Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these substances (Text with EEA relevance)
Date: 2002-11-20
Institutions: European Commission
Subjects: dangerous substance, market approval, marketing, pharmaceutical product, plant health product

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COMMISSION REGULATION (EC) No 2076/2002

of 20 November 2002

extending the time period referred to in Article 8(2) of Council Directive 91/414/EEC and
concerning the non-inclusion of certain active substances in Annex I to that Directive and the
withdrawal of authorisations for plant protection products containing these substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(3)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 91/414/EEC of 15 July
1991 concerning the placing of plant protection products on
the market (1), as last amended by Commission Directive 2002/
81/EC (2), and in particular Article 8(2) thereof,

Having regard to Commission Regulation (EC) No 451/2000 of
28 February 2000 laying down the detailed rules for the imple-
mentation of
the work
programme referred to in Article 8(2) of Directive 91/414/
EEC (3), as last amended by Regulation (EC) No 1490/2002 (4),
and in particular Article 6(7) and Article 11(2) thereof,

the second and third stages of

Whereas:

(1)

(2)

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 that
are already on the market two years after the date of
notification, except where a decision has been taken not
to include a substance in Annex I.

Commission Regulation (EEC) No 3600/92 (5), as last
amended by Regulation (EC) No 2266/2000 (6), Regula-
tion (EC) No 451/2000 and Regulation (EC) No 1490/
2002 lay down the detailed rules for the implementation
of the first, second and third stages of the programme of
work referred to in Article 8(2) of Directive 91/414/EEC.
This programme is ongoing and it has not been possible
yet to complete decision making on a number of active
substances. The notification procedure for the active
substances covered by Regulation (EC) No 1112/2002 (7)
has not yet been finalised either and therefore for certain
of these active substances the time period will also need
to be extended.

(1) OJ L 230, 19.8.1991, p. 1.
(2) OJ L 276, 12.10.2002, p. 28.
(3) OJ L 55, 29.2.2000, p. 25.
(4) OJ L 224, 21.8.2002, p. 23.
(5) OJ L 366, 15.12.1992, p. 10.
(6) OJ L 259, 13.10.2000, p. 27.
(7) OJ L 168, 27.6.2002, p. 14.

The Commission presented its progress report on 26
July 2001 (8). It concluded that progress has not been as
good as was originally anticipated and therefore the
deadline should be extended for those substances still
for which industry has notified a
under
commitment to further prepare the necessary dossiers
within the time limits.

review or

(4)

(5)

(6)

For the active substances covered by the first stage the
Commission will ensure that as many decisions as
possible are taken before July 2003, acknowledging
however that for a number of active substances a deci-
sion can not be taken before 2005. Additional time is
needed to evaluate the further data required by the
Commission before it can be decided whether these
active substances satisfy the safety requirements of Direc-
tive 91/414/EEC and the Commission will ensure that
the extension of the time period will be as short as
possible.

Active substances for which a commitment to further
prepare the necessary dossier has not been notified,
should not be included in Annex I to Directive 91/414/
EEC and Member States should withdraw all authorisa-
tions for plant protection products containing such
active substances.

temporary measures

For uses for which additional technical evidence has
been provided demonstrating the essential need for
further use of the active substance and the absence of an
efficient alternative,
should be
provided to enable the development of alternatives. For
a number of uses such information has been presented
and evaluated by the Commission with Member State
experts. Derogations should be given only for cases,
which appear justified and as not giving rise to concern,
and should be restricted to the control of harmful organ-
isms, for which no efficient alternatives exist.

(7)

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

(8) COM(2001) 444 final.

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HAS ADOPTED THIS REGULATION:

Article 1

The time period of 12 years referred to in Article 8(2) of Direc-
tive 91/414/EEC is extended until 31 December 2005 for the
active substances which are assessed in the framework of Regu-
lations (EEC) No 3600/92 and the second stage under Regula-
tion (EC) No 451/2000, and until 31 December 2008 for the
active substances which are assessed in the framework of Regu-
lation (EC) No 1490/2002, unless a decision has been taken or
is taken before that date to include or not include the active
substance in Annex I to Directive 91/414/EEC. During these
periods the Member States may continue to authorise or
authorise again the placing on the market of plant protection
products containing the above mentioned active substances, in
accordance with the provisions of Article 8(2) of Directive 91/
414/EEC.

Article 2

1.
The active substances listed in Annex I to this Regulation
are not included as active substance in Annex I to Directive 91/
414/EEC.

2. Member States shall ensure that authorisations for plant
protection products containing the active substances listed in
Annex I to this Regulation are withdrawn by 25 July 2003
except as provided in paragraph 3.

