Commission Decision

of 21 June 2007

concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances

(notified under document number C(2007) 2576)

(Text with EEA relevance)

(2007/442/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to the Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [1], and in particular the fourth subparagraph of Article 8(2) thereof,

Whereas:

(1) Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.

(2) Commission Regulations (EC) No 1112/2002 [2] and (EC) No 2229/2004 [3] lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC.

(3) Regulation (EC) No 2229/2004 provides producers in the Czech Republic, in Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, with the opportunity to participate in the fourth stage of the programme of work and organises the review of substances which were on the market in those Member States on 30 April 2004 and had not been included in the work programme.

(4) With respect to certain active substances no producer submitted a notification pursuant to Article 4(1) of Regulation (EC) No 2229/2004. When the Commission informed the Member States of this fact on 18 November 2005, no new Member State notified a declaration of interest within the deadline.

(5) With respect to certain other active substances all notifiers withdrew their participation in the programme of work. The Commission provided the Member States with this information on 4 April 2006. Only in three cases Member States have chosen to act as notifiers for the purposes of further participation in the programme of work, pursuant to Article 14(3) of Regulation (EC) No 2229/2004.

(6) For certain active substances no complete dossier has been submitted and no Member State has expressed the will to act as notifier.

(7) Consequently, the active substances referred to in recitals 4, 5 and 6, should not be included in Annex I to Directive 91/414/EEC and Member States should withdraw all authorisations for plant protection products containing those active substances.

(8) For some of those active substances information has been presented and evaluated by the Commission together with Member States‘�experts which has shown a need for further use of the substances concerned. It is therefore justified in the present circumstances to extend for certain essential uses for which there are no efficient alternatives the period for the withdrawal of authorisations while providing for strict conditions aimed at minimising any possible risk.

(9) For the active substances for which there is only a short period of advance notice for the withdrawal of plant protection products containing such substances, it is reasonable to provide for a period of grace for disposal, storage, placing on the market and use of existing stocks no longer than twelve months to allow existing stocks to be used in no more than one further growing. In cases where a longer advance notice period is provided, such period can be shortened to expire at the end of the growing season.

(10) This decision does not prejudice the submission of an application for these active substances according to the provisions of Article 6(2) of Directive 91/414/EEC in view of a possible inclusion in its Annex I.

(11) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Article 1

The active substances listed in Annex I to this Decision shall not be included as active substances in Annex I to Directive 91/414/EEC.

Article 2

Member States shall ensure that:

(a) authorisations for plant protection products containing the active substances listed in Annex I are withdrawn by 22 December 2007;

(b) no authorisations for plant protection products containing these active substances are granted or renewed from the date of publication of this Decision.

Article 3

1. By way of derogation from Article 2, a Member State listed in column B of Annex II may maintain authorisations for plant protection products containing substances listed in column A of that Annex for the uses listed in column C of that Annex until 30 June 2010, provided that it complies with the following conditions:

(a) it ensures that no harmful effects to human or animal health and no unacceptable influence to the environment are caused;

(b) it ensures that such plant protection products remaining on the market are relabelled in order to match the restricted use conditions;

(c) it imposes all appropriate risk mitigation measures to reduce any possible risks;

(d) it ensures that alternatives for those uses are seriously sought.

2. Member States making use of the derogation provided for in paragraph 1, shall inform the Commission about the measures taken under paragraph 1, and, in particular, under points (a) to (d), by 31 December of each year.

Article 4

Any period of grace granted by Member States in accordance with Article 4(6) of Directive 91/414/EEC shall be as short as possible.

For authorisations which are withdrawn in accordance with Article 2, that period shall expire on 22 December 2008 at the latest.

For authorisations which are withdrawn in accordance with Article 3, it shall expire on 31 December 2010 at the latest.

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 21 June 2007.

For the Commission

Markos Kyprianou

Member of the Commission

[1] OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/31/EC (OJ L 140, 1.6.2007, p. 44).

[2] OJ L 168, 27.6.2002, p. 14.

[3] OJ L 379, 24.12.2004, p. 13.

