BUCTRIL MA

Main information

  • Trade name:
  • BUCTRIL MA SELECTIVE HERBICIDE
  • Pharmaceutical form:
  • Emulsifiable
  • Units in package:
  • 20L, 110L, 200L, 1000L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • BAYER CROPSCIENCE

Documents

Localization

  • Available in:
  • BUCTRIL MA SELECTIVE HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BARLEY | CEREAL RYE | GRASS PASTURE | LINSEED OIL CROP | OATS | TRITICALE | WHEAT
  • Therapeutic area:
  • Group CI Herbicide
  • Therapeutic indications:
  • AMSINCKIA,YELLOW BURRWEED OR BURR GRASS | BLACK BINDWEED | CAPEWEED | CHAMOMILE OR MATRICARIA | CHARLOCK | CLEAVERS | COMMON PEPPERCRESS | CORN GROMWELL, IRONWEED OR SHEEPWEED | FAT HEN | FIELD MADDER | FUMITORY | HORNED POPPY | INDIAN HEDGE MUSTARD | LESSER SWINECRESS OR BITTERCRESS | MELILOTUS OR HEXHAM SCENT | MEXICAN OR PRICKLY POPPY | MINTWEED | MOUNTAIN SORREL/PURPLE CALANDRINIA | MUSTARD | PATERSON'S CURSE | ROUGH POPPY | SAFFRON THISTLE | SHEPHERD'S PURSE | SLENDER, SHORE OR SHEEP THISTLE | THREE CORNERED JACK OR DOUBLEGEE | THREE-HORNED BEDSTRAW | TREE HOGWEED | TURNIP WEED | VARIEGATED THISTLE | WILD RADISH OR RADISH WEED | WILD TURNIP | WIREWEED, KNOTWEED OR HOGWEED | AMSINCKIA ANGUSTIFOLIA | AMSINCKIA CALYCINA | AMSINCKIA HISPIDA | AMSINCKIA INTERMEDIA | AMSINCKIA LYCOPSOIDES | ANNUAL BINDWEED | ARGEMONE OCHROLEUCA | BILDERDYKIA CONVOLVULUS | BLESSED THISTLE | BLUE FIELD MADDER | BLUE SALVIA | BRASSICA CAMPESTRIS | BRASSICA KABER | BRASSICA RAPA SSP. SYLVESTRIS | BRASSICA RAPA VAR. SYLVESTRIS | BR
  • Product summary:
  • For the control of broadleaf weeds in cereals, linseed and grass pastures.See Restraints on label also

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 31466/0410
  • Authorization date:
  • 04-05-2010
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

20 L

I

MPORTANT: READ THE

ATTACHED BOOKLET BEFORE USE.

MN 79000000

/ LABSC79000000A

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

For the control of

broadleaf weeds in cereals,

linseed and grass pastures as

specified in the DIRECTIONS FOR USE Table

ACTIVE CONSTITUENTS:

200 g/L BROMOXYNIL present as the octanoate

200 g/L MCPA present as the ethyl hexyl ester

SOLVENT:

340 g/L LIQUID HYDROCARBON

C

HERBICIDE

GROUP

Buctril

®

MA

31466_XXXXX_20L Front_MPL_V1_size 220mm (w) x 240mm (d) print A3 @ 100%

APPROVED

LABEL

Info

pest

Verified

FOR 24 HOUR

SPECIALIST ADVICE

IN EMERGENCY

ONLY

PHONE

180

0 033 111

Bayer CropScience Pty Ltd

A.B.N. 87 000 226 022

391-393 Tooronga Rd

East Hawthorn, Vic. 3123

Phone: (03) 9248 6888

Fax: (03) 9248 6800

www.bayercropscience.com.au

Technical Enquiries: 1800 804 479

Batch No.:

D.O.M.:

STORAGE AND DISPOSAL

Store in the closed, original container in a dry, cool, well-ventilated area

out of direct sunlight.

Triple or preferably pressure rinse containers before disposal. Add rinsings

to spray tank. Do not dispose of undiluted chemicals on site.

If recycling, replace cap and return clean containers to recycler or desig-

nated collection point. If not recycling, break, crush, or puncture and bury

empty containers in a local authority landfill. If no landfill is available, bury

the containers below 500 mm in a disposal pit specifically marked and

set up for this purpose clear of waterways, desirable vegetation and tree

roots. Empty containers and product should not be burnt. Do not re-use

empty containers for any other purpose.

SAFETY DIRECTIONS

Product is poisonous if inhaled or swallowed. Attacks the eyes. Will irritate

the skin. Avoid contact with eyes and skin. Do not inhale spray mist.

