ANNEX ISupplementary provisions
Active substances covered by the basic notification for the fourth stage of the work programme provided for in Article 8(2) of the Directive All active substances (including any variants thereof such as salts, esters or amines) that were on the market before 25 July 1993 except those which are covered by: - Regulation (EEC) No 3600/92, - Regulation (EC) No 451/2000, - Annex II to this Regulation, Notwithstanding the above exceptions, substances which were previously considered to be covered by Directive 98/8/EC of the European Parliament and of the Council(1) but which, following clarification of the scope of the Directive, are now considered to fall within the scope of Directive 91/414/EEC and were included in Regulation (EC) No 451/2000, may be notified under Article 4. This applies in particular to substances authorised as disinfectants i.e. products applied indirectly (for example for the disinfection or the disinfestation of empty store rooms or other structures and articles like greenhouses, growing houses, containers, boxes, sacks, barrels etc.) where the purpose of the use is to destroy organisms exclusively and specifically harmful to plants or plant products and after the treatment only plants or plants products will be grown or stored in the treated structures. All substances belonging to the following categories have to be notified even if they are not mentioned in the table further below: - active substances of which the use is authorised in human foodstuffs or animal feeding stuffs in accordance with EU-legislation, - active substances which are plant extracts, - active substances which are animal products or derived thereof by simple processing, - active substances, which are or will be exclusively used as attractants or repellants (including pheromones). Active substances, which are or will be exclusively used in traps and/or dispensers, in conformity with Council Regulation (EEC) No 2092/91(2) concerning organic farming. In particular all substances listed in, or falling within a category listed in the following table, should be notified in accordance with Article 5: (4E-7Z)-4,7-Tridecadien-1-yl-acetate (4Z-9Z)-7,9-Dodecadien-1-ol (7Z-11Z)-7,11-Hexadien-1-yl- acetate (E)-10-Dodecenyl acetate (E)-11-Tetradecenyl acetate (E)7-(Z)9-Dodecadienyl acetate (E,E)-8,10-Dodecadien-1-ol (E/Z)-8-Dodecenyl acetate (Z)-11-Hexadecanole (Z)-11-Tetradecen-1-yl-acetate (Z)-13-Octadecanole (Z)-3-Methyl-6-isopropenyl-3,4- decadien-1yl (Z)-3-Methyl-6-isopropenyl--9-decen-1-yl acetate (Z)-5-Dodecen-1-yl acetate (Z)-7-Tetradecanole (Z)-7-Tetradecenal (Z)-8-Dodecenol (Z)-8-Dodecenyl acetate (Z)-9-Dodecenyl acetate (Z)-9-Hexadecenal (Z)-9-Tetradecenyl acetate (Z)-9-Tricosene (Z,E)-11-Tetradecadien-1-yl acetate (Z,Z) Octadienyl acetate 1,7-Dioxaspiro-5,5-undecan 1-Decanol 2-Phenylphenol (incl. Sodium salt) 2-Propanol 3,7-Dimethyl-2,6-octadien-1-ol 3,7-Dimethyl-2,6-octadienal 4-chloro-3-methylphenol 5-Decen-1-ol 5-Decen-1-yl acetate 6-Benzyladenine 7,8-Epoxi-2-methyl-octadecane 7-Methyl-3-methylene-7-octene-1-yl-propionate Acetic acid Acridinic bases Alkyldimethybenzyl ammonium chloride Alkyldimethylethylbenzyl ammonium chloride Aluminium ammonium sulfate Aluminium sulphate Amino acids Ammonium carbonate Ammonium hydroxide Ammonium sulphate Anthraquinone Azadirachtin Barium nitrate Biphenyl Bone oil Boric acid Calcium carbide Calcium carbonate Calcium chloride Calcium hydroxide Calcium oxide Carbon dioxide Chlorhydrate of poly(imino imido biguanidine) Chlorophylline Choline chloride cis-7,trans-11-hexadecadienyl acetate cis-Zeatin Citronellol Cystein Denathonium benzoate Didecyl-dimethylammonium chloride Dioctyldimethyl ammonium chloride Dodecyl alcohol EDTA and salts thereof Ethanol Ethoxyquin Farnesol Fatty acids including esters and salts such as(3): - Decanoic acid - Ethylhexanoate - Ethyloleate - Fatty acid potassium salt - Pelargonic acid Fatty alcohols Folic acid Formaldehyde Formic acid Garlic extract Gelatine Gibberellic acid Gibberellin Glutaraldehyde Grease (bands, fruit trees) Hydrogen peroxide Hydrolysed proteins Indolylacetic acid Indolylbutyric acid Iron sulphate Kieselgur (Diatomaceous earth) Lactic acid Lauryldimethylbenzylammonium bromide Lauryldimethylbenzylammonium chloride Lecithin Lime phosphate Lime sulphur Methyl nonyl ketone Methyl-trans-6-nonenoate