ASULOX

Main information

  • Trade name:
  • ASULOX SELECTIVE HERBICIDE
  • Pharmaceutical form:
  • Aqueous
  • Units in package:
  • 1L, 5L, 10L, 20L, 110L
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • UPL AUSTRALIA

Documents

Localization

  • Available in:
  • ASULOX SELECTIVE HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • APPLE ORCHARD | CHEWING'S FESCUE | COCKSFOOT | HOPS | LUCERNE OVER 1 YEAR OLD | ONION | PASTURE | PERENNIAL RYEGRASS PASTURE | P
  • Therapeutic area:
  • Group R Herbicide
  • Therapeutic indications:
  • AWNLESS BARNYARD GRASS | BARNYARD GRASS OR WATER GRASS | BRACKEN | BROADLEAF DOCK | CROWSFOOT GRASS | CURLED DOCK | DOCK | FALSE BROME | FIDDLE DOCK | GREEN SUMMER GRASS | GUINEA GRASS - SEEDLING | HAIRY PANIC | ITCH GRASS | JOHNSON GRASS | MADRID OR LESSER BROME | PARA GRASS | PRAIRIE OR ANNUAL PRAIRIE GRASS | SHIVERY OR LESSER QUAKING GRASS | SILVER GRASS OR RAT'S-TAIL FESCUE | SILVERY HAIRGRASS | SOFT BROME - BROMUS HORDEACEUS | SORREL | SQUIRREL-TAIL FESCUE OR SILVER GRASS | STERILE BROME | SUBTERRANEAN CLOVER | SUMMER OR CRAB GRASS - D. CILIARIS | SUMMER OR CRAB GRASS - D. SANGUINALIS | VASEY GRASS | WINTER GRASS | YORKSHIRE FOG GRASS | ACETOSELLA VULGARIS | ANNUAL BLUE GRASS | ANNUAL POA | AUSTRAL BRACKEN | BRACHYPODIUM PINNATUM | BROADLEAF DOCK | BROME FESCUE | BROMUS CATHARTICUS | BROMUS STAMINEUS | BROMUS WILDENOWII | COMMON BRACKEN | COMPACT BROME | CRAB GRASS | CURLED DOCK | ENGLISH DOCK | FESTUCA BROMOIDES | FESTUCA MYUROS | FOG GRASS | GIANT PASPALUM | GOOSE GRASS | GREEN SUMMERGRASS | LESSER BRO
  • Product summary:
  • For control of bracken fern in pastures, grasses in sugarcane, and a range of weeds and grasses in crops and pastures.DO NOT apply by aircraft (except for sugar cane)

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 31569/57854
  • Authorization date:
  • 15-01-2013
  • Last update:
  • 15-06-2017

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

·

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_.-,__

.::__:_

-~--

-·------------

Main panel/abel

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

ASULOX®

SELECTIVE HERBICIDE

ACTIVE CONSTITUENT: 400

ASULAM

present

the sodium salt

Approved

control

bracken

fern

pastures,

grasses

sugarcane,

range

weeds

grasses

crops

pastures

specified

DIRECTIONS FOR USE Table

IMPORTANT:

READ

ATTACHED

BOOKLET

BEFORE

CONTENTS

5 L,

L, 110

®Trademark

UNITED PHOSPHORUS LTD

ABN 76 066

Suite 416, Level

14 Lexington Drive

Norwest Business Park, Bella Vista NSW

2153

TELEPHONE (02) 8824 7277

FACSIMILE (02) 8814 6469

BATCH

DOM:

APVMA Approval

31569/57854

Asulox Selective Herbicide draft label and leaflet

31569/1

page

Version

1 21/09/12

Ancillary panel/abel

Asulox Selective Herbicide

STORAGE AND DISPOSAL

Keep out

reach

children. Store in the closed, original container

a cool, well-

ventilated area. Do not store for prolonged periods in direct sunlight.

Triple

preferably pressure rinse containers before disposal. Add rinsings to the spray tank.