In relation to a substance specified in column A of Annex
3.
II, any Member State specified in column B of that Annex in
relation to the substance may maintain in force authorisations
for plant protection products containing that substance for the
uses listed in column C until 30 June 2007 provided that it:

(b) ensures that such plant protection products remaining on
the market after 31 December 2003 are relabelled in order
to match the restricted use conditions;

(c) imposes all appropriate risk mitigation measures to reduce

any possible risks;

(d) ensures that alternatives for such uses are being seriously

sought.

The Member State concerned shall inform the Commission on
31 December 2004 at the latest on the application of this para-
graph and in particular on the actions taken pursuant to points
(a) to (d).

Article 3

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 and:

(a) for the uses for which the authorisation is to be withdrawn
by 25 July 2003, shall expire not later than 31 December
2003, except
for the limited number of essential uses
referred to in Annex II, for which the authorisation can still
be maintained in specified Member States in accordance
with the provisions of Article 2(3);

(b) for the uses for which the authorisation is to be withdrawn
by 30 June 2007, shall expire not later than 31 December
2007.

Article 4

(a) ensures that the continued use is only accepted as far it
does not have any harmful effect on human or animal
health and no unacceptable influence on the environment;

This Regulation shall enter into force on the seventh day
following its publication in the Official Journal of the European
Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 November 2002.

For the Commission

David BYRNE

Member of the Commission

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

ANNEX I

1,2-Dichloropropane

1,3-Dichloropropene (cis)

1,3-Diphenyl urea

2-(dithiocyanomethylthio)-benzothiazol

2,3,6-TBA

2,4,5-T

2-Aminobutane (aka sec-butylamine)

2-Benzyl-4-chlorophenol

4-CPA (4-chlorophenoxyaceticacid = PCPA)

4-t-Pentylphenol

Acifluorfen

Aldimorph

Alkyltrimethyl ammonium chloride

Alkyltrimethylbenzyl ammonium chloride

Allethrin

Alloxydim

Allyl alcohol

Ametryn

Ampropylofos

Ancymidol

Anilazine

Anthracene oil

Azaconazole

Azamethiphos

Aziprotryne

Barban

Barium fluosilicate

Barium polysulphide

Benazolin

Bendiocarb

Benfuresate

Benodanil

Bensulide

Bensultap

Bentaluron

Benzalkonium chloride

Benzoximate

Benzoylprop

Benzthiazuron

Bioallethrin

Bioresmethrin

Bitumen

Brandol (hydroxynonyl-2,6-dinitrobenzene)

Bromacil

Bromocyclen

Bromofenoxim

Bromophos

Bromophos-ethyl

Bromopropylate

Bronopol

Butachlor

Butocarboxim

Butoxycarboxim

Butylate

Calcium carbonate (aka chalk)

Calcium hydroxide (aka slake lime)

Calcium oxide (quick lime)

Carbon disulfide

Carbophenothion

Cartap

Cetrimide

Chinomethionat (aka quinomethionate)

Chlomethoxyfen

Chloral-bis-acylal

Chloral-semi-acetal

Chloramben

Chlorbromuron

Chlorbufam

Chloretazate

Chlorfenprop

Chlorfenson (aka chlorfenizon)

Chlorfenvinphos

Chlorfluazuron

Chlormephos

Chlorobenzilate

Chloropropylate

Chloroxuron

Chlorphonium chloride

Chlorthiamid

Chlorthiophos

Cufraneb

Cyanazine

Cycloate

Cycluron

Cyprofuram

DADZ (zinc-diethyldithiocarbamate)

Dalapon

delta-endotoxin of Bacillus thuringiensis

Demeton-S-methyl

Demeton-S-methyl sulphone

Desmetryne

Diafenthiuron

Dialifos

Di-allate

Diammonium phosphate

Dichlofenthion

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Dichlofluanid

Dichlone

Dichlorprop

Diclobutrazol

Dicrotophos

Dicyclopentadiene

Dienochlor

Diethatyl (-ethyl)

Difenoxuron

Difenzoquat

Dikegulac

Dimefox

Dimefuron

Dimepiperate

Dimethirimol

Dimexano

Dinitramine

Dinobuton

Dioxacarb

Dioxathion

Diphenamid (aka difenamide)

Disodium octaborate tetrahydrate

Disulfoton

Ditalimfos

Drazoxolon

Endothal

EPTC (ethyl dipropylthiocarbamate)

Etacelasil

Ethidimuron (aka sulfodiazol)

Ethiofencarb

Ethion (aka diethion)

Ethirimol

Ethoate-methyl

Etrimfos

Fenaminosulf

Fenazaflor

Fenfuram

Fenoprop

Fenothiocarb

Fenoxaprop

Fenpiclonil

Fenpropathrin

Fenridazon

Fenson (aka fenizon)