When preparing the spray and using the prepared spray wear cotton

overalls buttoned to the neck and wrist, a washable hat, elbow-length

PVC gloves and face shield or goggles. If product in eyes, wash it out

immediately with water. After use and before eating, drinking or smoking,

wash hands, arms and face thoroughly with soap and water. After each

day’s use, wash gloves, face shield or goggles and contaminated clothing.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre

(telephone 13 11 26).

If swallowed, do NOT induce vomiting. Give a glass of water.

MATERIAL SAFETY DATA SHEET

Additional information is listed in the Material Safety Data Sheet, which

can be obtained from www.bayercropscience.com.au.

EXCLUSION OF LIABILITY

This product must be used strictly as directed, and in accordance with

all instructions appearing on the label and in other reference material. So

far as it is lawfully able to do so, Bayer CropScience Pty Ltd accepts no

liability or responsibility for loss or damage arising from failure to follow

such directions and instructions.

Buctril

is a Registered Trademark of Bayer.

APVMA Approval No.: 31466/20/0410

319784 240375

LABMC79000000A

T.B.A.

Buctril

®

MA

31466_XXXXX_20L Back_MPL_V1_size 220mm (w) x 240mm (d) print A3 @ 100%

APPROVED

LABEL

GENERAL INSTRUCTIONS

Resistant Weeds Warning

Buctril MA Selective Herbicide is a member of the nitrile and phenoxy groups of herbicides. Buctril MA has both the inhibitor

of photosynthesis at photosystem II and disruptor of plant cell growth modes of action. For weed resistance management

Buctril MA is a Group C and I herbicide. Some naturally occurring weed biotypes resistant to Buctril MA and other Group C

and I herbicides may exist through normal genetic variability in any weed population.

The resistant individuals can eventually dominate the weed population if these herbicides are used repeatedly. These resist-

ant weeds will not be controlled by Buctril MA or other Group C and I herbicides. Since the occurrence of resistant weeds is

difficult to detect prior to use, Bayer CropScience Pty Ltd accepts no liability for any losses that may result from the failure of

Buctril MA to control resistant weeds.

Note

Maximum daily temperatures at or above 20°C at application, or on days following treatment, may result in seedling

mortality and established plants may be damaged.

Application

Mixing: To ensure even mixing, half fill the spray tank with clean water and add the required amount of product.

Agitate thoroughly, then add the remainder of the water. Agitate again before spraying commences.

Boom Sprayer: Calibrate the machine before use to ensure that the correct application rate is obtained. Check height

of boom above the crop to ensure that the spray is evenly distributed. Wash the spray equipment thoroughly after use.

Cereals: Apply 50 to 200 litres of water per hectare. A minimum of 160 litres and preferably 200 litres of water per hectare is

recommended where the weed infestation is heavy or the crop cover is dense. Complete coverage of weeds

is essential.

Linseed: Apply a minimum of 220 litres of water per hectare.

Aerial Application: Apply a minimum of 22 litres of water per hectare. Markers should always move upwind before

aircraft passes overhead. Application by micronaire equipment may give variable results.

Compatibility

This product is physically compatible in the spray tank with one of the following herbicides and insecticides in wheat and

barley only: Ally

, chlorpyrifos, dicamba, dimethoate, endosulfan, Hoegrass

, MCPA and omethoate. When mixed with Ally or

dicamba, do not apply to cereals undersown with lucerne. When mixed with Hoegrass, do not exceed 1.4 litres

of this product per hectare. Observe all instructions on the mixture partner label. As formulations of other manufacturers’

products are beyond the control of Bayer CropScience, all mixtures should be tested prior to mixing commercial

quantities.

PROTECTION OF LIVESTOCK

Grazing Precaution

Sprayed weeds may become more palatable to stock and a higher intake of some weeds may result in stock poisoning

and death from causes such as nitrate poisoning. Care should be taken especially where capeweed, Paterson’s curse and

variegated thistles predominate in the pasture. Avoid grazing with young or breeding stock. Do not graze horses or pigs on

Paterson’s curse. If in doubt, contact your nearest Department of Agriculture.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET PLANTS

DO NOT apply under weather conditions or from spraying equipment which could be expected to cause spray to drift onto

nearby plants, adjacent crops, crop lands or pastures. Avoid spray drift and vapour movement onto susceptible crops such as

cotton, tobacco, tomatoes, vines, lupins, fruit trees and ornamentals. DO NOT apply by misting machines.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT

Dangerous to fish. DO NOT contaminate streams, rivers or waterways with the chemical or used containers.

STORAGE AND DISPOSAL

Store in the closed, original container in a dry, cool, well-ventilated area out of direct sunlight.

