OUST

Main information

  • Trade name:
  • OUST HERBICIDE
  • Pharmaceutical form:
  • Wettable
  • Units in package:
  • 1kg,1.5kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • BAYER CROPSCIENCE

Documents

Localization

  • Available in:
  • OUST HERBICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • COMMERCIAL AREA - GENERAL | INDUSTRIAL LAND OR AREA | RAILWAY LINE WEED CONTROL | RIGHT-OF-WAY - GENERAL | ROADSIDE WEED CONTROL
  • Therapeutic area:
  • Group B Herbicide
  • Therapeutic indications:
  • AFRICAN LOVEGRASS | ANNUAL OR WIMMERA RYEGRASS | BARNYARD GRASS OR WATER GRASS | BLUE BILLYGOAT WEED | CAPEWEED | COLUMBUS GRASS | COUCH GRASS | DANDELION - TARAXACUM OFFICINALE | DOCK | ELASTIC GRASS | GUINEA GRASS | JOHNSON GRASS | KIKUYU GRASS | LONG STORKSBILL, CORKSCREW | PASPALUM | PATERSON'S CURSE | PHALARIS | PRAIRIE OR ANNUAL PRAIRIE GRASS | SILVER GRASS OR RAT'S-TAIL FESCUE | SPEAR OR BLACK THISTLE | SQUIRREL-TAIL FESCUE OR SILVER GRASS | SUBTERRANEAN CLOVER | SUMMER OR CRAB GRASS | TURNIP WEED | WHITE CLOVER | WILD OR BLACK OAT | WINTER GRASS | ANNUAL BLUE GRASS | ANNUAL POA | ANNUAL SUMMER GRASS | AUSTRALIAN PHALARIS | BLUE TOP | BROADLEAF DOCK | BROME FESCUE | BROMUS CATHARTICUS | BROMUS STAMINEUS | BROMUS WILDENOWII | COMMON DANDELION | CURLED DOCK | ECHIUM LYCOPSIS | ECHIUM SPP. | ENGLISH DANDELION | EUROPEAN DANDELION | FESTUCA BROMOIDES | FESTUCA MYUROS | GIANT MUSTARD | GOOSE GRASS | GREEN COUCH | INDIAN COUCH | LOVE GRASS | PERENNIAL COUCH | PERENNIAL PHALARIS | PHALARIS TUBEROSA-OLD SI NAM
  • Product summary:
  • For the control of certain annual and perennial grasses and broadleaf weeds in commercial and industrial areas around agricultural buildings and rights of way.See RESTRAINTS on labels

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 31863/102761
  • Authorization date:
  • 18-06-2015
  • Last update:
  • 15-06-2017

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

For Official Use Only

Page 1 of 4

e-Label Application (DRAFT)

Company Name:

Product Name:

eLabel Application No:

APVMA Approval No:

BAYER CROPSCIENCE PTY LTD

OUST HERBICIDE

DCNV-19012141E17

31863/102761

Product ID:

31863

Version No:

Application Started:

2015-May-25 13:07:21

Version Created:

2015-Jun-18 08:43:22

Started By:

Margaret Fitzgerald

Printed:

2015-Jun-18 08:55:29

Label Name:

OUST HERBICIDE

Signal Headings:

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Constituent

Statements:

750 g/kg SULFOMETURON-METHYL

Mode of Action:

GROUP

B

HERBICIDE

Statement of

Claims:

For the control of certain annual and perennial grasses and broadleaf weeds in commercial

and industrial areas; around agricultural buildings and rights of way as per the Directions

for Use.

Net Contents:

1.5kg

Restraints:

DO NOT apply to drainage ditches and channels.

DO NOT apply during periods of intense rainfall, or to soils saturated with water, as off-

target movement may occur.

DO NOT store tank mixes of Oust with other materials for more than 24 hours as product

breakdown may occur.

DO NOT store a suspension of Oust for more than two days as it may degrade, particularly

in acid solutions.

Directions for Use:

This section contains file attachment.

File Name: Oust Directions for Use 2015.05.25.pdf

File Size: 229145 bytes

Other Limitations:

RLP

APPROVED

For Official Use Only

Page 2 of 4

Withholidng

Periods:

NOT REQUIRED WHEN USED AS DIRECTED.

Trade Advice:

General

Instructions:

Oust is a soil residual herbicide with some knockdown action. It controls susceptible weeds

through both post-emergence and pre-emergence (residual) action. Oust may be applied

pre-emergence or post-emergence to the weeds; best results are obtained if application is

made before or during the early stages of weed growth.

Adequate soil moisture is required for Oust to be activated so it can provide optimum weed

control. Under limited rainfall conditions, Oust may not provide satisfactory control of hard-

to-kill annuals and perennial weeds.

The higher use rates give longer term residual control. The degree of control and duration

of effect will vary with the rate of application, soil texture, organic matter content, soil pH,

rainfall and other environmental conditions.

