BROMICIDE

Main information

  • Trade name:
  • NUFARM BROMICIDE 200 SELECTIVE HERBICIDE
  • Pharmaceutical form:
  • Emulsifiable
  • Units in package:
  • 5L, 20L, 110L, 200L, 1000L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical

Documents

Localization

  • Available in:
  • NUFARM BROMICIDE 200 SELECTIVE HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BARLEY | BARLEY - UNDERSOWN WITH CLOVER, LUCERNE | BARLEY - UNDERSOWN(CLOVER,LUCERNE,MEDIC) | BENT LAWN OR TURF | BUFFALO GRASS
  • Therapeutic area:
  • Group C Herbicide
  • Therapeutic indications:
  • AFRICAN DAISY | AMSINCKIA,YELLOW BURRWEED OR BURR GRASS | ANODA WEED | BELLVINE | BIFORA, CARROT WEED OR BIRD'S EYE | BINDY-EYE | BITOU BUSH OR BONESEED | BLACK BINDWEED | BLADDER KETMIA | CAPEWEED | CHAMOMILE OR MATRICARIA | CHARLOCK | CLEAVERS | CLIMBING BUCKWHEAT | COMMON MORNING GLORY | COMMON PEPPERCRESS | CORN GROMWELL, IRONWEED OR SHEEPWEED | COWVINE | CUDWEED | DWARF AMARANTH OR BOGGABRI WEED | FAT HEN | FIELD MADDER | FIERCE THORNAPPLE | FIREWEED | FUMITORY | GROUND OR ANNUAL GROUND CHERRY | HEDGE OR WILD MUSTARD | HORNED POPPY | INDIAN HEDGE MUSTARD | JO-JO | LESSER SWINECRESS OR BITTERCRESS | MELILOTUS OR HEXHAM SCENT | MEXICAN OR PRICKLY POPPY | MINTWEED | MOUNTAIN SORREL | MOUNTAIN SORREL/PURPLE CALANDRINIA | NOOGOORA BURR | PATERSON'S CURSE | PEACH VINE | PHEASANT'S-EYE OR ADONIS | ROUGH POPPY | SAFFRON THISTLE | SHEPHERD'S PURSE | SLENDER, SHORE OR SHEEP THISTLE | SOW OR MILK THISTLE | THREE CORNERED JACK OR DOUBLEGEE | THREE-HORNED BEDSTRAW | TREE HOGWEED | TURNIP WEED | VARIEGATED THISTLE | V
  • Product summary:
  • For the control of weeds in wheat, oats, barley, cereal rye and triticale (alone or undersown), grain sorghum, linseed, clover and lucerne pastures, turf, fallow, non-crop, roadsides and rights-of-way.Apply only to triticale cultivar Tyalla in Vic. See label re Pasture restrictions & Cereals undersown with legumes (2,4-D/MCPA mixtures).

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 31614/0909
  • Authorization date:
  • 25-11-2009
  • Last update:
  • 15-06-2017

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

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

POISON

ACTIVE CONSTITUENT: 200g/L BROMOXYNIL

present as the n-octanoyl ester.

SOLVENT: 616g/L LIQUID HYDROCARBON

For the control of weeds in wheat, oats, barley, cereal rye and triticale

(alone or undersown), grain sorghum, linseed, clover and lucerne pastures, turf,

fallow, non-crop, roadsides and rights-of-way as per the Directions For Use table.

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE USE.

Contents:

5 Litres

APVMA Approval No.: 31614/5L/0909

GROUP

HERBICIDE

C

ACN 004 377 780

Nufarm Australia Limited

Tel (03) 9282 1000 Fax (03) 9282 1001

103-105 Pipe Road, Laverton North, Vic.

JOB NO. 022379 | ID. NUFA_Bromicide 5L Label | COLOUR. Black, PMS 348, PMS 375

DIMENSIONS. 140mm(w)x140mm(h), PDF @ 100% on A4 | DESIGNER. Khoa Tran

31614_41972_5L_primary_MPL_V01.pdf

10/9/09 10:31 AM Page 1

APPROVED

LABEL

Info

pest

Verified

GENERAL INSTRUCTIONS:

Before opening, carefully read Directions For Use,

Precautionary and Protection Statements, Storage and

Disposal, Safety Directions, and First Aid Instructions.

Use only at recommended growth stages of crops and

weeds. DO NOT use on crops other than recommended.

STORAGE AND DISPOSAL:

Store in the closed, original container in a cool, well-

ventilated area. DO NOT store for prolonged periods

in 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 500mm 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.

SAFETY DIRECTIONS:

Product is poisonous if inhaled or swallowed. May irritate

the eyes and skin. Avoid contact with eyes and skin. DO

NOT inhale spray mist. When preparing spray wear

elbow-length PVC gloves and face shield. 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 and face shield.

FIRST AID:

If poisoning occurs, contact a Doctor or Poisons

Information Centre (Phone Australia 13 11 26).

If swallowed, DO NOT induce vomiting. Give a

glass of water.

MATERIAL SAFETY DATA SHEET:

For further information refer to the Material Safety Data

Sheet (MSDS), which can be obtained from your supplier

or from the Nufarm website – www.nufarm.com.au

CONDITIONS OF SALE:

“Any provisions or rights under the Trade Practices

Act 1974 or relevant state legislation which cannot be

excluded by those statutes or by law are not intended

to be excluded by these conditions of sale. Subject to

the foregoing, all warranties, conditions, rights and

remedies, expressed or implied under common law,

statute or otherwise, in relation to the sale, supply, use

or application of this product, are excluded. Nufarm

Australia Limited and/or its affiliates (“Nufarm”) shall not

accept any liability whatsoever (including consequential

loss), or howsoever arising (including negligence) for any

damage, injury or death connected with the sale, supply,

use or application of this product except for liability which

cannot be excluded by statute.”

In case of emergency: Phone 1800 033 498.

Ask for shift supervisor. Toll free 24 hours.

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road, Laverton North, Victoria 3026.