Triple or preferably pressure rinse containers before disposal. Add rinsings to spray tank. Do not dispose of undiluted

chemicals on site. If recycling, replace cap and return clean containers to recycler or designated collection point. If not

recycling, break, crush, or puncture and bury empty containers in a local authority landfill. If no landfill is available, bury

the containers below 500 mm in a disposal pit specifically marked and set up for this purpose clear of waterways,

desirable vegetation and tree roots. Empty containers and product should not be burnt. Do not re-use empty containers

for any other purpose.

SAFETY DIRECTIONS

Product is poisonous if inhaled or swallowed. Attacks the eyes. Will irritate the skin. Avoid contact with eyes and skin.

Do not inhale spray mist. When preparing the spray and using the prepared spray wear cotton overalls buttoned to the neck

and wrist, a washable hat, elbow-length PVC gloves and face shield or goggles. If product in eyes, wash it out immediately

with water. After use and before eating, drinking or smoking, wash hands, arms and face thoroughly with soap and water.

After each day’s use, wash gloves, face shield or goggles and contaminated clothing.

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information Centre (telephone 13 11 26). If swallowed, do NOT induce

vomiting. Give glass of water.

MATERIAL SAFETY DATA SHEET: Additional information is listed in the Material Safety Data Sheet, which can be

obtained from www.bayercropscience.com.au.

EXCLUSION OF LIABILITY

This product must be used strictly as directed, and in accordance with all instructions appearing on the label and in other

reference material. So far as it is lawfully able to do so, Bayer CropScience Pty Ltd accepts no liability or responsibility

for loss or damage arising from failure to follow such directions and instructions.

APVMA Approval No.: 31466/200/1209

Buctril

and Hoegrass

are Registered Trademarks of Bayer

WA only

Qld, NSW, Vic,

Tas, SA, NT,

ACT only

WA only

All States

Qld, NSW, Vic, SA,

Tas only

WA only

Qld, NSW, Vic,

Tas, SA, NT,

ACT only

WA only

Qld, NSW, Vic,

Tas, SA, NT,

ACT only

WA only

DIRECTIONS FOR USE

Restraints:

apply if crop, pasture or weeds are stressed due to dry or excessively moist conditions.

DO NOT apply to diseased or frost-affected crops or if frosts are imminent.

DO NOT apply if rain is expected within three hours.

CROP/

SITUATION

WEEDS CONTROLLED

STATE

RATE

CRITICAL COMMENTS

Wheat,

Barley,

Cereal Rye, Oats

and Triticale

Linseed

Grass Pastures

Amsinckia

Capeweed

Chamomile

Charlock

Corn Gromwell

(Ironweed, Sheepweed)

Fat Hen

Field Madder

Hexham Scent

(King Island Melilot)

Horned Poppy

Indian Hedge Mustard

Lesser Swinecress

Mexican Poppy

Mintweed

Paterson’s Curse (Salvation

Jane)

Rough Poppy

Saffron Thistle

Shepherd’s Purse

Slender Thistles

Tree Hogweed

Turnip Weed

(Giant Mustard)

Wild Radish

Wild Turnip

Black Bindweed

(Climbing Buckwheat)

Common Peppercress

Mustards

Purple Calandrinia

Fumitory

Threecornered Jack

(Doublegee, Spiny Emex)

Variegated Thistle

Wireweed (Hogweed)

Mountain Sorrel

Three-horned Bedstraw

Cleavers

750 mL/ha

1.4 L/ha

2.0 L/ha

1.4 L/ha

1.0 L/ha

1.4 L/ha

2.0 L/ha

1.4 L/ha

750 mL/ha

2.0 L/ha

1.4 L/ha

750 mL/ha

1.4 L/ha

2.0 L/ha

1.4 L/ha

750 mL/ha

1.4 L/ha

750 mL/ha

CROP STAGE:

Wheat, Barley, Cereal Rye, Oats and Triticale:

3 leaf to fully tillered stage (Zadok Scale Z13-30) for rates of 750 mL to 1.4 L/ha;

5 leaf to fully tillered stage (Z15-30) for rate of 2.0 L/ha (NSW, Vic, SA, WA, Tas only);

or early tillering to fully tillered stage (Z21-30) (Qld only).

Linseed: 50 to 150 mm high. DO NOT apply to linseed by aircraft.

If spraying Black Bindweed when wheat, barley, cereal rye, oats, triticale or linseed is

more than 300 mm high, increase spray volume to 200 L/ha.

For optimal control, apply only when the weeds are actively growing.

In the early stages following spraying, temporary wilting of crop and pasture may occur.