As soil pH increases the rate of Oust breakdown decreases so that longest term residual

control is obtained on alkaline soils. As soil moisture increases the rate of Oust breakdown

increases, so that longest term residual control is obtained when rainfall is low. As soil

organic matter content increases the rate of Oust breakdown increases, so that longest

term residual control is obtained in low organic matter soils.

Spray Preparation

Oust is a dry flowable formulation to be mixed with water and applied as a spray. Partially

fill the spray tank with water. Using the graduated measuring cylinder provided, measure

the amount of Oust required for the area to be sprayed. Do not shake the Oust down as

the measuring cylinder is graduated for Oust in an uncompacted state. Add the correct

amount of Oust to the spray tank with the agitation system engaged. Top up to the correct

volume with water. THE MATERIAL MUST BE KEPT IN SUSPENSION AT ALL TIMES BY

CONTINUOUS AGITATION.

NB: The measuring cylinder provided is graduated in grams of Oust only. Do not use for

measuring other materials.

In tank mixes, Oust must be in suspension before adding the companion herbicide or

surfactant.

Where prepared spray solutions have been allowed to stand, thoroughly reagitate before

using.

Use of Surfactant

Always add a non-ionic surfactant at the rate of 0.25 % v/v (e.g. BS 1000 at 250 mL/100L)

when Oust is used alone. When Oust is tank mixed with glyphosate, no surfactant addition

is necessary.

Spraying Equipment

DO NOT apply by aerial application equipment or mist spray application equipment.

Boom Spray

Oust is recommended for application by ground spraying equipment only. Use a boom

spray (or off-centre nozzle if necessary) properly calibrated to a constant speed and rate of

delivery to ensure thorough coverage and a uniform spray pattern and rate of application

over the area to be treated. Apply a minimum of 50 L prepared spray/ha.

Handgun/Knapsack

For Official Use Only

Page 3 of 4

Wet the foliage of the weeds present but not excessively so as to cause run-off. Handgun

- Use 1000 - 2000 L of spray mix per hectare. Oust residues in the spray tank can damage

sensitive plants. Following an Oust application the spray tank should not be used for other

than non-crop applications.

Compatibility

Oust is compatible with Velpar DF, bromacil, diuron and glyphosate. As formulations of

other manufacturers' products are beyond the control of Bayer CropScience Pty Ltd, all

mixtures should be tested prior to mixing commercial quantities.

Sprayer Cleanup

Oust residues in the spray tank can damage sensitive plants. It is recommended that a

sprayer be dedicated to the use of Oust. Where equipment is also used for crop spraying,

it is particularly important that all traces of Oust be removed from mixing and spraying

equipment immediately after spraying. The recommended sprayer cleanup is as follows:

1. Drain tank, then flush tank, boom, filters and hoses with clean water for a minimum of 10

minutes.

2. Fill the tank with clean water and add 300 mL chlorine bleach (containing 4 % chlorine)

per 100 L water. Flush through boom, filters and hoses, then allow to sit for 15 minutes with

agitation engaged, then drain.

3. Repeat Step 2.

4. Nozzles and screens should be removed and cleaned separately. To remove traces of

chlorine bleach, rinse the tank thoroughly with clean water and flush through boom, filters

and hoses.

CAUTION: DO NOT use chlorine bleach with ammonia.

Resistance

Warning:

Oust Herbicide is a member of the sulfonylurea group of herbicides. This product has the

ALS inhibitor mode of action. For weed resistance management, this product is a Group

B herbicide. Some naturally occurring weed biotypes resistant to this product and other

Group B 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 B herbicides. Since the occurrence of resistant weeds is difficult to detect prior to

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

failure of this product to control resistant weeds.

Precautions:

Protections:

PROTECTION OF CROPS, NATIVES AND OTHER NON-TARGET PLANTS

DO NOT apply to drainage ditches (including roadside ditches and table drains) and

channels as some of the chemical may wash away in drainage water and be deposited in

areas where it may cause damage to desirable trees and other plants.

DO NOT apply under weather condition, or from spraying equipment, that may cause spray

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

land scheduled to be planted to crops of pastures, as injury to the crop or pasture may

occur.

PROTECTION OF LIVESTOCK

DO NOT graze treated areas or cut for stock food.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT

DO NOT apply or drain of flush equipment on or near desirable trees or other plants, or

on areas where their roots extend, or in locations where the chemical may be washed or

moved into contact with their roots.

For Official Use Only

Page 4 of 4

DO NOT contaminate any body of water by spraying, cleaning of equipment, disposal of

waste, or run-off from treated areas. If accidental contamination does occur, the water must

not be used for irrigation.

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-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 deliver empty packaging to an approved waste management facility.

If an approved waste management facility is not available, bury the empty packaging 500

mm below the surface in a disposal pit specifically marked and set up for this purpose,

clear of waterways, desirable vegetation and tree roots, in compliance with relevant local,

state or territory government regulations. Do not burn empty containers or product. Do not

re-use empty containers for any other purpose.

Safety Directions:

Avoid contact with eyes and skin. Do not inhale dust. Wash hands after use.