Do not dispose

undiluted chemicals

site. If recycling, replace cap and return

clean

containers to recycler

designated collection point. If not recycling, break,

crush, or puncture and bury empty containers in a local authority landfill.

no landfill

is available, bury the empty containers below 500 mm in a disposal pit specifically

marked and set up for this purpose clear

waterways, desirable vegetation and tree

roots. Empty containers

and.

product should not be burnt.

For refillable containers

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

supply

designated collection point for refill or storage.

SAFETY DIRECTIONS

Avoid contact with eyes and skin. Do not inhale spray mist. If product on skin,

immediately wash area with soap and water. After use and before eating, drinking

smoking, wash hands, arms and face thoroughly with soap and water.

FIRST AID

poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia

1311

MATERIAL SAFETY DATA SHEET

Additional information is listed

the Material Safety Data Sheet available froin the

supplier.

CONDITIONS OF SALE: United Phosphorus accepts responsibility for the consistent

quality of the product; however since the use and application of the product

beyond control, the company accepts

responsibility whatsoever for any loss,

damage or other result following the use

the product whether used in accordance

with directions or not; other than those mandatorily imposed by statutes, the liability

is limited to the replacement

the goods and is conditional upon a claim made in

writing and, where necessary, a sufficient part of the goods being returned for proper

examination by the company within thirty days of sale.

Asulox® is a registered trademark

Bar Code

Drummuster logo

Asulox Selective Herbicide draft label and leaflet

31569/1

110 L

page 2

Version 1 21/09/12

<

Main pane/leaflet

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

ASULOX®

SELECTIVE HERBICIDE

ACTIVE CONSTITUENT: 400 g/L ASULAM

present as the sodium salt

For the control

of

bracken fern in pastures, grasses in sugarcane, and a

range

of

weeds and grasses

in

crops and pastures as specified in the

DIRECTIONS FOR USE Table

IMPORTANT: READ THIS BOOKLET BEFORE USE

STORAGE AND DISPOSAL

Keep out

reach of children. Store

the closed, original container

a cool, well-

ventilated area. Do not store for prolonged periods

direct sunlight. Triple or.

preferably pressure rinse containers before disposal. Add rinsings to the spray tank.

· Do not dispose

undiluted chemicals on site. If recycling, replace cap and return

clean containers to recycler or designated collection point. If not recycling, break,

crush,

puncture and bury empty containers

a local authority landfill. If no landfill

is available, bury the empty containers below 500 mm

a disposal pit specifically

marked and set up for this purpose clear

waterways, desirable vegetation and tree

roots. Empty containers and product should not be burnt.

For refillable containers

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

supply or designated collection point for refill or storage.

SAFETY DIRECTIONS

Avoid contact with eyes and skin. Do not inhale spray mist. If product on skin,

immediately wash area with soap and water. After use and before eating, drinking or

smoking, wash hands, arms and face thoroughly with soap and water.

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia

1311

MATERIAL SAFETY DATA SHEET

Additional information is listed

the Material Safety Data Sheet.

CONDITIONS OF SALE: United Phosphorus accepts responsibility for the consistent

quality

the product; however since the use and application

the product is

beyond control, the company accepts no responsibility whatsoever for any loss,

damage or other result following the use of the product whether used in accordance

with directions or not; other than those mandatorily imposed by statutes, the liability

is limited to the replacement

the goods and is conditional upon a claim made

Asulox Selective Herbicide draft label and leaflet

31569/ 1

page 3

Version 1 21/09/12

writing and, where necessary, a sufficient part of the goods being returned for proper

examination by the company within thirty days

sale.

Asulox®

a registered trademark

APVMA Approval No.

31569/57854

Asulox Selective Herbicide draft label and leaflet

31569/1

5.L,

110 L

page 4

Version 1 21/09/12

>

DIRECTIONS FOR USE

RESTRAINTS:

Ancillary pane/leaflet

apply by afrcraft (except for sugarcane).

apply

rain is likely to fall within 3 hours (24 hours for bracken).

CROP

WEEDS

RATE

STATE

·coNTROLLED

Apple

Docks

Boom

NSW,

Orchards

(Rumex

spp.)

Sprayer

Vic, Tas,

4.2 L

220 to

·sA,WA

440 L water/ha

only

Knapsack

Hand Lance

1 part to 200

parts water.