Tel: (03) 9282 1000 Fax: (03) 9282 1001

® Bromicide is a registered Trademark

of Nufarm Australia Limited.

OD022379

022379_NUFA_Bromicide 5L Label.qxd 10/9/09 10:31 AM Page 2

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

GENERAL INSTRUCTIONS:

Before opening, carefully read the Directions for Use, Precautionary

and Protection Statements, Storage and Disposal, Safety Directions

and First Aid Instructions. Use only at recommended growth stages

of crops and weeds. DO NOT use on crops other than recommended.

STORAGE AND DISPOSAL:

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

DO NOT store for prolonged periods in 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 500mm 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.

SAFETY DIRECTIONS:

Product is poisonous if inhaled or swallowed. May irritate the eyes

and skin. Avoid contact with eyes and skin. DO NOT inhale spray

mist. When preparing spray wear elbow-length PVC gloves and face

shield. After use and before eating, drinking or smoking, wash hands,

arms and face thoroughly with soap and water. After each days use,

wash gloves and face shield.

FIRST AID:

If poisoning occurs, contact a Doctor or Poisons Information Centre

(Phone Australia 13 11 26). If swallowed, DO NOT induce vomiting.

Give a glass of water.

MATERIAL SAFETY DATA SHEET:

For further information refer to the Material Safety Data Sheet (MSDS),

which can be obtained from your supplier or from the Nufarm website –

www.nufarm.com.au

CONDITIONS OF SALE:

“Any provisions or rights under the Trade Practices Act 1974 or

relevant state legislation which cannot be excluded by those statutes

or by law are not intended to be excluded by these conditions of sale.

Subject to the foregoing, all warranties, conditions, rights and

remedies, expressed or implied under common law, statute or

otherwise, in relation to the sale, supply, use or application of this

product, are excluded. Nufarm Australia Limited and/or its affiliates

(“Nufarm”) shall not accept any liability whatsoever (including

consequential loss), or howsoever arising (including negligence)

for any damage, injury or death connected with the sale, supply,

use or application of this product except for liability which cannot

be excluded by statute.”

In case of emergency: Phone 1800 033 498.

Ask for shift supervisor. Toll free 24 hours.

® Bromicide is a registered Trademark of Nufarm Australia Limited.

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Telephone: (03) 9282 1000

Facsimile: (03) 9282 1001

OD022379

ACTIVE CONSTITUENT: 200g/L BROMOXYNIL

present as the n-octanoyl ester

SOLVENT: 616g/L LIQUID HYDROCARBON

For the control of weeds in wheat, oats, barley,

cereal rye and triticale (alone or undersown),

grain sorghum, linseed, clover and lucerne

pastures, turf, fallow, non-crop, roadsides

and rights-of-way as per the

Directions For Use table.

IMPORTANT: READ THE ATTACHED

LEAFLET BEFORE USE

Contents:

20 Litres

APVMA Approval No.: 31614/20L/0909

GROUP

HERBICIDE

C

JOB NO. 022379 | ID. NUFA_Bromicide 20L Label | DIMENSIONS. 894mm(w)x366mm(h), PDF @ 40% on A3 | COLOUR. Black, PMS 348, PMS 375 | DESIGNER. Khoa Tran

31614_41972_20L_primary_MPL_V01.pdf

10/9/09 10:37 AM Page 1

APPROVED

LABEL

GENERAL INSTRUCTIONS

Before opening, carefully read Directions for Use, Precautionary and Protection Statements, Storage and Disposal, Safety Directions

and First Aid Instructions. Use only at recommended growth stages of crops and weeds. DO NOT use on crops other than recommended.

STORAGE AND DISPOSAL

Store the original sealed Envirodrum in a cool, well ventilated area.

DO NOT

store for prolonged periods in direct sunlight.

DO NOT

tamper with the Micro Matic valve or the security seal.

DO NOT

contaminate the Envirodrum with water or any other foreign matter.

After each use of the product, please ensure that the Micro Matic coupler, delivery system and hoses are disconnected, triple rinsed with

clean water and drained accordingly. When the contents of the Envirodrum have been used, please return the empty Envirodrum to the

point of purchase. The Envirodrum remains the property of Nufarm Australia Limited.

SAFETY DIRECTIONS

Product is poisonous if inhaled or swallowed. May irritate the eyes and skin. Avoid contact with eyes and skin. DO NOT inhale spray

mist. When preparing spray wear elbow-length PVC gloves and face-shield. 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 and face shield.

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information Centre (Phone Australia 13 11 26). If swallowed DO NOT induce vomiting.

Give a glass of water.

MATERIAL SAFETY DATA SHEET

For further information refer to the Material Safety Data Sheet (MSDS), which can be obtained from your supplier or from the Nufarm

website – www.nufarm.com.au

CONDITIONS OF SALE

“Any provisions or rights under the Trade Practices Act 1974 or relevant state legislation which cannot be excluded by those statutes

or by law are not intended to be excluded by these conditions of sale. Subject to the foregoing, all warranties, conditions, rights and

remedies, expressed or implied under common law, statute or otherwise, in relation to the sale, supply, use or application of this

product, are excluded. Nufarm Australia Limited and/or its affiliates (“Nufarm”) shall not accept any liability whatsoever (including

consequential loss), or howsoever arising (including negligence) for any damage, injury or death connected with the sale, supply,

use or application of this product except for liability which cannot be excluded by statute.”

In case of emergency: Phone 1800 033 498.

Ask for shift supervisor. Toll free 24 hours.

Batch No:

Date of Manufacture:

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road, Laverton North, Victoria 3026

Tel: (03) 9282 1000 Fax: (03) 9282 1001

® Bromicide is a registered Trademark of Nufarm Australia Limited.

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

POISON

ACTIVE CONSTITUENT: 200g/L BROMOXYNIL present as the n-octanoyl ester.

SOLVENT: 616g/L LIQUID HYDROCARBON

For the control of weeds in wheat, oats, barley, cereal rye and triticale (alone or undersown), grain sorghum, linseed,

clover and lucerne pastures, turf, fallow, non-crop, roadsides and rights-of-way as per the Directions For Use table.