Naphtalene 1-Naphtylacetamide 1-Naphtylacetic acid 2-Naphtyloxyacetamide 2-Naphtyloxyacetic acid Naphtylacetic acid ethylester Nicotine Nitrogen Octyldecyldimethyl ammonium chloride Onion extract Oxyquinoline Papaine Paraffin oil p-Cresyl acetate Pepper Petroleum oils Pherodim Phosphoric acid Phoxim Plant oils such as(4): - Coconut oil - Daphne oil - Etheric oils - Eucalyptus oil - Maize oil - Olive oil - Peanut oil - Pinus oil - Rape seed oil - Soya oil - Sunflower seed oil Potassium permanganate Potassium sorbate Pronumone Propionic acid Pyrethrins Quartz sand Quassia Quaternary ammonium compounds Quinoline derivatives Repellants (by smell) of animal or plant origin Resins and polymers Rock powder Rotenone Sea-algae extract Seaweed Sebacic acid Serricornin Sillicates (sodium and potassium) Silver iodide Sodium P-toluenesulphon-chloramide Sodium carbonate Sodium chloride Sodium hydrogen carbonate Sodium hydroxide Sodium hypochlorite Sodium lauryl sulfate Sodium metabisulphite Sodium o-benzyl-p-chlorphenoxide Sodium ortho phenyl phenol Sodium propionate Sodium p-t-amylphenoxide Sodium tetraborate Soybean extract Soybeanoil, epoxylated Sulphur and Sulphur dioxide Sulphuric acid Tar oils trans-6-Nonen-1-ol trans-9-Dodecyl acetate Trimedlure Urea Waxes (1) OJ L 123, 24.4.1998, p. 1. (2) OJ L 198, 22.7.1991, p. 1. (3) Each fatty acid has to be notified separately but not their variants. (4) Each plant oil has to be notified separately. ANNEX II All active substances ( including any variants thereof such as salts, esters or amines) covered by the full notification for the fourth stage of the work programme provided for in Article 8(2) of the Directive. Active substances ( including any variants thereof) that were on the market before 25 July 1993 which: 1. are microorganisms including viruses, including the following: Aschersonia aleyrodis Agrotis segetum granulosis virus Bacillus sphaericus Bacillus thuringiensis including:(1) - subspecies aizawai - subspecies israelensis - subspecies kurstaki - subspecies tenebrionis Beauveria bassiana Beauveria brongniartii (syn. B. tenella) Cydia pomonella granulosis virus Mamestra brassica nuclear polyhedrosis virus Metarhizium anisopliae Neodiprion sertifer nuclear polyhedrosis virus Phlebiopsis gigantea Streptomyces griseoviridis Tomato mosaic virus Trichoderma harzianum Trichoderma polysporum Trichoderma viride Verticillium dahliae Kleb. Verticillium lecanii 2. are used as rodenticides (products applied in plant growing areas (agricultural field, greenhouse, forest) to protect plants or plant products temporarily stored in the plant growing areas in the open without using storage facilities), including the following: Brodifacoum Bromadiolone Bromethalin Calciferol Calcium phosphate Chloralose Chlorophacinone Cholecalciferol Coumachlor Coumafuryl Coumatetralyl Crimidine p-Dichlorobenzene Difenacoum Difethialone Diphacinone Ethanethiol Flocumafen Fluoroacetamide Isoval Papaine Phosphine and phosphine developing compounds such as: - aluminium phosphide - calcium phosphide - magnesium phosphide - zinc phosphide Pyranocumarin Scilliroside Sodium cyanide Sodium dimethylarsinate Strychnine Sulfaquinoxaline Thallium sulphate Thiourea Tricalcium phosphate 3. are used on stored plants or plant products, including the following: Cyanides such as: - calcium cyanide - hydrogen cyanide - sodium cyanide Phosphine and phosphine developing compounds such as: - aluminium phosphide - magnesium phosphide (1) Each subspecies has to be notified separately. ANNEX III >PIC FILE= "L_2002168EN.002302.TIF"> >PIC FILE= "L_2002168EN.002401.TIF"> >PIC FILE= "L_2002168EN.002501.TIF"> >PIC FILE= "L_2002168EN.002601.TIF"> >PIC FILE= "L_2002168EN.002701.TIF"> ANNEX IV PART 1 Criteria for the acceptance of notifications referred to in Article 4 A notification will only be accepted if the following is satisfied: 1. it is presented within the time limit referred to in Article 4(2). 2. it is introduced by a notifier who is a producer as defined in Article 2(a) for an active substance as defined by the Directive and which are placed on the market and used for the purpose of plant protection. 3. it is presented in the format as provided for in Annex III, part 1. 4. a fee as referred to in Article 7(1) has been paid. PART 2 Criteria for the acceptance of notifications referred to in Article 5 A notification will only be accepted if the following is satisfied: 1. it is presented within the time limit referred to in Article 5(2). 2. it is introduced by a notifier who is a producer as defined in Article 2(a) for an active substance as defined by the Directive and which are placed on the market and used for the purpose of plant protection. 3. it is presented in the format as provided for in Annex III, part 2. 4. it appears from the completeness check that the dossier currently available is sufficiently complete or a time plan to complete it is proposed. 5. the list of endpoints is sufficiently complete. 6. a fee as referred to in Article 7(2) has been paid. ANNEX V Designated body referred to in Articles 4 and 5 The following body is designated to perform on behalf of the Commission the tasks referred to in Article 6: Biologische Bundesanstalt für Land und Forstwirtschaft (RENDER 4), Messeweg 11-12 D-38104 Braunschweig (website: http://www.bba.de/english/render/htm or e-mail: render@bba.de). The fee referred to in Article 7 has to be paid to: account holder: Bundeskasse Halle account No: 8000 10 20 BLZ 800 000 00, Landeszentralbank Halle IBAN: DE 588 00 00 00 00 8000 10 20 BIC: ZBNS DE 21 800 (reference "BBA-RENDER 4" mentioning the reference number of the notification). This body will: 1. examine the notifications referred to in Articles 4 and 5; 2. prepare and make available to the notifiers the format of the notification referred to in Article 4(2) and Article 5(2); 3. examine the notifications and, if necessary, consult with experts from other Member States in the light of the acceptability criteria referred to in Annex IV; 4. report to the Commission at the latest within 3 months from the deadline referred to in Article 4(2) and Article 5(2) and on the acceptability of the notifications received; 5. make available to the Commission the notifications received; 6. make a detailed account available to the Commission; 7. if the total amount of fees paid by all notifiers exceeds the real cost of the examination and administrative treatment of all notifications, refund the balance to the notifiers in equal shares. ANNEX VI COORDINATING AUTHORITY IN THE MEMBER STATES AUSTRIA Bundesamt und Forschungszentrum für Landwirtschaft Spargelfeldstraße 191 A - 1226 Vienna BELGIUM Ministère des classes moyennes et de l'agriculture Service qualité des matières premières et analyses WTC 3, 8e étage Boulevard S. Bolivar 30 B - 1000 Brussels DENMARK Ministry of Environment Danish Environmental Protection Agency Pesticide Division Strandgade 29 DK - 1401 Copenhagen K GERMANY Biologische Bundesanstalt für Land- und Forstwirtschaft (BBA) Abteilung für Pflanzenschutzmittel und Anwendungstechnik (AP) Messeweg 11-12 D - 38104 Brunswick GREECE Hellenic Republic Ministry of Agriculture General Directorate of Plant Produce Directorate of Plant Produce Protection Department of Pesticides 3-5 Hippokratous Street GR - 10164 Athens SPAIN Ministerio de Agricultura, Pesca y Alimentación Dirección General de Agricultura Subdirección General de Medios de Producción Agrícolas C/ Ciudad de Barcelona, 118-120 E - 28007 Madrid FINLAND Plant Production Inspection Centre Pesticide Division P.O. BOX 42 FIN - 00501 Helsinki FRANCE Ministère de l'agriculture et de la pêche Direction générale de l'alimentation Sous-direction de la qualité et de la protection des végétaux 251, rue de Vaugirard F - 75732 Paris Cedex 15 IRELAND Pesticide Control Service Department of Agriculture, Food and Rural Development Abbotstown Laboratory Complex Abbotstown, Castleknock Dublin 15 Ireland ITALY Ministero della Sanità Dipartimento degli Alimenti, Nutrizione e Sanità Pubblica Veterinaria Ufficio XIV Piazza G. Marconi, 25 I - 00144 Rome LUXEMBOURG Administration des services techniques de l'agriculture Service de la protection des végétaux Boîte postale 1904 16, route d'Esch L - 1019 Luxembourg NETHERLANDS College voor de Toelating van Bestrijdingsmiddelen PO Box 217 6700 AE Wageningen The Netherlands PORTUGAL Direcção-Geral de Protecção das Culturas, Quinta do Marquês P - 2780-155 Oeiras SWEDEN National Chemicals Inspectorate P.O. Box 1384 S - 17127 Solna UNITED KINGDOM Pesticides Safety Directorate Department for Environment, Food and Rural Affairs Mallard House, Kings Pool, 3 Peasholme Green, York, YO1 7PX United Kingdom