2007/442/EC: 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)
Date: 2007-06-21
Institutions: European Commission
Subjects: dangerous substance, market approval, marketing restriction, pharmaceutical product, plant health legislation, plant health product

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(Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory)

II

DECISIONS

COMMISSION

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,

(3)

Having regard to the Treaty
Community,

establishing the European

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:

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.

(1)

(2)

Regulation (EC) No 2229/2004 provides producers in the
Czech Republic,
in Estonia, Cyprus, Latvia, Lithuania,
Hungary, Malta, Poland, Slovenia and Slovakia, with the
the
opportunity to participate in the fourth stage of
programme of work and organises
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.

the

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

this

(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.

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.

(6)

(7)

(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.

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

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

authorisations

States

for

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(8)

(9)

(10)

(11)

those active substances information has
For some of
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 authori-
sations while providing for strict conditions aimed at
minimising any possible risk.

to provide

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,
is
for
a period of grace
for
reasonable
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.

it

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.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

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.

Member States shall ensure that:

Article 2

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,
the
shall
in particular, under
measures taken under paragraph 1, and,
points (a) to (d), by 31 December of each year.

inform the Commission about

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.

This Decision is addressed to the Member States.

Article 5

(a) authorisations

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

Done at Brussels, 21 June 2007.

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

For the Commission

Markos KYPRIANOU
Member of the Commission

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

ANNEX I

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)

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

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

Polymer of styrene and acrylamide

Fatty Acids/Valeric acid

Folic acid

Formic acid

Garlic pulp

Gelatine

Iron pyrophosphate

Lanolin

Repellent
grade/phosphoric acid and fish flour

(by taste) of vegetal and animal origin/extract of

food

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

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Part B

1 Methoxy-4-propenylbenzene (Anethole)

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

Part D

Brodifacum

Chloralose

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

Chlorophacinone

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

Tricalcium phosphate

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)

Part F

Formaldehyde

Glutaraldehyde

HBTA (High Boiling Tar Acid) Notified as Disinfectant

Hydrogen peroxide

Peracetic acid

Phoxim

Sodium p-toluenesulphon-chloramide

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

Part G

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

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

Neodiprion sertifer nuclear polyhedrosis virus

N-phenylphthalamic acid

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ANNEX II

List of authorisations referred to in Article 3(1)

Column A

Active substance

Column B

Member State

Column C

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

extract used as plant

Plant
regulator
cereals,
on
orchards, vineyards, citrus
mentals and forestry.

growth
vegetables,
fruit, orna-

Citrus extract/grapefruit extract (Group A)

Poland

Vegetables, ornamental crops and seed
treatment,
indoor
disinfection
equipment.

of

EDTA and salts thereof (Group A)

Poland

Trees in nurseries.

Extract from mentha piperata (Group A)

Poland

Seed treatment in pre-sowing phase.

from plants Red oak, Pronikly
Extract
pear
Red
cactus,
mangrove (Group A)

Fragrant

sumac,

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

Germany

Blackcurrant and fruiting vegetables.

Ornamentals, orchards,
spices, herbs and vegetables.

small berries,

Paraffin oil (CAS 64741-88-4) (Group A)

Poland

Seed potato crop.

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Column A

Active substance

Column B

Member State

Column C

Use

Paraffin oil (CAS 8012-95-1) (Group A) Hungary

Fruit trees, grapevine, pepper, cucumber,
sugar beet, ornamentals and berries.

Spain

Plants oils/Orange oil (Group A)

Poland

Cereals.

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,
minous crops.

legu-

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

2,6,6,-trimethylbicyclo [3.1.1] hept
2-ene (alpha-Pinen) (Group B)

Poland

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

Poland

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

Poland

Forest plantations.

Forest plantations.

Forest plantations.

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)

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

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

Poland

Poland

Poland

Forest plantations.

Forest plantations.

Forest plantations.

Methyl p-hydroxybenzoate (Group B)

Poland

Forest plantations.

Brodifacum (Group D)

Germany, Spain

appropriately

Rodenticide: limited to pre-prepared baits
if
specially
constructed hoppers. Limited to profes-
sional users with appropriate protective
equipment.

placed

in

Poland

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

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Column A

Active substance

Column B

Member State

Column C

Use

Chloralose (Group D)

France

Chlorophacinone (Group D)

France, Germany, Spain

Glutaraldehyde (Group F)

Belgium

France

Poland

Hydrogen peroxide (Group F)

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.

Rodenticide: use limited to pre-prepared
baits if appropriately placed in specially
constructed hoppers. Limited to profes-
sional users with appropriate protective
equipment.

agricultural

Limited to professional users with appro-
priate protective equipment. Disinfection
transportation
tools,
of
empty mushroom growing
vehicles,
rooms, empty storage warehouses
for
plant products.

Limited to professional users with appro-
priate protective equipment. Disinfection
of empty storage warehouses for plant
products and of agricultural tools.

Limited to professional users with appro-
priate protective equipment. Disinfection
of
transportation
tools,
vehicles, empty storage warehouses for
plant products and greenhouses.

agricultural

Disinfection of glasshouses, agricultural
equipments and irrigation pipes.

The Netherlands

Flowers bulbs and chicory.

United Kingdom

Peracetic acid (Group F)

France

Flower bulbs, potato tubers and disin-
fection of glasshouses, warehouses and
agricultural tools and equipments.

Disinfection of glasshouses, agricultural
equipments and irrigation pipes.

Poland

Disinfection of glasshouses, warehouses
and agricultural tools and equipments.

The Netherlands

Flower bulbs.

United Kingdom

Phoxim

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

Slovenia

Poland

Flower bulbs, potato tubers and disin-
fection of glasshouses, warehouses and
agricultural tools and equipments.

Insecticide used in soil application.

Equipment, greenhouses, machines and
other agricultural tools.

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Column A

Active substance

Column B

Member State

Column C

Use

Hexamethylene tetramin (Group G)

Slovak Republic

Forest plantations.

Bio humus (Group G)

Flufenzin (Group G)

Poland

Hungary

Ethanedial (glyoxal) (Group G)

Poland

N- phenylphthalamic acid (Group G)

Hungary

Ornamental plants and plant enhancer.

Fruit trees, grapevine, berries, vegetables
and ornamental trees.

Limited to professional users with appro-
priate protective equipment. Disinfection
transportation
tools,
of
vehicles, greenhouses and empty storage
warehouses for plant products.

agricultural

sunflower,

Vegetables,
alfalfa,
lupine, crimson-clover, rape, rice, sour-
cherry, apple and grape-vine.

soya,