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE USE.

Contents:

110

Litres

APVMA Approval No.: 31614/110L/0909

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road, Laverton North, Vic. Tel (03) 9282 1000 Fax (03) 9282 1001

GROUP

HERBICIDE

C

OD022379

JOB NO. 022379 | ID. NUFA_Bromicide 110L Label | DIMENSIONS. 420mm(w)x400mm(h), PDF @ 65% on A3 | COLOUR. Black, PMS 348, PMS 375 | DESIGNER. Khoa Tran

31614_41972_110L_primary_MPL_v01.pdf

10/9/09 10:38 AM Page 1

APPROVED

LABEL

GENERAL INSTRUCTIONS:

Before opening, carefully read Directions For

Use, Precautionary and Protection Statements,

Storage and Disposal, Safety Directions, and

First Aid Instructions. Use only at recommended

growth stages of crops and weeds. DO NOT

use on crops other than recommended.

STORAGE AND DISPOSAL:

Store in the closed, original container in a cool,

well-ventilated area. DO NOT store for prolonged

periods in 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

500mm 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.

SAFETY DIRECTIONS:

Product is poisonous if inhaled or swallowed.

May irritate the eyes and skin. Avoid contact

with eyes and skin. DO NOT inhale spray mist.

When preparing spray wear elbow-length PVC

gloves and face shield. After use and before

eating, drinking or smoking, wash hands, arms

and face thoroughly with soap and water. After

each days use, wash gloves and face shield.

FIRST AID:

If poisoning occurs, contact a Doctor or Poisons

Information Centre (Phone Australia 13 11 26).

If swallowed, DO NOT induce vomiting. Give a

glass of water.

MATERIAL SAFETY DATA SHEET:

For further information refer to the Material

Safety Data Sheet (MSDS), which can be

obtained from your supplier or from the

Nufarm website – www.nufarm.com.au

CONDITIONS OF SALE:

“Any provisions or rights under the Trade

Practices Act 1974 or relevant state legislation

which cannot be excluded by those statutes or

by law are not intended to be excluded by these

conditions of sale. Subject to the foregoing, all

warranties, conditions, rights and remedies,

expressed or implied under common law,

statute or otherwise, in relation to the sale,

supply, use or application of this product, are

excluded. Nufarm Australia Limited and/or its

affiliates (“Nufarm”) shall not accept any liability

whatsoever (including consequential loss), or

howsoever arising (including negligence) for

any damage, injury or death connected with

the sale, supply, use or application of this

product except for liability which cannot be

excluded by statute.”

In case of emergency: Phone 1800 033 498.

Ask for shift supervisor. Toll free 24 hours.

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road,

Laverton North,

Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

® Bromicide is a registered

Trademark of Nufarm

Australia Limited.

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

POISON

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road, Laverton North, Vic. Tel (03) 9282 1000 Fax (03) 9282 1001

OD022379

ACTIVE CONSTITUENT: 200g/L BROMOXYNIL

present as the n-octanoyl ester.

SOLVENT: 616g/L LIQUID HYDROCARBON

For the control of weeds in wheat, oats, barley, cereal rye and triticale

(alone or undersown), grain sorghum, linseed, clover and lucerne pastures, turf,

fallow, non-crop, roadsides and rights-of-way as per the Directions For Use table.

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE USE.

Contents:

200

Litres

APVMA Approval No.: 31614/200L/0909

GROUP

HERBICIDE

C

JOB NO. 022379 | ID. NUFA_Bromicide 200L Label | DIMENSIONS. 495mm(w)x217mm(h), PDF @ 80% on A3 | COLOUR. Black, PMS 348, PMS 375 | DESIGNER. Khoa Tran

31614_41972_200L_primary_MPL_V01.pdf

10/9/09 10:39 AM Page 1

APPROVED

LABEL

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

POISON

ACTIVE CONSTITUENT: 200g/L BROMOXYNIL

present as the n-octanoyl ester.

SOLVENT: 616g/L LIQUID HYDROCARBON

For the control of weeds in wheat, oats, barley, cereal rye and triticale

(alone or undersown), grain sorghum, linseed, clover and lucerne pastures, turf,

fallow, non-crop, roadsides and rights-of-way as per the Directions For Use table.

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE USE.

Contents:

1000

Litres

APVMA Approval No.: 31614/1000L/0909

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road, Laverton North, Vic. Tel (03) 9282 1000 Fax (03) 9282 1001

GROUP

HERBICIDE

C

GENERAL INSTRUCTIONS

Before opening, carefully read Directions for Use,

Precautionary and Protection Statements, Storage

and Disposal, Safety Directions and First Aid

Instructions. Use only at recommended growth

stages of crops and weeds. DO NOT use on crops

other than recommended.

STORAGE AND DISPOSAL

Store in the closed,original container in a cool,

well-ventilated area. DO NOT store for prolonged

periods in direct sunlight. Empty contents fully into

application equipment. Close all valves and return

to point of supply for refill or storage.

SAFETY DIRECTIONS

Product is poisonous if inhaled or swallowed. May

irritate the eyes and skin. Avoid contact with eyes

and skin. DO NOT inhale spray mist. When

preparing spray wear elbow-length PVC gloves

and face-shield. 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 and face shield.

FIRST AID

If poisoning occurs, contact a doctor or Poisons

Information Centre (Phone Australia 13 11 26).

If swallowed DO NOT induce vomiting. Give a

glass of water.

MATERIAL SAFETY DATA SHEET

For further information refer to the Material Safety

Data Sheet (MSDS), which can be obtained from

your supplier or from the Nufarm website –

www.nufarm.com.au

CONDITIONS OF SALE

“Any provisions or rights under the Trade Practices

Act 1974 or relevant state legislation which cannot

be excluded by those statutes or by law are not

intended to be excluded by these conditions of

sale. Subject to the foregoing, all warranties,

conditions, rights and remedies, expressed or

implied under common law, statute or otherwise,

in relation to the sale, supply, use or application

of this product, are excluded. Nufarm Australia

Limited and/or its affiliates (“Nufarm”) shall not

accept any liability whatsoever (including

consequential loss), or howsoever arising

(including negligence) for any damage, injury

or death connected with the sale, supply, use

or application of this product except for liability

which cannot be excluded by statute.”

