OCTAVE

Main information

  • Trade name:
  • OCTAVE WP FUNGICIDE
  • Pharmaceutical form:
  • Wettable
  • Units in package:
  • 1kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • FMC AUSTRALASIA

Documents

Localization

  • Available in:
  • OCTAVE WP FUNGICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • FIELD GROWN LETTUCE (CLOSED HEAD VARIETI | MANGO | MUSHROOM CROP | NURSERY GROWN LETTUCE-PRIOR TO TRANSPLAN | PANSY OR VIOLA | P
  • Therapeutic area:
  • Group 3 Fungicide
  • Therapeutic indications:
  • ANTHRACNOSE - M. PANATTONIANUM | ANTHRACNOSE ON VIOLET | ANTHRACNOSE SPOT ON VIOLET | BLOSSOM BLIGHT - C. GLOEOSPOROIDES | COBWEB DISEASE | COLLETOTRICHUM CROWN ROT | DAMPING OFF - RHIZOCTONIA SPP. | DRY BUBBLE DISEASE ON MUSHROOM | STEM-TIP DIEBACK OR CANKER ON PROTEA | STOLON ROT | WET BUBBLE DISEASE ON MUSHROOM | ANTHRACNOSE BLOSSOM BLIGHT | CROWN ROT - COLLETOTRICHUM | SOIL FUNGI | VERTICILLIUM FUNGICOLA VAR
  • Product summary:
  • For the control of certain diseases of mangoes, mushrooms, proteas, violas and some lettuce varieties.Apply only to closed-head lettuce varieties.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 30485/0303
  • Authorization date:
  • 13-03-2003
  • Last update:
  • 15-06-2017

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

Octave WP

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Octave

®

WP FUNGICIDE

Active Constituent:

462 g/kg PROCHLORAZ present as the

manganese chloride complex

GROUP

C

FUNGICIDE

For the control of certain diseases of mangoes, mushrooms, proteas, violas and some lettuce varieties

GENERAL INSTRUCTIONS

Fungicide Resistance Warning

Octave WP Fungicide is a member of the imidazole group of fungicides. For fungicide resistance management Octave

is a Group C fungicide.

Some naturally occurring individual fungi resistant to Octave and other Group C fungicides may exist through normal

genetic variability in any fungal population. The resistant individuals can eventually dominate the fungi population if

these fungicides are used repeatedly. These resistant fungi will not be controlled by Octave and other Group C

fungicides, thus resulting in a reduction in efficacy and possible yield loss.

Since the occurrence of resistant fungi is difficult to detect prior to use, Bayer CropScience Pty Ltd accepts no liability

for any losses that may result from the failure of Octave to control resistant fungi.

Export of treated produce

Growers should note that MRLs or import tolerances do not exist in all markets for edible produce treated with Octave.

If you are growing edible produce for export, please check with Bayer CropScience Pty Ltd for the latest information

on MRLs and import tolerances BEFORE using Octave.

Mixing

(a) Mushrooms

Pre-casing application

Thoroughly mix with the water used to wet the peat and incorporate with the casing material, ensuring even distribution.

Spray application

Pre-mix the powder in a small volume of water. Add this pre-mix to the required volume of water in the spray tank with

the agitator running to ensure thorough mixing.

(b) Lettuce, Proteas, Strawberry Runners, Violas: As for `Spray application' above.

(c) Mangoes: Pre-mix the powder in a small volume of water. Add this pre-mix to three-quarters of the required volume

of water in the spray tank with the agitator running to ensure thorough mixing. Then add the mancozeb product and

complete filling of the tank. Continue to agitate while spraying and if suspension is allowed to stand. Do NOT allow spray

mix to stand overnight.

Application

Good disease control requires even, thorough coverage of the target area. Application should be made using appropriate

spray equipment and sufficient water to provide adequate penetration and coverage. Equipment settings and water

volume may need to vary, depending on the growth stage of the crop.

Continue to agitate while spraying and if suspension is allowed to stand.

Special Instructions for Mangoes

Dilute Spraying

Use a sprayer designed to apply high spray volumes, up to the point of run-off and matched to the crop being

sprayed.

Set up and operate the sprayer to achieve even coverage throughout the crop canopy. Apply sufficient spray volume

to cover the crop to the point of run-off. Avoid excessive run-off.

The required spray volume to achieve point of run-off may be determined by applying different test volumes, using

different settings on the sprayer, or from industry guidelines or other expert advice.

Add the amount of product specified in the Directions for Use table for each 100 L of water. Spray to the point of run-

off.

The required dilute spray volume to achieve point of run-off will change and the sprayer set up and operation may

also need to be changed, as the crop grows.

Info

pest

Verified

Octave WP

Concentrate spraying

Use a sprayer designed and set up for concentrate spraying (that is a sprayer which applies spray volumes less than

those required to reach the point of run-off) and matched to the crop being sprayed.

Set up and operate the sprayer to achieve even coverage throughout the crop canopy using your chosen spray

volume.

Determine an appropriate dilute spray volume (See Dilute Spraying above) for the crop canopy. This is needed to

calculate the concentrate mixing rate.

The mixing rate for the concentrate spraying can then be calculated in the following way:

EXAMPLE ONLY

Dilute spray volume as determined above: For example 1500 L/ha

Your chosen concentrate spray volume: For example 500 L/ha

The concentration factor in this example is: 3 X (i.e. 1500 L

500 L = 3)

As the dilute label rate is 100 g/100 L, then the concentrate rate becomes 3 x 100, that is 300 g of product per

100 L water for concentrate spraying.

The chosen spray volume, amount of product per 100 L of water, and the sprayer set up and operation may need to

be changed as the crop grows.