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ANNEX I

List of active substances which are not included as active substances in Annex I to Directive 91/414/EEC

Part A

2-hydroxyethyl butyl sulphide

2-Naphthyloxyacetamide

3-phenyl 2-propenal (Cinnamaldehyde)

Amino acids/Gamma Aminobutyric acid

Ammonium carbonate

Asphalts

Calcium chloride

Calcium hydroxide

Casein

Chitosan

Cis-Zeatin

Citronellol

Citrus extract/grapefruit extract

Citrus extract/Grapefruit seed extract

Conifer needle powder

Daphne oil

EDTA and salts thereof

Extract from Mentha piperata

Extract from plants Red oak, Pronikly pear cactus, Fragrant sumac, Red mangrove

Fatty acids/Isobutyric acid (CAS 79-31-2)

Fatty acids/Isovaleric acid (CAS 503-74-2)

Fatty acids/potassium salt ‘�caprylic acid (CAS 124-07-2)

Fatty acids/potassium salt ‘�tall oil fatty acid (CAS 61790-12-3)

Fatty Acids/Valeric acid

Folic acid

Formic acid

Garlic pulp

Gelatine

Iron pyrophosphate

Lanolin

Lecithin

Milk albumin

Mustard powder

Olein

Paraffin oil/(CAS 64741-88-4)

Paraffin oil/(CAS 64741-89-5)

Paraffin oil/(CAS 64741-97-5)

Paraffin oil/(CAS 64742-55-8)

Paraffin oil/(CAS 64742-65-0)

Paraffin oil/(CAS 8012-95-1)

Petroleum oils/(CAS 74869-22-0)

Petroleum oils/(CAS 64742-55-8/64742-57-7)

Plant oils/Olive oil

Plant oils/Etheric oil (Eugenol)

Plant oils/Gaiac wood oil

Plant oils/Garlic oil

Plant oils/Lemongrass oil

Plant oils/Orange oil

Plant oils/Pinus oil

Plant oils/Soya oil

Plant oils/Sunflower oil

Plant oils/Ylang-Ylang oil

Polymer of styrene and acrylamide

Repellent (by taste) of vegetal and animal origin/extract of food grade/phosphoric acid and fish flour

Propolis

Repellents (by smell) animal plant origin/essential oils

Repellents (by smell) of animal or plant origin/Fatty acids, fish oil

Repellents (by smell) of animal or plant origin/Tall oil crude (CAS 93571-80-3)

Sodium hydrogen carbonate

Part B

1 Methoxy-4-propenylbenzene (Anethole)

1 Methyl-4-isopropylidenecyclohex-1-ene (Terpinolene)

2-Ethyl-1, 6-dioxaspiro (4,4) nonan (chalcogran)

2 ethyl-1, 6-Dioxaspiro (4,4) nonan

2-Methoxypropan-1-ol

2-Methoxypropan-2-ol

2-Methyl-3-buten-2-ol

2-Methyl-6-methylene-2,7-octadien-4-ol (ipsdienol)

2-Methyl-6-methylene-7-octen-4-ol (Ipsenol)

2,6,6-Trimethylbicyclo[3.1.1]hept-2-ene (alpha-Pinen)

4,6,6-Trimethyl-bicyclo[3.1.1]hept-3-en-ol,((S)-cis-verbenol)

3-Methyl-3-buten-1-ol

3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (3-Carene)

(E)-2-Methyl-6-methylene-2,7-octadien-1-ol (myrcenol)

E-9-Dodecen-1-yl acetate

(8E, 10E)-8,10-Dodecadiene 1-yl acetate

(E, Z)-8,10-Tetradecadienyl

(E/Z)-9-Dodecenyl acetate; (E/Z)-9-Dodecen-1-ol; (Z)-11-Tetradecen-1-yl acetate

(IR)-1,3,3-Trimethyl-4,6-dioxatricyclo[3.3.1.0] nonane (lineatin)