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

Batch No:

Date of Manufacture:

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road,

Laverton North,

Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

® Bromicide is a

registered Trademark

of Nufarm Australia Limited.

OD022379

JOB NO. 022379 | ID. NUFA_Bromicide 1000L Label | DIMENSIONS. 190mm(w)x390mm(h), PDF @ 65% on A3

COLOUR. Black, PMS 348, PMS 375 | DESIGNER. Khoa Tran

31614_41972_1000L_MPL_V01.pdf

10/9/09 10:45 AM Page 1

APPROVED

LABEL

Nufarm

Bromicide

®

200

Selective Herbicide

ACTIVE CONSTITUENT: 200 g/L BROMOXYNIL

present as the n-octanoyl ester

SOLVENT: 616 g/L LIQUID HYDROCARBON

For the control of weeds in wheat, oats, barley, cereal rye and

triticale (alone or undersown), grain sorghum, linseed, clover

and lucerne pastures, turf, fallow, non-crop, roadsides and

rights-of-way as per the Directions For Use table.

READ THOROUGHLY BEFORE USING.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET PLANTS

Drift Warning: DO NOT apply under weather conditions, or from spraying equipment, that may cause

ay to drift onto nearby susceptible plants/crops, cropping lands or pastures.

Note: Maximum daily temperatures at or above 20°C at application, or on days following treatment

y result in seedling mortality and established plants may be damaged.

PRO

TECTION OF LIVESTOCK

Low hazard to bees. May be applied at any time as recommended in the Directions for Use.

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

(5L, 20L and 200L onl

y)

Store in the closed, original container in a cool, well-ventilated area. Do not store for prolonged

iods in direct sunlight. Triple or prefer

ably 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.

Refillable containers (1000L only)

Store in the closed,original container in a cool, well-ventilated area. Do not store for prolonged periods

in direct sunlight.

Empty contents fully into application equipment. Close all valves and return to point

of supply for refill or storage.

Envirodrum 110 L Mini Bulk Returnable Container

Store the original sealed En

virodrum in a cool, well ventilated area. Do not store f

or prolonged periods

in direct sunlight. Do not tamper with the Micro Matic valve or the security seal. Do not contaminate

the Envirodrum with water or any other foreign matter.

After each use of the product, please ensure that the Micro Matic coupler, delivery system and hoses

are disconnected, triple rinsed with clean water and drained accordingly. When the contents of the

Envirodrum have been used, please return the empty Envirodrum to the point of purchase. The

Envirodrum remains the property of Nufarm Australia Limited.

SAFETY DIRECTIONS

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

and skin.

Do not inhale spray mist. When preparing spray wear elbow-length PVC gloves and

face-shield. 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 and face shield.

FIRST AID

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

swallowed, do NOT induce vomiting.

Give a glass of water.

MATERIAL SAFETY DATA SHEET

For further information refer to the Material Safety Data Sheet (MSDS), which can be obtained

from your supplier or from the Nufarm website - www.nufarm.com.au

CONDITIONS OF SALE

“An

y provisions or rights under the Trade Practices Act 1974 or rele

vant state legislation which cannot

be excluded by those statutes or by law are not intended to be excluded by these conditions of sale.

Subject to the foregoing, all warranties, conditions, rights and remedies, expressed or implied under

common law, statute or otherwise, in relation to the sale, supply, use or application of this product, are

excluded.

Nufarm Australia Limited and/or its affiliates (“Nufarm”) shall not accept any liability whatsoever

(including consequential loss), or howsoever arising (including negligence) for any damage, injury or

death connected with the sale, supply, use or application of this product except for liability which

cannot be excluded by statute.”

APVMA Approval No. 31614/0909

In case of emergency: Phone 1800 033 498

Ask for shift super

visor. Toll free 24 hours.

Bromicide, Nugrass, Amicide, Associate, Credit, Bonus, Weedmaster, Comet, Agritone and

Kamba are registered trademarks of Nufarm Australia Limited.

Paragon is a registered trademark of BASF.

Registered trademark of Monsanto Technology LLC used under licence by Nufarm Australia

Limited.

Other registered trademarks.

Nufarm Australia Limited

ACN 004 377 780

APVMA Approval No: 31614/0909

103-105 Pipe Road

Laverton North Vic. 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

GENERAL INSTRUCTIONS

Before opening, carefully read Directions for Use, Precautionary and Protection Statements, Storage

and Disposal, Safety Directions and First Aid Instructions. Use only at recommended growth stages of

crops and weeds. Do not use on crops other than recommended.

MIXING INFORMATION

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

product.

Agitate thoroughly, then add the remainder of water. Agitate again bef

ore spraying

commences.

BOOM SPRAYER

USE ONLY low boom equipment set up to provide good coverage of weeds within the crop canopy.

USE ONLY coarse spray quality according to ASAE S572 definition f

or standard nozzles.

Apply 50-200 litres (WA: 50 to 100 litres) of water per hectare

. 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. 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.

AERIAL APPLICATION

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

passes o

verhead. Application by micronaire equipment may giv

e variable results.

EQUIPMENT MAINTENANCE

After use, wash equipment thoroughly and rinse several times prior to re-use. Wash sprayer

thoroughly with clean water after use. If using tank mixes with Amicide 625 or MCPA 500 apply with

equipment that will not be used in 2,4-D and MCP

A susceptible crops, particularly cotton and vines.

COMPATIBILITY

This product may be mixed in the spray tank with one of the following herbicides or insecticides in

wheat and bar

ley only.