Fenthiosulf

Fenuron

Flamprop

Fluazifop

Flubenzimine

Flucycloxuron

Flucythrinate

Flumequine

Flumethralin

Fluorodifen

Fluoroglycofene

Flupoxam

Fluridone

Fomesafen

Fonofos

Formothion

Fosamine

Fosthietan

Furalaxyl

Furathiocarb

Furconazole

Furfural

Furmecyclox

Gentian violet

Halfenprox (aka brofenprox)

Haloxyfop

Heptenophos

Hexachlorophene

Hexazinone

Hydramethylnon

Hydroxy-MCPA

Hydroxyphenyl-salicylamide

Imazapyr

Imazethabenz

Iminoctadine

Iodofenphos

Isazofos

Isocarbamide

Isofenphos

Isolan

Isopropalin

Isoprothiolane

Isoxathion

Karbutilate

Kinoprene

Mancopper

Mecarbam

Mefenacet

Mephospholan

Mepronil

Merphos (aka tributylphosphorotrithioite)

Methacrifos

Methazole

Methfuroxam

Methoprene

Methoprothryne

Methoxychlor

Methylenebisthiocyanate

Methylisothiocyanate

Methylnaphthylacetamide

Methylnaphthylacetic acid

Metobromuron

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Metolachlor

Metoxuron

Metsulfovax

Mevinphos

Monalide

Monocrotophos

Monuron

MAA (methyl arsonic acid)

Nabam

Naptalam

Naphtylacetic acid hydrazide

Neburon

Nitralin

Nitrothal

Nonylphenol ether polyoxyethyleneglycol

Nonylphenol ethoxylate

Norflurazon

Noruron

Octhilinone

Ofurace

Omethoate

Orbencarb

Oxadixyl

Oxine-copper

Oxycarboxin

Oxytetracycline

Paraformaldehyde

p-Chloronitrobenzene

Pebulate

Pentachlorophenol

Pentanochlor

Perfluidone

Phenols

Phenothrin

Phenthoate

Phorate

Phosametine

Phosphamidon

Pirimiphos-ethyl

Potassium silicate

Profenofos

Promecarb

Prometryne

Propazine

Propetamphos

Propoxur

Propyl-3-t-butylphenoxyacetate

Prothiocarb

Prothiofos

Prothoate

Pyraclofos

Pyrazoxyfen

Pyridafenthion

Pyrifenox

Pyroquilone

Quinalphos

Quizalofop

Resmethrin

Rock powder

Secbumeton
Seconal (aka 5-allyl-5-(1(cid:1)-methylbutyl) barbituric acid)
Sethoxydim

Siduron

Silicates

Silver nitrate

Sodium arsenite

Sodium diacetoneketogulonate

Sodium dichlorophenate

Sodium dimethyldithiocarbamate

Sodium dioctyl sulfosuccinate

Sodium fluosilicate

Sodium monochloroacetate

Sodium pentaborate

Sodium p-t-amylphenate

Sodium silicate

Sodium silver thiosulphate

Sodium tetrathiocarbamate

Sodium thiocyanate

Sulfotep

Sulprofos

Tar acids

TCA

TCMTB

Tebutam (aka butam)

Tebuthiuron

Temephos

Terbacil

Terbufos

Terbumeton

Terbutryn

Tetrachlorvinphos

Tetradifon

Tetramethrin

Tetrasul

Thiazafluron

Thiazopyr

Thiocyclam

Thiofanox

Thiometon

Thionazin

Thiophanate

Tiocarbazil

Tolylphtalam

Tralomethrin

Triapenthenol

Triazbutyl

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Triazophos

Tribufos (s,s,s-tributyl-phosphorotrithioate)

Tributyltinoxyde

Trichloronate

Tridiphane

Trietazine

Trifenmorph

Triforine

Trioxymethylen

Validamycin

Vamidothion

Vernolate

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ANNEX II

List of authorisations referred to in Article 2(3)

Column A

Column B

Active substance

Member State

Column C

Use

2-aminobutane

United Kingdom

Stored seed potato

Ireland

Stored seed potato

1,3-dichloropropene (cis)

The Netherlands

flower bulbs, strawberries, vegetables,
replanting of orchards

tree nursery crops, perennials and

4-CPA (4-chlorophenoxyacetic acid)

Greece

Spain

Italy

Grape (seedless)