Methyl p-hydroxybenzoate

p-Hydroxybenzoic acid

Part C

Agrobacterium radiobacter K 84

Bacillus sphaericus

Bacillus subtilis strain IBE 711

Baculovirus GV

Neodiprion sertifer nuclear polyhedrosis virus

Part D

Brodifacum

Chloralose

Chlorophacinone

Tricalcium phosphate

Part F

Formaldehyde

Glutaraldehyde

HBTA (High Boiling Tar Acid) Notified as Disinfectant

Hydrogen peroxide

Peracetic acid

Phoxim

Sodium p-toluenesulphon-chloramide

Part G

1,3,5 Tir-(2-hydroxyethyl)-hexa-hydro-S-triazyne

2-Mercaptobenzothiazole

2-Methoxy-5-nitrofenol sodium salt

3(3-Benzyloxycarbonyl-methyl)-2-benzothiazolinone (Benzolinone)

Biohumus

Cumylphenol

Copper complex: 8-hydroxyquinolin with salicylic acid

Ethanedial (glyoxal)

Flufenzin

Flumetsulam

Hexamethylene tetramine

Lactofen

Jasmonic acid

N-phenylphthalamic acid

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ANNEX II

List of authorisations referred to in Article 3(1)

Column A | Column B | Column C |

Active substance | Member State | Use |

Chitosan (Group A) | Poland | Vegetables and ornamentals. |

Conifer Needle powder (Group A) | Latvia | Raspberries, onions, carrots, cabbages, radishes, swedes and gladiolus. |

Calcium chloride (Group A) | The Netherlands | Chicory roots. |

Spain | Apple and pear. |

Calcium hydroxide (Group A) | The Netherlands | Orchards and nurseries of fruit trees. |

Cis-zeatin (Group A) | Portugal | Plant extract used as plant growth regulator on cereals, vegetables, orchards, vineyards, citrus fruit, ornamentals and forestry. |

Citrus extract/grapefruit extract (Group A) | Poland | Vegetables, ornamental crops and seed treatment, disinfection of indoor equipment. |

EDTA and salts thereof (Group A) | Poland | Trees in nurseries. |

Extract from mentha piperata (Group A) | Poland | Seed treatment in pre-sowing phase. |

Extract from plants Red oak, Pronikly pear cactus, Fragrant sumac, Red mangrove (Group A) | Poland | Sugar beet. |

Fatty acids/Isovaleric acid (Group A) | Poland | Potato, maize, cereals and beet. |

Fatty acids/Isobutyric acid (Group A) | Poland | Potato, maize, cereals and beet. |

Fatty acids/potassium salt ‘�caprylic acid (CAS 124-07-2) (Group A) | Poland | Control of weeds and mosses in gardens and recreational areas. |

Folic Acid (Group A) | Spain | Orchards, olives, citrus, strawberries and vegetables. |

Formic acid (Group A) | The Netherlands | Chicory. |

Garlic Pulp (Group A) | Poland | Vegetables and ornamentals crops. |

Lanolin (Group A) | Slovak Republic | Forest plantations. |

Lecithin (Group A) | Austria | Blackcurrant and fruiting vegetables. |

Germany | Ornamentals, orchards, small berries, spices, herbs and vegetables. |

Paraffin oil (CAS 64741-88-4) (Group A) | Poland | Seed potato crop. |

Paraffin oil (CAS 8012-95-1) (Group A) | Hungary | Fruit trees, grapevine, pepper, cucumber, sugar beet, ornamentals and berries. |

Spain | Cereals. |

Plants oils/Orange oil (Group A) | Poland | Lettuce. |

Repellents (by smell) of animal or plant origin/Tall oil crude (CAS 93571-80-3) (Group A) | Lithuania | Forest plantations. |

Repellents (by taste) of vegetal and animal origin/extract of food grade/phosphoric acid and fish flour (Group A) | Poland | Potato, beet, cereals, oilseed rape, leguminous crops. |

1 methoxy-4-propenylbenzene (anethole) (Group B) | Poland | Forest plantations. |

Spain | Almond, cherry, plum, apple, melon and pear. |

1 Methyl-4-isopropylidenecyclohex-1-ene (Terpinolene) (Group B) | Poland | Forest plantations. |

2,6,6,-trimethylbicyclo [3.1.1] hept 2-ene (alpha-Pinen) (Group B) | Poland | Forest plantations. |

4,6,6-trimethyl-bicyclo[3.1.1] hept-3-en-ol,((S)-cis-verbenol) (Group B) | Poland | Forest plantations. |

2-Ethyl-1, 6-dioxaspiro (4,4) nonan (chalcogran) (Group B) | Poland | Forest plantations. |

2- methyl-3 buten-2-ol (Group B) | Poland | Forest plantations. |

3,7,7-Trimethylbicyclo [4.1.0] hept-3-ene (3-Carene) (Group B) | Poland | Forest plantations. |

(E)-2-Methyl-6-methylene-2, 7-octadien-1-ol (myrcenol) (Group B) | Poland | Forest plantations. |

2-Methyl-6-methylene-2, 7-octadien-4-ol (ipsdienol) (Group B) | Poland | Forest plantations. |

Methyl p-hydroxybenzoate (Group B) | Poland | Forest plantations. |

Brodifacum (Group D) | Germany, Spain | Rodenticide: limited to pre-prepared baits if appropriately placed in specially constructed hoppers. Limited to professional users with appropriate protective equipment. |

Poland | Rodenticide and talpicide: limited to pre-prepared baits if appropriately placed in specially constructed hoppers. Limited to professional users with appropriate protective equipment. |

Chloralose (Group D) | France | Used to control populations of Corvus spp and moles. Limited to professional users with appropriate protective equipment. Restricted authorisation to applications in baits and under controlled conditions as set by a national specific Regulation. |

Chlorophacinone (Group D) | France, Germany, Spain | Rodenticide: use limited to pre-prepared baits if appropriately placed in specially constructed hoppers. Limited to professional users with appropriate protective equipment. |

Glutaraldehyde (Group F) | Belgium | Limited to professional users with appropriate protective equipment. Disinfection of agricultural tools, transportation vehicles, empty mushroom growing rooms, empty storage warehouses for plant products. |

France | Limited to professional users with appropriate protective equipment. Disinfection of empty storage warehouses for plant products and of agricultural tools. |

Poland | Limited to professional users with appropriate protective equipment. Disinfection of agricultural tools, transportation vehicles, empty storage warehouses for plant products and greenhouses. |

Hydrogen peroxide (Group F) | France | Disinfection of glasshouses, agricultural equipments and irrigation pipes. |

The Netherlands | Flowers bulbs and chicory. |

United Kingdom | Flower bulbs, potato tubers and disinfection of glasshouses, warehouses and agricultural tools and equipments. |

Peracetic acid (Group F) | France | Disinfection of glasshouses, agricultural equipments and irrigation pipes. |

Poland | Disinfection of glasshouses, warehouses and agricultural tools and equipments. |

The Netherlands | Flower bulbs. |

United Kingdom | Flower bulbs, potato tubers and disinfection of glasshouses, warehouses and agricultural tools and equipments. |

Phoxim | Slovenia | Insecticide used in soil application. |

1,3,5 Tir ‘�(2-hydroxyethyl)-hexa-hydro-S-triazyne (Group G) | Poland | Equipment, greenhouses, machines and other agricultural tools. |

Hexamethylene tetramin (Group G) | Slovak Republic | Forest plantations. |

Bio humus (Group G) | Poland | Ornamental plants and plant enhancer. |

Flufenzin (Group G) | Hungary | Fruit trees, grapevine, berries, vegetables and ornamental trees. |

Ethanedial (glyoxal) (Group G) | Poland | Limited to professional users with appropriate protective equipment. Disinfection of agricultural tools, transportation vehicles, greenhouses and empty storage warehouses for plant products. |

N- phenylphthalamic acid (Group G) | Hungary | Vegetables, sunflower, soya, alfalfa, lupine, crimson-clover, rape, rice, sour-cherry, apple and grape-vine. |

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