTION OF THE INFORMATION REQUIRED IN EACH CHAPTER

3.1. Information on health, the environment and safety

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 Directive 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.

3.1.2. Additional information

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

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 effects must be identified, characterized and explained as far as possible.

Although a scientific explanation of the action of the product is desirable, it is not necessary provided that positive and reproducible results are obtained under the conditions of use advocated.

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.

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

Application rates: Indicate the amount required to obtain the main effect on the crop concerned. It must be expressed both as a quantity of the finished product as marketed and a quantity (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 localized application, by spraying, injection, sprinkling, trickling, 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 information 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 efficacy 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 subsequent 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 Fertilizers, 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.

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

Austria Belgium Cyprus Czech Republic Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Landwirtschaftliche Untersuchungen und Forschung Wien 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 FPS ‘Public Health, Food Chain Safety and Environment’ General Directorate ‘Animals, Plants and Food’ Service Pesticides and Fertilisers 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 Ministry of Agriculture, Natural Resources and Environment Department of Agriculture Land and Water use Section CY-1411 Nicosia Tel. (357) 22 305476 Fax (357) 22 305494 e-mail: doagrg@cytanet.com. cy doagr.wateruse@cytanet.com.cy Central Institute for Supervising and Testing in Agriculture ÚKZÚZ Hroznová 2 CZ-656 06 Brno Tel. (420) 569 430 438 Fax (420) 569 430 412 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 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/ Ministry of Agriculture and Forestry 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'Alimentation Sous-Direction de la Qualité et de la Protection des Végétaux Bureau des Produits Antiparasitaires 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 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 concurrence, 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 Verbraucherschutz, Ernährung und Landwirtschaft Referat 516A Postfach 14 02 70 DE-53107 Bonn Tel. (49) 22 81 529 38 84 Fax (49) 22 81 529 55 38 89 e-mail: 516A@bmvel .bund.de Ministry of Agriculture Directorate plant for inputs of plant products Section D 2, Archarnon Street EL-101 76 Athens Tel. (30) 210 21 24 102 Fax (30) 210 21 24 137 e-mail: ax2u056@minagric.gr Ministry of Agriculture and Rural Development Department for Plant Protection and Soil Conservation Kossuth tér 11 HU-1055 Budapest Tel. (36-1) 301 40 15 Fax (36-1) 301 46 44 e-mail: ekei@posta .fvm.hu Department of Agriculture and Food Block B, 1st Floor Maynooth Business Campus Maynooth IE-Co. Kildare Tel. (353-1) 505 33 49 Fax (353-1) 505 35 63 e-mail: info@agriculture .gov.ie Web: http://www .agriculture.gov.ie National Organization For Medicines (Ethnikos Organismos Farmakon — EOF) Division of Inspection and Distribution 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





Italy Latvia Lituania Luxembourg 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 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 Division Gedimino ave. 38/2 LT-01104 Vilnius Tel. (370 5) 262 68 10 Fax (370 5) 262 39 74 Ministère de l'agriculture ASTA Laboratoire de contrôle et d'essais 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 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 2nd Floor, Evans Buildings, Merchants Street, MT-Valletta VLT 03 Tel. (356) 21255546 Fax (356) 21242420 e-mail: martin.seychell@msa.org.mt Ministerstwo Gospodarki Pracy i Polityki Spolecznej Departament Polityki Przemysłowej Pl. Trzech Krzyży 3/5 PL-00-507 Warszawa Tel. (48-22) 693 56 35 Fax: (48-22) 693 40 32 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 e-mail: dgempresa@dgempresa.min-economia.pt Web: http://www.min-economia.pt 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: z.brana@uksup.sk Web: http://www.uksup.sk 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/ 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/





Slovenia Spain Sweden The Netherlands United Kingdom Ministry of Agriculture, Forestry and Food Phytosanitary Administration of RS Einspielerjeva 6, SI-1000 Ljubljana Tel. (386-1) 3094 432 Fax (386-1) 3094 335 e-mail: furs.mkgp@gov.si; darja.kropivsek@gov.si Registro de productos fertilizantes Dirección General de Agricultura 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 The Swedish Board of Agriculture SE-55182 Jönköping Tel. (46) 36 15 50 00 Fax (46) 36 19 05 46 e-mail: magnus.franzen@sjv.se Rikilt Bureau meststoffen 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 Environment, 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 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 Ministerie van Landbouw, Natuur en Voedselkwaliteit Directie Landbouw Afdeling Mineralen en Ammoniak Postbus 20401 NL-2500 EK Den Haag Tel. (31-70) 378 42 50 Fax (31-70) 378 61 61 e-mail: h.bos@minlnv.nl Web: http://www.minlnv.nl Ministry of Agriculture, Fisheries and Food Rural and Marine Environment Division Ergon House 17, Smith Square UK-London SW1 P3JR Tel. (44-20) 72 38 67 70 Fax (44-20) 72 38 67 00 Web: http://www.maff.gov.uk/

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

Iceland Liechtenstein Norway Switzerland Adfangaeftirlit Feed, Seed and Fertilizer Inspectorate RALA-building, Keldnaholt IS-112 Reykjavik Tel. (354) 591 1590 Fax (354) 591 1591 e-mail: oli@adfangaeftirlit.is Office for Environmental Protection 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

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

(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.