Crop scorch may occur, particularly on oats, if treatment is delayed to later stages of

growth.

Refer to the General Instructions.

Avoid application when maximum daily temperatures above 20°C occur, or are likely to occur

for a few days after application.

DO NOT apply to crops or pastures undersown with lucerne, clover or medics

unless some damage is acceptable.

CROP STAGE:

Wheat, Barley, Cereal Rye, Oats and Triticale:

3 leaf to fully tillered stage (Zadok Scale Z13-30) for rates of 750 mL to 1.4 L/ha;

5 leaf to fully tillered stage (Z15-30) for rate of 2.0 L/ha (NSW, Vic, SA, WA, Tas only);

or early tillering to fully tillered stage (Z21-30) (Qld only).

Linseed: 50 to 150 mm high. DO NOT apply to linseed by aircraft.

For optimal control, apply only when the weeds are actively growing.

In the early stages following spraying, temporary wilting of crop and pasture may occur.

Crop scorch may occur, particularly on oats, if treatment is delayed to later stages of

growth.

Refer to the General Instructions.

Avoid application when maximum daily temperatures above 20°C occur, or are likely to occur

for a few days after application.

DO NOT apply to crops or pastures undersown with lucerne, clover or medics

unless some damage is acceptable.

Where Wireweed occurs in red soils of low fertility, it has been found to be less

susceptible. In these circumstances use 2.0 L/ha.

Batch No.:

D.O.M.

Bayer CropScience Pty Ltd

A.B.N. 87 000 226 022

391-393 Tooronga Rd

East Hawthorn, Vic. 3123

Phone:

(03) 9248 6888

Fax:

(03) 9248 6800

www.bayercropscience.com.au

Technical Enquiries:

1800 804 479

FOR 24 HOUR

SPECIALIST

ADVICE IN

EMERGENCY

ONLY

PHONE

1800 033 111

STAGE OF WEED GROWTH

Plants up to the 6 leaf stage but not

more than 50 mm in diameter

Plants up to the 8 leaf stage but not

more than 75 mm in diameter

Plants up to the 4 leaf stage but not

more than 35 mm in diameter

Plants up to the 6 leaf stage but not

more than 50 mm in diameter

Plants up to the 8 leaf stage but not

more than 75 mm in diameter

Plants up to the 3 leaf stage but not

more than 50 mm in diameter

Plants up to the 4 leaf stage but not

more than 60 mm in diameter

Plants up to the 5 leaf stage but not

more than 75 mm in diameter

Plants up to the 6 leaf stage but not

more than 85 mm in diameter

Plants up to the 4 leaf stage but not

more than 35 mm in diameter

Plants up to the 6 leaf stage but not

more than 50 mm in diameter

Plants up to the 6 leaf stage

Plants up to the 8 leaf stage

2-4 stem stage and 1-3 whorls

of leaves per stem

(Amsinckia spp.)

(Arctotheca calendula)

(Matricaria matricarioides)

(Sinapis arvensis)

(Buglossoides arvensis)

(Chenopodium album)

(Sherardia arvensis)

(Melilotus indica)

(Glaucium flavum)

(Sisymbrium orientale)

(Coronopus didymus)

(Argemone ochroleuca)

(Salvia reflexa)

(Echium plantagineum)

(Papaver hybridum)

(Carthamus lanatus)

(Capsella bursa-pastoris)

(Carduus tenuiflorus,

C. pycnocephalus)

(Polygonum patulum)

(Rapistrum rugosum)

(Raphanus raphanistrum)

(Brassica tournefortii)

(Fallopia convolvulus)

(Lepidium africanum)

(Sisymbrium spp.)

(Calandrinia menziesii)

(Fumaria spp.)

(Emex australis)

(Silybum marianum)

(Polygonum aviculare)

(Oxalis acetosella)

(Galium tricornutum)

(Galium aparine)

NOT TO BE USED FOR ANY PURPOSE OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION

WITHHOLDING PERIOD

Harvest

Cereals, linseed: NOT REQUIRED WHEN USED AS DIRECTED

Grazing

Cereals, pasture: DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 8 WEEKS AFTER APPLICATION.