Hops

Broad leaf dock

3.5 to 5.0 L

Vic, Tas

(Rumex obtusifolius),

220 to 440 L

only

curled dock

(Rumex

water/ha

crispus),

fiddle dock

(Rumex pulcher)

Lucerne-

Docks

(Rumex

spp.)

Boom

All States

established

Sprayer

2.8 to 4.2 L

220 to 440 L

water/ha

Onions

Docks

(Rumex

spp.)

Knapsack

Tas only

Hand Lance

1 part to 200

parts water

Oilseed

Broad leaf dock

2.5 L

220 to

Tas only

Poppies

(Rumex obiusifolius),

440 L water/ha

curled dock

(Rumex

crispus)

Asulox Selective Herbicide draft label and leaflet

31569/1

110 L

CRITICAL COMMENTS

Apply when docks are actively growing and

have fully expanded leaves, just before

flowering shoots emerge. With knapsack or

hand lance, ensure uniform coverage but do

not spray to run-off. Apply only to established

trees.

DO NOT graze the area to be sprayed for 7

days before and

days after application.

Apply before the hop plants have emerged.

Apply the higher rate where Fiddle

Dock

present or where docks are mainly old,

established plants.

Lucerne should be at least one year old. Apply

when docks are actively growing and have fully

expanded leaves, just before flowering shoots

emerge. Apply lower rate

Curled Dock and

Broad leaf Dock are present. Apply higher rate

other docks are present.

DO NOT apply

spring

pasture is intended

for seed production.

Apply when docks are actively growing and

have fully expanded leaves, just before

flowering shoots emerge. Ensure uniform

spray coverage

docks but do not spray to

run-off. DO NOT apply as an overall spray as

crop damage may result. Sprayed onions may

show a slight yellowing but they will normally

recover quickly

good growing conditions

exist.

Crop

stage: Spray any time after

4 to 6

leaf stage.

Weed

stage:

Apply when docks are actively

growing and have fully expanded leaves, just

before flowering shoots emerge. The range

control is extended with a spray programme

combination with ethofumesate as

recommended by poppy contracting

companies or the Department

Primary

Industries, Tasmania.

page 5 of 10

Version 1 21/09/12

Ancillary pane/leaflet continued

CROP

WEEDS

RATE

STATE

CONTROLLED

Pastures

Common bracken

Boom

S12ra)ler

All States

established &

(Pteridium

12.0 L

ir.nproved pastures

esculentum)

Plus

Chewing's

BP Ulvapron® (2%

Fescue, Cocksfoot,

spray volume)

Perennial Ryegrass,

110to330L

Red Clover, Tall

water/ha

Fescue, White

Clover

Motorised

Mister

12.0 L

Plus

BP Ulvapron (2%

spray volume)

to 80 L water/ha

Kna12sack

Hand

Lance

Plus

BP Ulvapron (2%

spray volume)

L water.

Carpet

Wiper

Vic only

5.0 L

Plus

BP Ulvapron (2%

spray volume)/ha

Broad leaf dock

Boom

S12ra)ler

All States

(Rumex

2.8 L

220 to 440

obtusifolius),

L water/ha

curled dock

(Rumex crispus)

Asulox Selective Herbicide draft label and leaflet

31569/1

110 L

CRITICAL COMMENTS

Temporary scorch is likely to occur

perennial

pastures. Apply during late April

early June

after the autumn re-growth has fully expanded,

and before the first frosts

the season. Where

old mature fronds exist, the Bracken should

slashed or burned during October or

November

the year prior to spraying. Results

are first seen as a lack

spring regrowth.

Ensure uniform coverage

spray over

Bracken. With knapsack or hand lance, spray

to give complete coverage

fronds but do not

spray to runoff.

apply

rain is likely within 24 hours.