Nufarm Nugrass

, Omethoate, Chlorpyrifos, dimethoate, endosulfan, Nufarm Amicide

625 Herbicide

(2,4-D Amine), Nufarm MCPA 500 Herbicide, Agritone

750, Glean*/Lusta™, Ally*/Associate

Brodal*, Glyphosate products (Nufarm Glyphosate CT, Credit

/Bonus

, Weedmaster

Duo and

Weedmaster

490 CT Plus, Roundup^, Roundup^ CT, Roundup^ PowerMax) Nufarm Kamba

500,

Paragon

. Bromicide 200 is compatible with Comet

200 / Sterane* 200 when needed for control of

mixed weed populations in grain sorghum. As formulations of other manufacturers products are

beyond the control of Nufarm, all mixtures should be tested prior to mixing commercial quantities.

RESISTANT WEEDS WARNING

Bromicide 200 Selective Herbicide (Bromicide 200) is a member of the nitriles group of herbicides.

Bromicide 200 has the inhibitors of photosynthesis at photosystem II mode of action.

For weed

resistance management Bromicide 200 is a Group C herbicide.

Some natur

ally-occurring weed biotypes resistant to Bromicide 200 and other Group C 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 this product or other Group C herbicides.

Since the occurrence of resistant weeds is difficult to detect prior to use, Nufarm Australia Limited

accepts no liability for any losses that may result from the failure of Bromicide 200 to control resistant

weeds.

PRECAUTION

RE-ENTRY PERIOD

Do not allow entry into treated areas until the spray has dried, unless wearing cotton overalls buttoned

to the nec

k and wrist (or equivalent clothing) and chemical resistant gloves

. Clothing must be

laundered after each day’s use.

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

DIRECTIONS FOR USE Continued

Situation & Crop

Weeds Controlled

State

Rate

Critical Comments

Turf: Established

Couch (including

Queensland Blue),

Buff

alo, Bent,

Paspalum, Kikuyu,

Fescue, and Rye lawns

Bindy-eye (Calotis hispidula)

Jo-jo (Onehunga)

(Soliva pterosper

Cudweed

(Gnaphalium spp.)

All States

6.0L/

500L

water

per ha

High

Volume:

300mL

per 100L

60mL/

100m

per 15L

knapsack

Apply evenly over the area to be treated. A slight browning of grasses, especially Paspalum,

may occur in hot conditions.

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

LEGISLATION.

WITHHOLDING PERIOD

CROP HARVEST: NOT REQUIRED WHEN USED AS DIRECTED.

GRAZING/STOCKFOOD: DO NOT GRAZE TREATED CROPS OR CUT FOR STOCK FOOD FOR 8 WEEKS AFTER APPLICATION.

GROUP HERBICIDE

C

Situation & Crop

Weeds Controlled

Weed Stage

State

Rate

Critical Comments

Fallow & Non Crop

Pastures

Pastures, Roadsides

and Rights-of-Way

Cowvine or Peachvine (Ipomoea lonchophylla)

Climbing buckwheat (Fallopia convolvulus)

Volunteer conventional cotton

(Gossypium hirsutum)

Volunteer Roundup Ready

cotton

(Gossypium hirsutum)

Adonis (Pheasants Eye)

Birds Eye (Carrot Weed)

Double Gee

, Wild Radish

Matricaria

Fireweed

African Daisy (Senecio pterophorus)

Boneseed/Bitou-bush

(Chrysanthemoides monilifera)

Up to 6 leaves

Up to 8 leaves

Cotyledon to

mature, vining

plants

Cotyledon to 6

leaves

Cotyledon to 6

leaves

Up to 4 leaves

More than 4

leaves

Up to 4 leaves

Up to 3 leaves

Seedlings

Early flowering

Up to and

including the

flowering stage

Seedlings only

Qld, NSW,

ACT only

Qld, NSW,

WA, NT only

SA only

WA only

Qld, NSW,

ACT only

SA only

Vic, Tas only

1.4 L to

2.1 L/ha

1.5 L/ha

alone or 1 -

1.5 L/ha plus

glyphosate

1.5 L/ha

alone or 1 -

1.5 L/ha plus

glyphosate

1.5 L/ha

alone or plus

glyphosate

700 mL

1.4 L

1.5 L

750 mL

1.4 L

2.8 L

300mL per

100L water

160mL per

100L water

For all fallow and non crop situations

Complete coverage is essential, plants which are shaded by stubble or other weeds will not

be controlled. Weeds that are drought stressed and sprayed under hot conditions may not

be adequately controlled. The addition of glyphosate will provide broader spectrum weed

control where needed. Refer to the Compatibility section for appropriate glyphosate

products. The rate of glyphosate used should be robust for the conditions and sufficient to

control the hardest-to-kill weed in the situation.

For general fallow weed control application volumes above 50 L/ha are recommended.

For volunteer cotton control, including Roundup Ready varieties a minimum spray volume of

80 L/ha should be used. Bromicide 200 alone or with glyphosate will not provide

satisfactory

control of ratoon or “stub” cotton.

Apply in May-June. Medics may be severely scorched at the low rate and killed at the high

rate. Do not apply to polymorpha medics.

Avoid application to clover-based pastures in temperatures over 20ºC or when temperatures

above 20ºC may follow for some days after application; as seedling mortality may occur and

established plants may be damaged.

Apply with low volume boom spray during autumn/winter, when weeds are young and

actively growing. Not effective on mature plants.

The plants, including the stems, must be thoroughly wet to the point of run-off. Apply when

the plants are actively growing. Spraymate Activator should be added at 125mL per 100

litres of spray. A follow-up treatment may be necessary for large, well-established plants.

Ensure an overall spray coverage on weed seedlings.

31614_41972_leaflet_MPL_V01.pdf

2/9/09 8:49 AM Page 1

Dimensions: 368mm (w) x 242mm (h); PDF @ 100% on A3 size

Situation & Crop

Weeds Controlled

Weed Stage

State

Rate

Critical Comments

DIRECTIONS FOR USE

RESTRAINTS

DO NOT apply by mister machines.

DO NOT apply if crops or weeds are stressed due to excessively dry or moist conditions.

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

DO NOT apply when rain is expected within 3 hours.

DO NOT apply to lucerne crops or clover based pastures or turf in temperatures above 20˚C or when temperatures above 20˚C may follow for some days after application.