Tomato, aubergine

Soybean

Acifluorfen

Azaconazole

Benfuresate

Bromacil

Bromopropylate

Cartap

Chinomethionate

Chlorfenvinfos

Belgium

Sweet pepper, tomato, arboriculture

The Netherlands

Tomato

United Kingdom

Ornamentals

Spain

France

Belgium

Spain

Italy

Greece

Spain

Denmark

Germany

Ireland

France

Cotton

Lavender,

lavandin

Bean

Lemon, tomato, pome fruit, vine

Pome fruit, stone fruit, tomato, aubergine, pepper, melon, marrow, ornamen-
tals

Melon, water melon

Cucurbitaceae

Cabbage

Small radish, radish, carrot, onion, celery, cabbage, cucumber

Carrot, parsnip, cabbage, swede

Mushroom, asparagus, cress, radish, spinach, corn salad, gherkin, courgette,
leek, celery, parsley, garlic, cabbage, turnip
onion, shallot, carrot, celeriac,

The Netherlands

Cabbage, onion, carrot, brassica vegetables, swede, turnip, radish, black radish,
leek, celeriac

Spain

Brassicas

Cyanazine

United Kingdom

Pea, bean, brassica, narcissi, oilseed rape, Allium, forestry

Ethion

Dikegulac

Dinobuton

Ireland

France

Germany

Spain

Onion

Carrot, parsley, celery, celeriac, garlic, shallot, onion,

leek, cabbage

Ornamentals (under glass)

Pome fruit

Ethyl dipropylthiocarbamate (EPTC)

Portugal

Potato

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Column A

Column B

Active substance

Member State

Column C

Use

Fenpropathrin

United Kingdom

Soft fruit (blackcurrant)

United Kingdom

Pea, bean, spinach

United Kingdom

Pea, bean,

lupin

France

Italy

Ireland

Belgium

Denmark

Ireland

Austria

France

Ireland

Spain

Ireland

Austria

Belgium

Germany

Belgium

France

Ireland

Soybean, bean

Soybean, bean, pea

Ornamentals

Leek

Seed grass fields of red fescue, seed beds of ornamentals

Ornamentals, cucumber, tomato,

lettuce

Conifer

Conifer,

lavender,

lavandin, clary sage,

liquorice,

lucerne, sugar cane

Conifer

Conifer,

lucerne

Forestry

Lettuce

Lambs lettuce, bean, potato

Lambs lettuce, bean, tobacco

Carrot, potato

Carrot

Carrot

Luxembourg

Carrot, potato

The Netherlands

Carrot, potato,

iris, gladiolus

United Kingdom

Carrot

Fenuron

Fomesafen

Furalaxyl

Furathiocarb

Haloxyfop

Heptenophos

Hexazinone

Imazapyr

Mepronil

Metobromuron

Metoxuron

Naptalam

Omethoate

Orbencarb

Oxadixyl

Spain

France

Austria

Austria

Belgium

Melon, water melon

Melon

Ornamentals

Lupin

Pea — seed treatment

Ornamentals

Ornamentals

Ornamentals, flowers

Ornamentals

Turf grass

Tobacco

Oxycarboxin

United Kingdom

Austria

Greece

Spain

Ireland

Greece

Pebulate

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Column A

Column B

Active substance

Member State

Column C

Use

Pentanochlor

Prometryn

United Kingdom

Umbellifers, herbs

United Kingdom

Umbellifers, Allium, herbs

Pyridafenthion

Resmethrin

Sethoxydim

Spain

Greece

Ireland

France

Spain

Cotton

Cotton

Carrots, parsley, celery, parsnips

Celery, celeriac,

lentils,

leek

Vine, meadow,

lemon

United Kingdom

Mushroom

Austria

Belgium

Italy

Strawberry

Leek, beans, cabbage

Vegetables

Silver nitrate

The Netherlands

Cucumber and gherkin grown for seed

Sodium monochloracetate

United Kingdom

Brassica, Allium, soft fruit, hop

Ireland

Cabbage, Brussels sprouts, kale

Sodium silver thiosulphate

Denmark

Cut flowers, pot plants

Terbacil

Terbufos

Terbutryn

Tetradifon

Triazophos

Triforine

Vamidothion

Spain

France

Greece

Mentha

Arnica, ribbed melilot, balm, peppermint, oregano, wild pansy, rosemary,
winter savory, sage, thyme

Aromatic plants

United Kingdom

Aromatic and pharmaceutical plants

Germany

Sugar beet, fodder beet

United Kingdom

Pea, bean,

lupin

Spain

Ireland

Ireland

Austria

Denmark

Belgium

Spain

Italy

Portugal

Citrus, Cucurbitaceae, tomato, grapes

Tomato, cucumber, ornamentals nursery stock

Carrot

Bean, cucumber, ornamentals growing, rose

Apple, pear, blackcurrant, red currant, gooseberry

Apple, arboriculture

Pome fruit

Pome fruit

Apple, pear