For East Gippsland district only.

apply the

recommended rate it is necessary to select

appropriate combination

flow rate, tractor

speed and herbicide dilution. Refer to General

Instructions for details. This rate will control

bracken growing at a density

25 fronds per

square metre. The bracken should be slashed

during late spring or early summer

the year

prior to spraying to ensure regeneration of

fronds

similar age. The bracken should then

be wiped in the following autumn before the

first frosts

the season when the regenerated

fronds are fully mature. Where fronds are

variable height

occur

dense infestation or

clumps, some plants may not be contacted by

the herbicide solution. In these cases, repeat

treatments may be necessary.

Apply when docks are actively growing and

have fully expanded leaves, just before

flowering shoots emerge. Slight yellowing

some pasture species may occur but they will·

normally recover quickly if good growing

conditions exist. Damage to Strawberry Clover

and Subterranean

Clover is likely. A follow-up

spray may be required to control subsequent

germinations

seedlings which occur

established stands

mature docks. Pastures

should not

grazed for 2 to 3 weeks before

spraying to allow sufficient growth

docks and

to minimise the check to pastures.

apply

spring if pasture

intended

for seed production.

page 6

Version 1 21/09/12

Ancillary pane/leaflet continued

CROP

WEEDS

RATE

STATE

CONTROLLED

Perennial

Group

160 to

NSW,

Ryegrass

Docks*

(Rumex

spp.),

220 L water/ha

Vic, Tas,

for seed

false brome

SA only

production

(Brachypodium

distach yon),

rat's tail fescue

(Vulpia myuros),

shivery grass

(Briza minor),

silvery hair grass

(Aira

caryophyl/ea),

soft brome

(Bromus hordeaceus),

squirrel tail fescue

(Vulpia bromoides),

sub clover

(Trifolium

subterraneum)

Group

Madrid brome

(Bromus madritensis),

prairie grass

(Bromus catharticus),

sorrel

(Rumex

acetosella),

sterile brome

(Bromus sterilis),

annualpoa

(winter grass)

(Poa annua),

yorkshire fog

(Holcus /anatus)

Potatoes

Docks

(Rumex

spp.)

Boom

Vic, Tas

Sprayer

only

220 to·

440 L water/ha

Asulox Selective Herbicide draft label and leaflet

31569/1

110 L

CRITICAL COMMENTS

Apply to established crops in the autumn (late

April to early June). The crop will

show

signs

yellowing 5 to 6 weeks after spraying.

A reduction

total herbage production for 3 to

6 months will be experienced. Annual clovers

will be affected.

DO NOT apply to cultivar Medea Ryegrass as

crop yields may be affected.

NOT apply

spring as crop

damage

will

result.

Group A weeds are susceptible and Group B

weeds are moderately susceptible

recommended rate.

*Apply

when docks are actively growing and

have fully expanded leaves, just before

flowering

shoot~

emerge but before the

emergence

the flowering shoots.

Apply when docks are actively growing and

have fully expanded leaves, just before

flowering shoots emerge. Apply before the

potato foliage obscures the docks.

page 7

Version 1 21/09/12

Ancillary pane/leaflet continued

CROP

WEEDS

RATE

STATE

CRITICAL COMMENTS

CONTROLLED

SugarCane

Awnless barnyard grass

Boom

Qld,

Crop

stage: Apply post-emergence

plant or

(Echinoch/oa colona),

Sprayer

NSW,

ratoon cane.

barnyard grass

8.5 L

200 to

WA,f';IT

(Echinochloa crus-

400 L water/ha

only

Weed stage: Apply when weeds are actively

gal/t),

growing, before flowering and before they

crab grass

Aircraft

exceed 200 to 250 mm

height unless

(Digitaria sanguinalis),

8.5 L

a min.

otherwise indicated. Optimal results will be

crowsfoot grass

22 L water/ha.

obtained when the relative humidity is high

(Eieusine indica),

(over 80%) and temperature above 17°C.

green summer grass

Spot

Residual control of grasses germinating from

(Brachiaria

Application

seed will persist for 6 to

weeks, depending

subquadripara),

in 9.8

on field conditions.

giant paspalum

L of water.

(Paspalum urvillet),

Surfactant: Add a non-ionic wetting agent at

hairy panic

mixtures

250 mU100 L spray to improve wettability and

(Panicum effusum},

with Actril® DS

coverage

reduce spray runoff.

itch grass

use at least 55

(Rottboellia

L water/ha.