DO NOT apply when windspeed is less than 3 or more than 20km per hour at application site.

DO NOT apply during surface temperature inversion conditions at the application site.

DO NOT apply with smaller than COARSE spray quality according to ASAE S572 definition for standard nozzles.

Wheat, Barley, Cereal

Rye, Oats and

Triticale: including

those underso

wn with

Clover, Lucerne or

Medic (Vic only);

Linseed;

Clover or

Lucerne P

astures;

Lotus seed or forage

cr

ops (Qld only)

Wheat, Barley,

Cereal

Rye, Oats and

Triticale: including

those underso

wn with

Clov

er, Lucerne or

Medics;

Clo

ver Seed Crops

Amsinckia (Amsinckia spp.), Black Bindweed

(Climbing buckwheat) (Fallopia convolvulus),

Capeweed, (Arctotheca calendula),

Chamomile (Matricar

ia matricarioides),

Common Peppercress (Lepidium africanum),

Corn Gromwell (Ironweed, Sheepweed)

(Buglossoides arvensis),

Fat Hen (Chenopodium album),

Field Madder (Sherardia arvensis),

Lesser Swinecress (Coronopus didymus),

Mountain sorrel (Oxalis acetosella),

Purple Calandrinia (Calandrinia menziesii),

Saffron Thistle (Carthamus lanatus),

Shepherd’s Purse (Capsella bursa-pastoris),

Three-horned bedstraw (Gallium tricornutum)

Tree Hogweed (Polygonum patulum),

Variegated Thistle (Silybum marianum),

Mexican P

oppy (Argemone ochroleuca),

Threecornered Jack (Doub

legee, Spiny Emex)

(Emex australis), Turnip Weed (Giant Mustard)

(Rapistrum rugosum),

Wild Radish (Raphanus raphanistrum),

Wild Mustard (Sisymbrium spp.),

Wild Turnip (Brassica tournefor

tii),

Wireweed

(Polygonum aviculare),

Paterson’s Curse

(Echium plantagineum)

(Salvation Jane)

Fumitories

(Fumaria spp.)

Pheasant’s Eye (Adonis microcarpa),

Birds Eye (Carrot Weed) (Cotula australis)

Fireweed (Senecio spp.)

Amsinckia (Amsinckia spp.),

Capeweed (Arctotheca calendula),

Chamomile (Matricaria matricarioides),

Charlock (Sinapis arvenses),

Corn Gromw

ell (Ironweed, Sheepweed)

(Buglossoides arvensis),

Fat Hen (Chenopodium alb

um),

Field Madder (Sherardia arvensis),

Hexham Scent (King Island Melilot)

(Melilotus indicus) ,

ned Poppy (Glaucium flavum),

Indian Hedge Mustard (Sisymbr

ium orientale),

Lesser Swinecress (Coronopus didymus),

Mexican Poppy (Argemone ochroleuca),

Mintweed (Salvia reflexa),

Purple Calandrinia (Calandrinia menziesii),

Paterson’s Curse

(Salvation Jane)

(Echium plantagineum),

Rough Poppy

(Papaver h

ybridum),

Saffron Thistle (Carthamus lanatus),

Shepherd’s Purse (Capsella b

ursa-pastoris),

Slender Thistle (Carduus tenuiflorus),

Turnip Weed (Giant Mustard)

(Rapistrum rugosum),

Wild Radish (Raphanus raphanistrum),

Common Peppercress (Lepidium africanum),

Tree Hogweed (Polygonum patulum),

Black Bindweed (Climbing Buckwheat)

(Fallopia convolvulus),

Up to the 4 leaf

stage or when

plants are no

more than 35mm

in diameter

Up to the 6 leaf

stage or when

plants are no

more than 50mm

in diameter

Up to the 4 leaf

stage or when

plants are no

more than 50mm

in diameter

Up to the 4 true

leaf stage

Greater than the

4 true leaf stage

Seedlings

Early flowering

stage

Up to the 5 leaf

stage or when

plants are no

more than 50mm

in diameter

Up to the 8 leaf

stage.

All States

Qld, NSW,

Vic, SA, WA,

ACT only

SA only

Qld, NSW,

ACT only

WA only

Vic, SA only

Vic only

Vic, SA only

1.4L/ha

2.0L/ha

700mL/ha

1.4L/ha

1.4L/ha

2.8L/ha

750mL/ha

PLUS

440mL

Nufarm

Amicide 625

/ha OR

PLUS

700mL of

Nufarm

MCPA 500

1.4L/ha

PLUS

440mL

Nufarm

Amicide 625

/ha OR

PLUS

700mL of

Nufarm

MCPA 500

CROP STAGE:

Wheat, Barley, Cereal, Rye, Oats and Triticale: 3 leaf to full tillered (Zadoks Scale Z13-Z 30).

Linseed: 50 to 150mm high.

Lucerne and Clover: After seedlings have one trifoliate leaf or before there is 150mm

regrowth in established stands.

Lotus: Apply post-emergence at least 4 w

eeks after sowing (crop seedlings with a

minim

um of 2-6 true leaves).

APPLICATION: Ref

er to General Instructions. Avoid application when maximum daily

temperatures above 20°C occur, or are likely to occur for a few days after application. Good

coverage of the spray on the weed is essential. Apply only in the Autumn and Winter

(mid-April to end of August). For optimum control, apply only when the weeds are actively

growing and before the weeds are shielded by the crop.

CAUTION:

Lucerne and Clover: This product will cause slight leaf burning of undersown lucerne and

ver. DO NO

T apply to Persian clover or Berseem clover.

Linseed: DO NOT spray linseed by aerial application.

Lotus: Some initial scorching of leav

es may occur in some cases.

Medics: Application to some cultivars of Medics may result in unacceptable crop damage in

some situations.

# Effective control of Paterson’

s Curse and Fumitories will only be obtained under good

growing conditions.

## Where Wireweed is growing under stress, it has been found to be less susceptible.

DO NOT use where undersown medics occur.