First Aid

Instructions:

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

First Aid Warnings:

DIRECTIONS FOR USE

OUST

®

HERBICIDE (31868)

Page 1 of 1

FOR ALL STATES

SITUATION

WEEDS CONTROLLED

RATE

CRITICAL COMMENTS

Boom

g/ha

Handgun

g/100 L

Knapsack

g/15 L

Commercial and

industrial areas,

around agricultural

buildings, rights-of-

way including road

sides, around

guide-posts, rail-

ways, power lines

and telephone

lines.

Easy-to-kill Annual Weeds

Grasses - Annual ryegrass,

Barnyard grass, Summer

grass/Crab grass, Wild oats,

and Winter grass.

Broadleafs - Blue billygoat

weed, Capeweed,

Corkscrew/Erodium,

Paterson's curse/Salvation

Jane, Subterranean clover and

Turnip weed

Easy-to-Kill Perennial Weeds

Grasses – Prairie grass

Broadleafs - Dandelion, Dock,

White clover

200 or 400

20 or 40

3 or 6

For roadside applications confine treatment to the area between

the edge of the bitumen and the roadside shoulder. For weeds

advanced beyond the 4 leaf stage or when more rapid knockdown

is required, tank mix with a registered glyphosate product in

accordance with label recommendations. Always add a surfactant

- except when tank mixing with a glyphosate herbicide.

Use the higher rate for longer term residual control.

Use the higher rate plus a glyphosate herbicide (in accordance

with its label recommendations), for dense weed infestations and

where weeds are greater than 15 cm in height or diameter.

For handgun or knapsack application, apply the spray evenly to

the required area. Spray to wet the foliage of the weeds present,

but not excessively so as to cause run-off. Over application may

reduce knockdown results and significantly increase period of

residual control.

Hard-to-kill Annual Weeds

Grasses - Rat's tail fescue,

Squirrel tail fescue.

Broadleaf - Black

Thistle/Spear Thistle

For roadside applications confine treatment to the area between

the edge of the bitumen and the roadside shoulder. Always tank

mix with a glyphosate herbicide in accordance with its label

directions - a surfactant is not required. Use the higher rate plus a

glyphosate herbicide (in accordance with its label

recommendations), for dense weed infestations and where weeds

are greater than 15 cm in height or diameter.

Use the higher rate for longer term residual control.

Hard-to-Kill Perennial Weeds

Grasses - African lovegrass,

Columbus grass, Couch,

Elastic grass, Guinea grass,

Johnson grass, Kikuyu,

Paspalum and Phalaris.

400 or

40 or 80

6 or 12

For handgun or knapsack application apply the spray evenly to

the required area. Spray to wet the foliage of the weeds present,

but not excessively so as to cause run-off. Over application may

reduce knockdown results and significantly increase period of

residual control.

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

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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

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

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae 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 xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO 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 microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

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

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB 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 acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

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

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

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW 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. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) 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 glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

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

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

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

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 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 levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

11-1-2019


Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Orphan designation: 6-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate, Treatment of cystic fibrosis, 26/10/2018, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Orphan designation: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile, Treatment of medullary thyroid carcinoma, 26/10/2018, Positive

Europe - EMA - European 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: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate, Treatment of glioma, 24/08/2018, Positive

Orphan designation: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate, Treatment of glioma, 24/08/2018, Positive

Orphan designation: (3R,3aS,9R,9aS,9bS)-3-((dimethylamino)methyl)-9-hydroxy-6,9-dimethyl-3,3a,4,5,7,8,9,9a-octahydroazuleno[4,5-b]furan-2(9bH)-one fumarate, Treatment of glioma, 24/08/2018, Positive

Europe - EMA - European Medicines Agency

11-12-2018


Methylphenobarbital: List of nationally authorised medicinal products - PSUSA/00002025/201803

Methylphenobarbital: List of nationally authorised medicinal products - PSUSA/00002025/201803

Methylphenobarbital: List of nationally authorised medicinal products - PSUSA/00002025/201803

Europe - EMA - European Medicines Agency

7-12-2018


Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

22-11-2018


Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lym

Orphan designation: 4-(4-{[2-(4-Chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl]methyl}piperazin-1-yl)-N-({3-nitro-4-[(tetrahydro-2H-pyran-4-ylmethyl)amino]phenyl}sulfonyl)-2-(1H-pyrrolo[2,3-b]pyridin-5-yloxy)benzamide (venetoclax), Treatment of chronic lymphocytic leukaemia, 06/12/2012, Withdrawn

Europe - EMA - European Medicines Agency

22-11-2018

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Active substance: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione) - Transfer of orphan designation - Commission Decision (2018)7813 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000001966

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Celgene Europe B.V.)

EU/3/16/1640 (Active substance: 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol methanesulfonate) - Transfer of orphan designation - Commission Decision (2018)6989 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/253/15/T/01

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Active substance: epoetin alfa) - Centralised - 2-Monthly update - Commission Decision (2018)5860 of Tue, 04 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/727/WS/1406

Europe -DG Health and Food Safety