Directed

application:

Ideally the spray should

cochinchinensis},

be directed to minimise coverage of the cane

johnson grass

foliage. Aircraft application may

necessary

(Sorghum halepense),

salvage situations and could result

some

para grass

crop damage.

(Brachiaria mutica),

summer grass

Caution: Certain varieties have not been

(Digitaria ci/iaris)

screened for tolerance to this product. Treat a

Guinea grass

small area first,

the same technique

that

(Panicum maximum)

to be used commercially to check tolerance.

(Seedlings only -

up to

Variety Q68 should not be treated.

10 em)

#With

knapsack or hand lance, ensure uniform

coverage but do not spray to runoff.

NOT TO

USED FOR

PURPOSE, OR IN

MANNER, CONTRARY TO

THIS

LABEL

UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION.

WITHHOLDING PERIOD

Apple

Orchards,

Lucerne,

Onions,

Pastures,

Perennial

Ryegrass:

GRAZE

STOCK

FOOD·

DAYS

AFTER

APPLICATION.

Asulox Selective Herbicide draft label and leaflet

31569/1

110 L

page 8 of 10

Version 1 21/09/12

Ancillary pane/leaflet continued

GENERAL INSTRUCTIONS

Note

The performance

Asulox may be reduced

mixed with water which has a pH

less than

Resistant Weeds Warning:

Asulox Selective Herbicide is a member

the Carbamate group

herbicides and

has inhibitor

dihydropteroate synthase (DHI inhibitor) mode

action. For weed

resistance management Asulox

a Group R herbicide. Some naturally occurring

weed biotypes resistant to Asulox and other Group R herbicides may exist through

normal genetic variability

any weed population. The resistant individuals can

eventually dominate the weed population

these herbicides are used repeatedly.

These resistant weeds will not be controlled by Asulox or other Group R herbicides.

Since occurrence

resistant weeds is difficult to detect prior to use, United

Phosphorus Ltd accepts no liability for any losses that may result from the failure

Asulox to control resistant weeds.

Mixing

Half fill spray tank with clean water. Add the required amount of product to the spray

tank and top up to required volume with water. Thoroughly agitate before applying.

When using high volume applications, maintain agitation during application. DO NOT

leave prepared spray

the tank overnight. If sprays are prepared

a bulk mixing

tank at a central point, always stir thoroughly before drawing from the tank.

Except for bracken control and sugar cane use, DO NOT add a wetting agent or crop

damage may result.

Application

Boom Sprayer

Apply a minimum

100 litres of water per hectare.

Aerial Application

Apply a minimum

28 litres

water per hectare (lower rates have not been tested).

apply tank mixes from aircraft.

Carpet wiper

Calibrate the wiper equipment by adjusting the flow rate and tractor speed to ensure

the herbicide is delivered at the recommended rate.

25 litre tank, the following rates can be used to deliver the recommended rate

Asulox per hectare.

Asulox

BP Ulvapron

Water

Speed

Travel

Flow Rate

4.0 Litres

0.5 Litre

20.5 Litres

10 km/hr

1 Litre/minute

Asulox Selective Herbicide draft label and leaflet

31569/1

page 9

Version 1 21/09/12

Ancillary pane/leaflet continued

Compatibility

This product

compatible

the spray tank with Actril

Ulvapron and atrazine.

Mixtures should not be left overnight before spraying. As formulations of other

manufacturers' products are beyond the control

United Phosphorus Ltd, all

mixtures should be tested prior to mixing commercial quantities.

PROTECTION

OF

CROPS, NATIVE AND

OTHER

NON-TARGET PLANTS

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

expected

cause drift onto nearby plants and adjacent crops, crop-lands or pasture.

PROTECTION

OF

WILDLIFE, FISH,

CRUSTACEANS

AND ENVIRONMENT

NOT contaminate dams, ponds, waterways or drains with the product or used

container.

Asuio/

and Actril® are registered trademarks.