200 L

Size

600mm wide x 250 mm deep

Print

4 color process

GROUP

HERBICIDE

C I

9 319784 975154

Thiodan EC

INSECTICIDE

BCSBF8A SIZE: 210 mm wide x 250 mm deep

Buctril

®

MA

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

For the control of

broadleaf weeds in cereals,

linseed and grass pastures as

specified in the DIRECTIONS FOR USE Table

C

I

HERBICIDE

GROUP

Buctril

®

MA

MN 6519385 - LBL 6518893/1209

ACTIVE CONSTITUENTS:

200 g/L BROMOXYNIL present as the octanoate

200 g/L MCPA present as the ethyl hexyl ester

SOLVENT:

340 g/L LIQUID HYDROCARBON

31466_49202_200L label_MPL_V1_size 600mm (w) x 250mm (d) print A3 @ 67%

APPROVED

LABEL

Bayer CropScience Pty Ltd

A.B.N. 87 000 226 022

391-393 Tooronga Rd

East Hawthorn Vic. 3123

Phone: (03) 9248 6888

Fax: (03) 9248 6800

www.bayercropscience.com.au

Technical enquiries: 1800 804 479

ACTIVE CONSTITUENTS:

200 g/L BROMOXYNIL present as the octanoate

200 g/L MCPA present as the ethyl hexyl ester

SOLVENT:

340 g/L LIQUID HYDROCARBON

For the control of broadleaf weeds in cereals, linseed and grass pastures as specified in the

DIRECTIONS FOR USE table

STORAGE AND DISPOSAL

Store in the closed, original container in a dry, cool, well-ventilated area out of direct sunlight.

The method of disposal of the container depends on the container type. Read the ‘Storage and

Disposal’ instructions on the label that is attached to the container.

SAFETY DIRECTIONS

Product is poisonous if inhaled or swallowed. Attacks the eyes. Will irritate the skin. Avoid contact

with eyes and skin. Do not inhale spray mist.

When preparing the spray and using the prepared spray wear cotton overalls buttoned to the neck

and wrist, a washable hat, elbow-length PVC gloves and face shield or goggles. If product in eyes,

wash it out immediately with water. After use and before eating, drinking or smoking, wash hands,

arms and face thoroughly with soap and water. After each day’s use, wash gloves, face shield or

goggles and contaminated clothing.

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information Centre (telephone 13 11 26).

If swallowed, do NOT induce vomiting. Give glass of water.

MATERIAL SAFETY DATA SHEET

Additional information is listed in the Material Safety Data Sheet, which can be obtained from

www.bayercropscience.com.au.

EXCLUSION OF LIABILITY

This product must be used strictly as directed, and in accordance with all instructions

appearing on the label and in other reference material. So far as it is lawfully able to do so,

Bayer CropScience Pty Ltd accepts no liability or responsibility for loss or damage arising from

failure to follow such directions and instructions.

APVMA Approval No.: 31466/1209

Buctril

is a Registered Trademark of Bayer

IMPORTANT: READ THIS BOOKLET BEFORE USE

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

79432070B/1209

Size

100 mm wide x 168mm deep (folded)

Print

2 PMS colors

Black

PMS 166 C

GENERAL INSTRUCTIONS

Resistant Weeds Warning

Buctril MA Selective Herbicide is a member of the nitrile and phenoxy groups of herbicides. Buctril MA

has both the inhibitor of photosynthesis at photosystem II and disruptor of plant cell growth modes of

action. For weed resistance management Buctril MA is a Group C and I herbicide. Some naturally

occurring weed biotypes resistant to Buctril MA and other Group C and I herbicides may exist through

normal genetic variability in any weed population. The resistant individuals can eventually dominate the

weed population if these herbicides are used repeatedly. These resistant weeds will not be controlled

by Buctril MA or other Group C and I herbicides. Since the occurrence of resistant weeds is difficult to

detect prior to use, Bayer CropScience Pty Ltd accepts no liability for any losses that may result from the

failure of Buctril MA to control resistant weeds.

Note

Maximum daily temperatures at or above 20°C at application, or on days following treatment, may result

in seedling mortality and established plants may be damaged.

Application

Mixing

To ensure even mixing, half fill the spray tank with clean water and add the required amount of product.

Agitate thoroughly, then add the remainder of the water. Agitate again before spraying commences.

Boom Sprayer

Calibrate the machine before use to ensure that the correct application rate is obtained. Check height

of boom above the crop to ensure that the spray is evenly distributed. Wash the spray equipment

thoroughly after use.

Cereals

Apply 50 to 200 litres of water per hectare. A minimum of 160 litres and preferably 200 litres of water

per hectare is recommended where the weed infestation is heavy or the crop cover is dense. Complete

coverage of weeds is essential.

Linseed

Apply a minimum of 220 litres of water per hectare.

Aerial Application

Apply a minimum of 22 litres of water per hectare. Markers should always move upwind before aircraft

passes overhead. Application by micronaire equipment may give variable results.

Compatibility

This product is physically compatible in the spray tank with one of the following herbicides and

insecticides in wheat and barley only: Ally

, chlorpyrifos, dicamba, dimethoate, endosulfan, Hoegrass

MCPA and omethoate. When mixed with Ally or dicamba, do not apply to cereals undersown with

lucerne. When mixed with Hoegrass, do not exceed 1.4 litres of this product per hectare. Observe all

instructions on the mixture partner label.

As formulations of other manufacturers’ products are beyond the control of Bayer CropScience, all

mixtures should be tested prior to mixing commercial quantities.

PROTECTION OF LIVESTOCK

Grazing Precaution

Sprayed weeds may become more palatable to stock and a higher intake of some weeds may result in

stock poisoning and death from causes such as nitrate poisoning. Care should be taken especially where

capeweed, Paterson’s curse and variegated thistles predominate in the pasture. Avoid grazing with young

or breeding stock. Do not graze horses or pigs on Paterson’s curse. If in doubt, contact your nearest

Department of Agriculture.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET PLANTS

DO NOT apply under weather conditions or from spraying equipment which could be expected to cause

spray to drift onto nearby plants, adjacent crops, crop lands or pastures. Avoid spray drift and vapour

movement onto susceptible crops such as cotton, tobacco, tomatoes, vines, lupins, fruit trees and

ornamentals. DO NOT apply by misting machines.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT

Dangerous to fish. DO NOT contaminate streams, rivers or waterways with the chemical or

used containers.

Buctril

and Hoegrass

are Registered Trademarks of Bayer.

GROUP

HERBICIDE

C I

31466_49202_Booklet_MPL_V1_size folded 100mm (w) x 168mm (d) print A3 @ 100%

DIRECTIONS FOR USE

Restraints

DO NOT apply if crop, pasture or weeds are stressed due to dry or excessively moist conditions.

DO NOT apply to diseased or frost-affected crops or if frosts are imminent.

DO NOT apply if rain is expected within three hours.

CROP/SITUATION

WEEDS CONTROLLED

STAGE OF WEED GROWTH

STATE

Wheat, Barley,

Cereal Rye, Oats

and Triticale

Linseed

Grass Pastures

Amsinckia

(Amsinckia spp.)

Capeweed

(Arctotheca calendula)

Chamomile

(Matricaria

matricarioides

Charlock

(Sinapis arvensis)

Corn Gromwell

(Buglossoides arvensis)

(Ironweed,

Sheepweed)

Fat Hen

(Chenopodium album)

Field Madder

(Sherardia arvensis)

Hexham Scent

(Melilotus indica)

(King Island Melilot)

ned Poppy

(Glaucium flavum)

Indian Hedge

(Sisymbrium orientale)

Mustard

Lesser Swinecr

(Coronopus didymus)

Mexican Poppy

(Argemone ochroleuca)

Mintweed

(Salvia reflexa)

Paterson’

s Curse

(Echium plantagineum)

(Salvation Jane)

Rough Poppy

(Papaver hybridum)

fron Thistle

(Carthamus lanatus)

Shepherd’

s Purse

(Capsella

bursa-pastoris)

Slender Thistles

(Carduus tenuiflorus,

C.pycnocephalus

ee Hogweed

(Polygonum patulum)

nip Weed

(Rapistrum rugosum)

(Giant Mustard)

Wild Radish

(Raphanus

raphanistrum

Wild Turnip

(Brassica tournefortii)

Plants up to the 6 leaf stage

but not more than

50 mm in diameter

WA only

Qld, NSW,

Vic, Tas,

SA, NT,

ACT only

Plants up to the 8 leaf stage

but not more than

75 mm in diameter

WA only

Black Bindweed*

(Fallopia convolvulus)

(Climbing

Buckwheat)

Common

(Lepidium africanum)

Peppercress

Mustar

(Sisymbrium spp.)

Purple Calandrinia

(Calandrinia menziesii)

Plants up to the 4 leaf stage

but not more than

35 mm in diameter

Plants up to the 6 leaf stage

but not more than

50 mm in diameter

All States

Plants up to the 8 leaf stage

but not more than

75 mm in diameter

RATE

CRITICAL COMMENTS

mL/ha

CROP STAGE:

Wheat, Barley, Cereal Rye, Oats and Triticale: 3 leaf to fully tillered stage (Zadok Scale Z13-30) for

rates of 750 mL to 1.4 L/ha; 5 leaf to fully tillered stage (Z15-30) for rate of 2.0 L/ha (NSW, Vic, SA, WA,

Tas only); or early tillering to fully tillered stage (Z21-30) (Qld only).

Linseed: 50 to 150 mm high. DO NOT apply to linseed by aircraft.

* If spraying Black Bindweed when wheat, barley, cereal rye, oats, triticale or linseed is more than

300 mm high, increase spray volume to 200 L/ha.

For optimal control, apply only when the weeds are actively growing.

In the early stages following spraying, temporary wilting of crop and pasture may occur.

Crop scorch may occur, particularly on oats, if treatment is delayed to later stages of growth.

Refer to the General Instructions.

Avoid application when maximum daily temperatures above 20°C occur, or are likely to occur for a few

days after application.

DO NOT apply to crops or pastures undersown with lucerne, clover or medics unless some

damage is acceptable.

1.4 L/ha

2.0 L/ha

1.4 L/ha

1.0 L/ha

1.4 L/ha

2.0 L/ha

CROP/SITUATION

WEEDS CONTROLLED

STAGE OF WEED GROWTH

STATE

Wheat, Barley,

Cereal Rye, Oats

and Triticale

Linseed

Grass Pastures

Fumitory

(Fumaria spp.)

Threecornered Jack

(Emex australis)

(Doublegee,

Spiny Emex)

Plants up to the 3 leaf stage

but not more than 50mm in

diameter

Qld, NSW,

Vic, SA,

Tas only

Plants up to the 4 leaf stage

but not more than 60mm in

diameter

WA only

Plants up to the 5 leaf stage

but not more than 75mm in

diameter

Qld, NSW,

Vic, Tas, SA,

NT, ACT

only

Plants up to the 6 leaf stage

but not more than 85mm in

diameter

WA only

Variegated Thistle

(Silybum marianum)

Wireweed

(Polygonum aviculare)

(Hogweed)**

Plants up to the 4 leaf stage

but not more than 35mm in

diameter

Qld, NSW,

Vic, Tas, SA,

NT, ACT

only

Plants up to the 6 leaf stage

but not more than 50mm in

diameter

WA only

Mountain Sorrel

(Oxalis acetosella)

Three-horned

(Galium tricornutum)

Bedstraw

Plants up to the 6 leaf stage

Plants up to the 8 leaf stage

Cleavers

(Galium aparine)

2-4 stem stage and 1-3 whorls

of leaves per stem

NOT TO BE USED FOR ANY PURPOSE OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS

AUTHORISED UNDER APPROPRIATE LEGISLATION

WITHHOLDING PERIOD

Harvest

Cereals, linseed: NOT REQUIRED WHEN USED AS DIRECTED

Grazing

Cereals, pasture: DO NOT GRAZE OR CUT FOR STOCK FOOD FOR 8 WEEKS AFTER APPLICATION.

RATE

CRITICAL COMMENTS

1.4 L/ha

CROP STAGE:

Wheat, Barley, Cereal Rye, Oats and Triticale: 3 leaf to fully tillered stage (Zadok Scale Z13-30) for

rates of 750 mL to 1.4 L/ha; 5 leaf to fully tillered stage (Z15-30) for rate of 2.0 L/ha (NSW, Vic, SA, WA,

Tas only); or early tillering to fully tillered stage (Z21-30) (Qld only).

Linseed: 50 to 150 mm high. DO NOT apply to linseed by aircraft.

For optimal control, apply only when the weeds are actively growing.

In the early stages following spraying, temporary wilting of crop and pasture may occur.

Crop scorch may occur, particularly on oats, if treatment is delayed to later stages of growth.

Refer to the General Instructions.

Avoid application when maximum daily temperatures above 20°C occur, or are likely to occur for a few

days after application.

DO NOT apply to crops or pastures undersown with lucerne, clover or medics unless some

damage is acceptable.

** Where Wireweed occurs in red soils of low fertility, it has been found to be less susceptible.

In these circumstances use 2.0L/ha.

mL/ha

2.0 L/ha

1.4 L/ha

mL/ha

1.4 L/ha

2.0 L/ha

1.4 L/ha

750 mL

1.4 L/ha

mL/ha

31466_49202_Booklet_MPL_V1_size folded 100mm (w) x 168mm (d) print A3 @ 100%

17-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

Assessment of genetically modified maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing, under Regulation (EC) No 1829‐2003 (application EFSA‐GMO‐NL‐2013‐112)

Published on: Wed, 16 Jan 2019 Maize MON 89034 × 1507 × NK603 × DAS‐40278‐9 (four‐event stack maize) was produced by conventional crossing to combine four single events: MON 89034, 1507, NK603 and DAS‐40278‐9. The GMO Panel previously assessed the four single events and four of their subcombinations and did not identify safety concerns. No new data on the maize single events or their four subcombinations that could lead to modification of the original conclusions on their safety have been identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for dazomet according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Published on: Mon, 14 Jan 2019 Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for metam according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance metam. To assess the occurrence of metam residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008C as well as the European authorisations reported by Member States (including the...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Assessment of genetically modified soybean A2704‐12 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐009)

Published on: Mon, 14 Jan 2019 Following the submission of application EFSA‐GMO‐RX‐009 under Regulation (EC) No 1829/2003 from Bayer CropScience N.V., the Panel on Genetically Modified Organisms of the European Food Safety Authority was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean A2704‐12, for food and feed uses, import and processing, excluding cultivation within th...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluometuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sedaxane according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for triazoxide according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Review of the existing maximum residue levels for chromafenozide according to Article 12 Regulation (EC) No 396/2005

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for pencycuron according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Response to comments on the Scientific Opinion on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006

Published on: Thu, 13 Dec 2018 Following a request from the European Commission, EFSA was asked to review the comments received on the Scientific Opinion of the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) on the scientific substantiation of a health claim related to Symbiosal® and lowering of blood pressure and reduced risk of hypertension pursuant to Article 14 of Regulation (EC) No 1924/2006. Comments originating from the applicant (Han‐Biotech GmbH) were submitted to EFSA via the E...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for sintofen according to Article 12 of Regulation (EC) No 396/2005

Published on: Tue, 28 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sintofen. To assess the occurrence of sintofen residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for prochloraz according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 27 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for napropamide according to Article 12 of Regulation (EC) No 396/2005

Published on: Fri, 24 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for myclobutanil according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 13 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)

The U.S. Food and Drug Administration (FDA) is warning that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. We required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when we approved the medicine in 2009. Once we receive the final results from the manufacturer, we will conduct a comprehensive review and will update the public with any new inf...

FDA - U.S. Food and Drug Administration

17-7-2018

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Blokhuis kondigt grootschalige extra vaccinatie aan: Ruim half miljoen kinderen krijgen oproep

Volgend jaar worden zo’n 650.000 kinderen extra opgeroepen om zich te laten inenten tegen de zeer ernstige infectieziekte meningokokken. Het gaat om kinderen die zijn geboren na 1 januari 2001 en voor mei 2004. Dat laat staatssecretaris Paul Blokhuis (VWS) weten in een brief aan de Tweede Kamer. Reden voor deze maatregel is dat in de afgelopen jaren een stijging te zien is van het aantal mensen dat de infectie meningokokken type W oploopt. Met deze extra vaccinatieronde moet die groei worden ingedamd. He...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

29-3-2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

New reimbursement status of lipid lowering medicinal products enters into force on 23 April 2007

As of 23 April 2007, the reimbursement status of lipid lowering medicinal products will be changed. The decision includes all lipid lowering medicinal products with marketing authorisations in Denmark on 15 March 2007.

Danish Medicines Agency

18-12-2018


Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Orphan designation: Mercaptopurine (oral suspension), Treatment of acute lymphoblastic leukaemia, 30/04/2009, Positive

Europe - EMA - European Medicines Agency

5-12-2018


Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Orphan designation: Paclitaxel (micellar), Treatment of ovarian cancer, 17/12/2006, Positive

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

18-4-2018

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (SOTIO a.s)

EU/3/18/2009 (Active substance: Autologous dendritic cells pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo) - Orphan designation - Commission Decision (2018)2405 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/246/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (StolmAr and Partner PatentanwAlte PartG mbB)

EU/3/18/2008 (Active substance: Adeno-associated viral vector serotype 9 encoding miRNA against human superoxide dismutase 1) - Orphan designation - Commission Decision (2018)2404 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/254/17

Europe -DG Health and Food Safety

18-4-2018

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Dr Philippe Moullier)

EU/3/18/2007 (Active substance: Adeno-associated viral vector serotype 8 containing the human acid alpha-glucosidase gene) - Orphan designation - Commission Decision (2018)2403 of Wed, 18 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/255/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (IQVIA RDS Ireland Limited)

EU/3/18/2005 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1893 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/222/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (IQVIA RDS Ireland Limited)

EU/3/18/2004 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1892 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/217/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Pharmadev Healthcare Ltd)

EU/3/18/2003 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1891 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/225/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Pharmadev Healthcare Ltd)

EU/3/18/2002 (Active substance: Ribavirin) - Orphan designation - Commission Decision (2018)1890 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/224/17

Europe -DG Health and Food Safety

23-3-2018

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (IQVIA RDS Ireland Limited)

EU/3/18/2006 (Active substance: Tazemetostat) - Orphan designation - Commission Decision (2018)1894 of Fri, 23 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/234/17

Europe -DG Health and Food Safety