Apply during the Autumn-Winter period when weeds are young and actively growing. Not

effective on mature plants.

CROP STAGE:

Cereals: 3 leaf to fully tillered. (Zadoks Scale Z13-30).

Clover: Apply after clover seedlings have at least three trifoliate leaves

APPLICATION: Refer to General Instructions. A

void application when maximum daily

temperatures above 20°C occur, or are likely to occur for a few days after application. Apply

only in the Autumn and Winter (mid-April to end of August). Apply only when weeds are

actively growing and before the weeds are shielded by the crop.

CAUTION:

Some crop damage and/or yield loss may occur in Olympic and Shortim wheat cultivars.

DO NO

T apply to Persian clover or Berseem clover. A slight burning of clover may occur.

DO NOT use 2,4-D or MCPA tank mix if wheat, oats, barley or triticale are undersown with

lucerne, clover or medics unless some damage is acceptable. This product may be tank

mixed with Hoegrass*/Nugrass

for control of Annual Rye Grass and Wild Oats in Wheat

and Barley only. DO NOT use 2,4-D or MCPA tank mix if using a tank mix with

Hoegrass*/Nugrass

Situation & Crop

Weeds Controlled

Weed Stage

State

Rate

Critical Comments

Wheat, Oats, Barley,

Triticale alone or with

undersown lucerne

and clover

Wheat, Barley, Oats

and Triticale

Grain sorghum

Common Sowthistle (Sonchus oleraceus)

Threecornered Jack (Doublegee, Spiny Emex)

(Emex australis),

Wireweed (Polygonum aviculare),

Variegated Thistle (Silybum marianum)

Fumitories (Fumaria spp.)

Wild Mustard (Sisymbrium spp.),

Wild Turnip (Brassica tournefortii)

Cleavers

Threecornered Jack (Doublegee, Spin

y Emex)

(Emex australis)

Wireweed (Polygonum aviculare)

Fumitories (Fumaria spp.)

Black Bindweed (Climbing Buckwheat)

(Fallopia convolvulus),

Chamomile (Matricar

ia matricarioides),

Fat Hen (Chenopodium album),

Field Madder (Sher

ardia arv

ensis),

Lesser Swinecress (Coronopus didymus),

Mountain sorrel (Oxalis acetosella),

Purple Calandrinia (Calandrinia menziesii),

Paterson’s Curse (Salvation J

ane)

(Echium plantagineum),

Shepherd’s Purse (Capsella bursa-pastoris),

Three-horned bedstraw (Gallium tricornutum),

Variegated Thistle (Silybum marianum)

Cowvine or Peachvine (Ipomoea lonchophylla),

Bellvine (l. plebeia)

Cowvine or Peachvine (Ipomoea lonchophylla)

Cowvine or Peachvine (Ipomoea lonchophylla),

Bellvine (l. plebeia),

Morning glory (l. purpurea),

Bladder Ketmia (Hibiscus trionum),

ual ground cherry (Physalis angulata),

Fierce thornapple (Datura ferox),

Anoda weed (Anoda cristata)

Up to 4 leaves

4 to 8 leaves

Up to the 4 leaf

stage or when

plants are no

more than 50mm

in diameter

2-4 stems +

1-3 whorls of

leaves/stem

4-5 leaf stage

5 to 8 leaf stage

Up to 4 leaves

4 to 8 leaves

Up to 4 leaves

4 to 8 leaves

Qld,

Northern

NSW only

Qld, NSW,

Tas, SA,

ACT only

Qld, NSW,

ACT, Vic only

Qld, Vic only

Qld, Vic,

NSW, ACT,

Tas only

WA only

Qld, Vic,

NSW, ACT,

SA, Tas only

Qld, NSW,

Vic, SA, ACT

only

All States

Qld, NSW

only

1.4 L/ha

2.1 L/ha

1.4L/ha

PLUS

440mL

Nufarm

Amicide 625

/ha OR

PLUS

700mL of

Nufarm

MCPA 500

2.1L/ha

PLUS

400mL

Nufarm

Amicide 625

/ha OR

PLUS

700mL of

Nufarm

MCPA 500

1.5 L/ha

2 L/ha

1.5 L/ha

PLUS

1.1 kg/ha

Nufarm

Nutrazine

900DF

2 L/ha PLUS

1.1 kg/ha

Nufarm

Nutrazine

900DF

APPLICATION: Refer to General Instructions. Avoid application when maximum daily

temperatures above 20°C occur, or are likely to occur for a few days after application. Good

coverage of the spray on the weed is essential. Apply only in the Autumn and Winter (mid-

April to end of August). For optimum

control, apply only when the weeds are actively growing

and before the weeds are shielded by the crop.

CAUTION:

Lucerne and Clover: This product will cause slight leaf burning of undersown lucerne and

Clover. DO NO

T apply to Persian clover or Berseem clover.

Strictly for use on small weeds early in crop before shading out.

CROP STAGE:

Wheat, Barley, Oats and Triticale: 3 leaf to mid tillering (Z13-Z23).

Use a minimum spray volume of 70 L/ha. If Group B

resistance is suspected, or weeds have

grown through

a previous application of chlorsulfuron apply 2.1 L/ha

CROP STAGE:

Wheat, Barley, Oats and

Triticale: 3 leaf to full tillering (Z13-Z30).

This product will cause slight leaf burning of undersown lucerne and clo

ver.

CROP STAGE:

5 leaf to fully tillered (Zadoks scale Z15-30): Apply under good growing conditions.

BOOM SPRAYING:

Use a minimum of 220L spray per hectare on Black Bindweed when crop is greater than

300mm high.

CAUTION:

Some crop damage and/or yield loss may occur in Olympic and Shortim wheat cultivars.

DO NO

T mix with 2,4-D or MCPA tank mix if wheat, oats, barle

y or triticale are undersown

with lucerne, clover or medics unless some damage is acceptable. DO NOT apply to

medics (WA only). This product may be tank mixed with Hoegrass*/Nugrass

for control of

Annual Rye Grass and Wild Oats in Wheat and Barley only. DO NOT use 2,4-D or MCPA

tank mix if using a tank mix with Hoegrass*/Nugrass

APPLICATION:

Refer to General Instructions. Avoid application when maximum daily temperatures above

20°C occur, or are likely to occur for a few days after application.

CROP STAGE:

4-12 leaf stage. This product may cause tr

ansient leaf burn of some sorghum varieties.

APPLICATION:

ond the 6-8 leaf stage of the crop, dropped nozzles should be used to minimize

chemical being sprayed into the whor

l and on upper leaves of the crop and to reduce

shading of weeds.

Use on small weeds early in the crop life to prevent shading out of the weeds. Spray when

weeds are actively growing and not when drought stressed.

Use a minimum spray volume of 70 L/ha.

CROP STAGE:

4-12 leaf stage. This product may cause transient leaf b

urn of some sorghum varieties

APPLICATION:

Beyond the 6-8 leaf stage of the crop, dropped nozzles should be used to minimize

chemical being spr

ayed into the whorl and on upper lea

ves of the crop and to reduce

shading of weeds.

Use on small weeds early in the crop life to prevent shading out of the weeds. Spray when

weeds are actively growing and not when drought stressed.

Use a minimum spray volume of 70 L/ha.

Add a non-ionic surfactant.

Do not use on sandy soils.

Bromicide 200 Leaflet 2/9/09 8:49 AM Page 2

Dimensions: 368mm (w) x 242mm (h); PDF @ 100% on A3 size

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Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

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

13-1-2019

Motorcrosser Jeffrey Herlings geridderd

Motorcrosser Jeffrey Herlings geridderd

Op het jaarlijkse gala van motorsportend Nederland kreeg Jeffrey Herlings een verrassende boodschap. Sportminister Bruno Bruins bracht de bijzondere melding dat de Koning hem heeft benoemd tot Ridder in de Orde van Oranje Nassau.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

12-1-2019

Biljartster Therese Klompenhouwer geridderd

Biljartster Therese Klompenhouwer geridderd

Op het Nederlands Kampioenschap driebanden tussen de wedstrijden door werd Therese Klompenhouwer verrast met een bijzondere boodschap. Minister Bruno Bruins (Sport) kon in Berlicum melden dat de Koning haar heeft benoemd tot Ridder in de Orde van Oranje Nassau.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

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

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

28-12-2018

The red palm weevil

The red palm weevil

What is the red palm weevil? The red palm weevil (Rhynchophorus ferrugineus) is a beetle that is a particular menace to palm trees. Originally from South and South-east Asia, it is now found in more than 60 countries, where it threatens date palms, ornamental palms and coconut palms. It has been present in France since 2006; it was first detected in the Provence-Alpes-Côte d'Azur region (French Riviera) and has now become established in the Occitanie region and Corsica.

France - Agence Nationale du Médicament Vétérinaire

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

Beeld wachttijden ggz verbeterd

Beeld wachttijden ggz verbeterd

Mensen die geestelijke gezondheidszorg nodig hebben, moeten vaak lang wachten op behandeling. Het blijkt niet eenvoudig alle wachttijden terug te brengen tot een acceptabel niveau, de zogenoemde Treeknormen*. Toch laten de nieuwste cijfers van de NZa een gunstiger beeld zien dan het beeld van afgelopen juli. Daaruit blijkt dat voor alle diagnosegroepen mensen te lang op een intake moeten wachten. Vervolgens kunnen mensen die basis-ggz nodig hebben, wel op tijd aan hun behandeling beginnen. Dat geldt ook ...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

21-12-2018

Peer review of the pesticide risk assessment of the active substance propanil

Peer review of the pesticide risk assessment of the active substance propanil

Published on: Thu, 20 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Italy for the pesticide active substance propanil and the assessment of applications for maximum residue levels (MRLs) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of t...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for mesotrione in light of confirmatory data

Published on: Wed, 19 Dec 2018 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

The red palm weevil:  combating the loss of palm trees on the Mediterranean coast

The red palm weevil: combating the loss of palm trees on the Mediterranean coast

The palm weevil is one of the most damaging insect pests of palm trees, and is a threat to plant biodiversity in many countries. This insect has spread rapidly along the Mediterranean coast in the last ten years or more, and is classified as a regulated quarantine pest and a major danger to plant health in France. It is therefore subject to compulsory control measures. In order to curb the spread of the pest, which was introduced into the country in 2006, control strategies are being implemented at local...

France - Agence Nationale du Médicament Vétérinaire

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

14-12-2018

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance bromoxynil in light of negligible exposure data submitted

Published on: Thu, 13 Dec 2018 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State France for the pesticide active substance bromoxynil are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to bromoxynil can be considered negligible, taking into account the European Commission's draft guidance on this topic. The conclusions w...

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

3-12-2018

Wielrenster Annemiek van Vleuten geridderd

Wielrenster Annemiek van Vleuten geridderd

Op het wielrengala in Den Bosch werd wielrenster Annemiek van Vleuten verrast met een bijzondere boodschap. Sportminister Bruno Bruins kon melden dat de Koning heeft besloten haar te benoemen tot Ridder in de Orde van Oranje Nassau. Onder luid applaus kreeg Van Vleuten de bijbehorende versierselen opgespeld door de minister.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Mariam, Floris en Mookie beëdigd tot kinderbewindspersonen van VWS

Nederland is vandaag op de Internationale Dag van de Rechten van het Kind drie bewindspersonen rijker. Mariam Yousfi (13 jaar) en Floris Vooren (13 jaar) zijn door ministers Hugo de Jonge en Bruno Bruins benoemd tot kinderminister en Mookie Saluna (15 jaar) is door staatssecretaris Paul Blokhuis benoemd tot kinderstaatssecretaris. De kinderbewindspersonen zullen een jaar lang het ministerie van Volksgezondheid, Welzijn en Sport (VWS) met slimme tips en praktische adviezen helpen het beleid beter en kindv...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of (EZ)‐1,3‐dichloropropene ...

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

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

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

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

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

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

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