UNITED PHOSPHORUS LTD

ABN 76 066

Suite 416, Level4, 14 Lexington Drive

Norwest Business Park, Bella Vista NSW 2153

TELEPHONE (02) 8824 7277

FACSIMILE (02) 8814 6469

Asulox Selective Herbicide draft label and leaflet

31569/1

5 L, 10 L, 20 L, 110 L

page 10

Version 1 21/09/12

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9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

2-11-2018

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay Issues Allergy Alert on Undeclared Milk In Select Smartfood Delight Sea Salt Flavored Popcorn

Frito-Lay announced a voluntary recall of select 1/2 oz. bags of Smartfood Delight Sea Salt Flavored popcorn because they were inadvertently filled with cheese flavored tortilla chips that contain undeclared milk ingredients. The recalled bags were sold only in the two variety packs listed below.

FDA - U.S. Food and Drug Administration

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that can cause serious and sometimes-fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

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

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

8-9-2018

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination

Steve’s Real Food of Salt Lake City, Utah is voluntarily recalling one lot of 5lb Turducken Recipe, one lot of 2lb Quest Emu Diet, and one lot of 2lb Quest Beef Diet, due to their possible Salmonella and/or L. mono contamination.

FDA - U.S. Food and Drug Administration

31-8-2018

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

Public Notification: PremierZen Gold 4000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use PremierZen Gold 4000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

15-8-2018

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts

Salt & Straw Ice Cream is voluntarily recalling a limited number of its Chocolate Gooey Brownie pints because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of a serious or life threatening allergic reaction if they consume this product. The product is safe to consume unless you have a peanut allergy or sensitivity. No illnesses have been reported to date in connection with this problem.

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

14-6-2018

Blokhuis: maak postnatale depressie bespreekbaar

Blokhuis: maak postnatale depressie bespreekbaar

In Nederland ontwikkelen jaarlijks ruim 23.400 vrouwen een depressie na de bevalling. Dat is 1 op de 8 moeders. Velen van hen durven hun situatie niet aan te kaarten. Zij zijn bang om gezien te worden als een slechte moeder (47,4%) en willen anderen niet belasten (52,2%), blijkt uit een peiling onder vrouwen die (signalen van) een postnatale depressie hebben gehad. Hierdoor blijft postnatale depressie, ook wel postpartum depressie (PPD) genoemd, te vaak onbesproken. Daarom geeft staatssecretaris Paul Blo...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

19-6-2015

Global operation against illicit medicines completed

Global operation against illicit medicines completed

A global medicine operation results in 156 arrests and shutdown of more than 2,400 websites.

Danish Medicines Agency

20-12-2018


Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-c

Orphan designation: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate salt, Treatment of beta-thalassaemia intermedia and major, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

19-12-2018


Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Orphan designation: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt, Treatment of acute myeloid leukaemia, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (TESARO Bio Netherlands B.V.)

EU/3/10/760 (Active substance: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt) - Transfer of orphan designation - Commission Decision (2018)8636 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002385

Europe -DG Health and Food Safety

26-11-2018


Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Withdrawn application: HopGuard Gold, purified semi-solid extract from Humulus lupulus L. containing approximately 48% of beta acids as potassium salts, Date of withdrawal: 12/04/2018, Initial authorisation

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

28-8-2018

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Pharm Research Associates (UK) Limited)

EU/3/18/2057 (Active substance: 1-(2-hydroxyethyl)-8-{[5-(4-methylpiperazin-1-yl)-2-(trifluoromethoxy) phenyl]amino}-4,5-dihydro-1H-pyrazolo[4,3-h]quinazoline-3-carboxamide fumarate salt) - Orphan designation - Commission Decision (2018)5729 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/051/18

Europe -DG Health and Food Safety

25-7-2018

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist.  https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

#FDA issues updated safety communication for Zoll LifeVest 4000 regarding “Message Code 102,” and updated patient checklist. https://go.usa.gov/xUEPn  #MedicalDevices

FDA - U.S. Food and Drug Administration

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Gilead Sciences Ireland UC)

EU/3/11/888 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3802 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/152/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Gilead Sciences Ireland UC)

EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Gilead Sciences Ireland UC)

EU/3/11/886 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3799 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/019/11/T/03

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety