Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (Text with EEA relevance)
CHAPTER 1 — GENERAL PROVISIONS AND DEFINITIONS
Scope
1. This Regulation lays down detailed rules for the initial implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC concerning the placing of plant protection products on the market, hereinafter referred to as the "Directive".
2. The initial implementation of this fourth stage concerns the notification of the active substances referred to in Annexes I and II to this Regulation with a view to their possible inclusion in a subsequent priority list of active substances with a view to their possible inclusion in Annex I to the Directive. Article 6(2), Article 6(3) and the second subparagraph of Article 6(4) of the Directive shall not apply to a substance listed or referred to in Annexes I and II as long as the procedures provided in this Regulation with regard to these substances have not been finalised.
3. This Regulation shall apply without prejudice to:
(a) reviews by Member States in particular pursuant to renewals of authorisations in accordance with Article 4(4) of the Directive;
(b) reviews by the Commission pursuant to Article 5(5) of the Directive;
(c) assessments carried out under Directive 79/117/EEC.
Definitions
The following definitions shall apply for the purposes of this Regulation:
(a) "Producer" means:
- for active substances produced within the Community, the manufacturer or a person established within the Community designated by the manufacturer as his/her sole representative for the purpose of compliance with this Regulation,
- for active substances produced outside the Community, the person established within the Community and designated by the manufacturer as his/her sole representative within the Community for the purpose of compliance with this Regulation,
- for active substances for which a joint notification or joint dossier is submitted, the association of producers established within the Community and designated by the producers referred to in the first or second indent for the purpose of compliance with this Regulation.
(b) "Manufacturer" means the person who manufactures the active substance on his/her own or who contracts out to another party the manufacturing of the active substance on its behalf.
(c) "Committee" means the Standing Committee on the Food Chain and Animal Health, established by Article 19 of the Directive.
Member State authority
1. Member States shall allocate responsibility for the implementation of their obligations under the programme of work referred to in Article 8(2) of the Directive to an authority or authorities.
2. In each Member State one national authority, referred to in Annex VI, shall coordinate and ensure all necessary contacts with producers, other Member States and the Commission pursuant to this Regulation. Each Member State shall inform the Commission and the designated coordinating national authority of each other Member State of any modifications to the communicated details concerning the designated coordinating national authority.
CHAPTER 2
FOURTH STAGE OF THE PROGRAMME OF WORK
CHAPTER 2 — FOURTH STAGE OF THE PROGRAMME OF WORK
Basic notification
1. Any producer wishing to secure the inclusion of an active substance referred to in Annex I to this Regulation, in Annex I to the Directive shall so notify to the body referred to in Annex V. The Commission will regularly follow up the tasks mentioned in Annex V entrusted to the body designated in that Annex. In accordance with the procedure laid down in Article 19 of the Directive it may be decided to designate another body where it would appear that the tasks are not adequately performed.
2. Notification must be submitted for each active substance separately within three months of the date of entry into force of this Regulation in accordance with the model notification as shown in part 1 of Annex III hereto including a written commitment to present a dossier.
3. Any producer who has not notified any given active substance referred to in paragraph 1 within the deadline referred to in paragraph 2 or whose notification was rejected in accordance with the provisions of Article 6 will be permitted to participate in the review programme only collectively with one or more notifiers of the active substance (including a Member State which has notified in accordance with Article 6(2)), whose notification was accepted in accordance with Article 6, in submitting a joint dossier.
Full notification
1. Any producer wishing to secure the inclusion of an active substance referred to in Annex II to this Regulation, in Annex I to the Directive shall so notify to the body designated in Annex V.
2. Notification must be submitted for each active substance separately, as follows:
(a) within three months of the date of entry into force of this Regulation, a first notification, in accordance with the model notification as shown in Annex III, part 1 hereto, and
(b) within six months of the date of entry into force of this Regulation, a second notification, in accordance with the model notification as shown in Annex III, part 2 hereto, including a written commitment to present a complete dossier.
3. Any producer who has not notified any given active substance referred to in paragraph 1 within the deadline referred to in paragraph 2 or whose notification was rejected in accordance with the provisions of Article 6 will be permitted to participate in the review programme only collectively with one or more notifiers of the active substance, including a Member State which has notified in accordance with Article 6(2), whose notification was accepted in accordance with Article 6, in submitting a joint dossier.
Examination of basic notifications and full notifications
1. The Commission shall, within two months after the deadline referred to in Article 4(2) and Article 5(2)(a), inform the Committee on the notifications submitted before the deadline.
2. For any active substance for which no producer has submitted a notification, a Member State may declare its interest in securing the inclusion of that active substance in Annex I to the Directive by notifying the body designated in Annex V in accordance with Article 4 or 5. Such notifications must be submitted as soon as possible, and no later than three months after the Commission has informed the Member States that no notification was submitted for that substance. A Member State submitting a notification shall thereafter be treated as the producer for the purposes of the evaluation of the active substance concerned.
3. The Commission shall, at the latest six months after the deadlines referred to in Article 4(2) and Article 5(2), inform the Committee on the admissibility of the notifications received taking into account the criteria referred to in Annex IV, parts 1 and 2.
4. Detailed provisions concerning the submission of dossiers, the deadline(s) for their submission and the fee regime for the active substances for which an admissible notification was received shall be established by the Commission in a Regulation to be adopted in accordance with the second subparagraph of Article 8(2) of the Directive.
5. The Commission shall decide, as provided for in the fourth subparagraph of Article 8(2) of the Directive, not to include in Annex I to the Directive active substances referred to in Annex I or II to this Regulation for which no admissible notification has been submitted within the established time limit. The decision shall state the reasons for the non-inclusion. Member States shall withdraw authorisations of plant protection products containing these active substances within the period prescribed in the Decision.
CHAPTER 3
FEES
Fees for the notification for the fourth stage of the work programme
1. Any producer submitting a notification in accordance with the provisions of Article 4 shall at the time of the submission of its notification pay a fee of EUR 750 for each active substance to the body designated in Annex V. The fee shall be used to finance exclusively the costs actually incurred for the tasks referred to in Annex V.
2. Any producer submitting a notification in accordance with the provisions of Article 5(2)(a) shall at the time of the submission of its notification pay a fee of EUR 5000 for each active substance to the body designated in Annex V. The fee shall be used to finance exclusively the costs actually incurred for the tasks referred to in Annex V.
CHAPTER 4
FINAL PROVISION
CHAPTER 4 — FINAL PROVISION
Temporary measures
In a decision to phase out an active substance for which no admissible notification has been submitted, pursuant to fourth subparagraph of Article 8(2) of Directive 91/414/EC the Commission may, where additional technical evidence has been provided by a Member State demonstrating an essential need for further use of that substance and the absence of any effective alternative, prescribe a phasing out period which is sufficiently long to enable suitable alternatives to be developed.
Entry into force
This Regulation shall enter into force on 1 August 2002.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 June 2002.
For the Commission
David Byrne
Member of the Commission
(1) OJ L 230, 9.8.1991, p. 1.
(2) OJ L 148, 6.6.2002, p. 19.
(3) OJ L 366, 15.12.1992, p. 10.
(4) OJ L 259, 13.10.2000, p. 27.
(5) OJ L 55, 29.2.2000, p. 25.
(6) OJ L 33, 8.2.1979, p. 36.
(7) OJ L 92, 13.4.1991, p. 42.
Supplementary provisions
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
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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
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