Do not use a concentrate rate higher than 5 X.

For further information on concentrate spraying, users are advised to consult relevant industry guidelines, undertake

appropriate competency training and follow industry Best Practice.

Compatibility

The product is compatible with dimethoate, mancozeb, carbaryl WP, demeton-S-methyl, methomyl, fenbutatin oxide,

methiocarb and dicofol.

PRECAUTIONS

Re-entry Period

Do not allow entry into treated areas until the spray deposits have dried. When prior entry is necessary, wear cotton

overalls buttoned to the neck and wrist and elbow-length PVC gloves. Clothing must be laundered after each day’s

use.

For glasshouses and other confined areas, do not re-enter until spray deposits have dried and area has been

thoroughly ventilated.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND ENVIRONMENT

This product is toxic to fish. DO NOT contaminate streams, rivers or waterways with the chemical or used containers.

Clean up spillages promptly.

DRIFT WARNING

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

adjacent crops, crop lands, pastures or livestock.

STORAGE AND DISPOSAL

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

Single rinse before disposal. Add rinsings to spray tank. Do not dispose of undiluted chemicals on site. 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.

SAFETY DIRECTIONS

Product is poisonous if swallowed. Will irritate the eyes and skin. Avoid contact with eyes and skin. When opening the

container and preparing spray, wear elbow-length PVC gloves. 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.

After each day's use wash contaminated clothing and gloves.

FIRST AID

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

MATERIAL SAFETY DATA SHEET

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

www.bayercropscience.com.au.

EXCLUSION OF LIABILITY

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

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

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

Octave WP

Octave

is a Registered Trademark of Bayer

NRA Approval No.: 30485/0303

FOR 24 HOUR SPECIALIST ADVICE

IN EMERGENCY ONLY

PHONE 1800 033 111

DIRECTIONS FOR USE

Restraint

DO NOT allow the spray mix to stand overnight.

CROP

DISEASE

STATE

RATE

WHP

(days)

CRITICAL COMMENTS

Field grown

lettuce and

nursery stock

prior to

transplant-

ation

(closed head

varieties only)

Anthracnose

(Microdochium

panattonianum)

States

50 g/100 L

applied in

800 L water/ha

(ie. 400 g/ha applied

high volume)

Apply as a foliar spray on a 7 to 14 day

schedule. Use the shorter interval

when continual wet, cloudy conditions

favour disease development.

Mangoes

Anthracnose

blossom blight

(Colletotrichum

gloeosporioides

var. minor)

Qld,

NSW,

only

Dilute spraying:

100 g/100 L plus

200 g/100 L of an

800 g/kg formulation

of mancozeb.

Concentrate spraying:

Refer to the

Application section in

GENERAL

INSTRUCTIONS for

both Octave and

mancozeb rates.

-

Apply on a 3 to 4 week schedule

throughout the flowering period. Use

the shorter interval when weather

conditions favour disease

development.

Ensure thorough coverage of

blossoms.

Apply by dilute or concentrate spraying

equipment. Apply the same total

amount of product to the target crop

whether applying this product by dilute

or concentrate spraying methods.

For concentrate spraying do not apply

Octave at more than 500 g/100 L (i.e.

at a concentration factor greater than

5 X)

Mushrooms

Dry bubble

(Verticillium

fungicola var.

fungicola),

wet bubble

(Mycogone

perniciosa),

cobweb disease

(Hypomyces

rosellus)

States

24 g/0.3 m

of peat

OR

3 g/m

of casing

surface

Incorporation

Mix with the water used to wet the peat

and incorporate with the peat prior to

casing.

Spray application following harvest

of first flush

If Octave has not been incorporated in

the peat and disease becomes a

problem, spray the casing immediately

after harvest of first flush. Use

adequate water to thoroughly wet the

casing.

Proteas

Damping-off and

die-back

(Colletotrichum spp.)

States

(NOT

ACT or

300 g/100 L

Commence spraying in early Spring

and apply at 10 to 14 day intervals

depending on disease pressure. Use

the shorter interval when conditions

favour disease development. Spray

the entire plant using a sufficient

volume to ensure thorough coverage

(just before point of run-off).

Octave WP

CROP

DISEASE

STATE

RATE

WHP

(days)

CRITICAL COMMENTS

Strawberries -

Non-fruiting

strawberry

runners only

Colletotrichum

crown rot, stolon rot

(Colletotrichum

gloeosporioides)

Qld,

only

100 g/100 L

Apply as a foliar spray on a 7 to 14 day

schedule. Use the shorter interval

when continual wet, cloudy conditions

favour disease development. Ensure

thorough spray coverage on both (leaf)

surfaces and into the crown of the

plants.

Violas

Anthracnose

(Colletotrichum

violae-tricoloris),

spot anthracnose

(Sphaceloma violae)

States

300 g/100 L

Spray at 7 to 28 day intervals. Use the

shorter intervals when conditions

favour disease development.

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

UNDER APPROPRIATE LEGISLATION.

WITHHOLDING PERIOD (WHP)

Lettuce (closed head varieties) - DO NOT HARVEST WITHIN 7 DAYS OF APPLICATION.

Mangoes, mushrooms, proteas, strawberries - NOT REQUIRED WHEN USED AS DIRECTED.

Important Note - DO NOT FEED TREATED CROP TO LIVESTOCK, OR ALLOW LIVESTOCK TO GRAZE TREATED

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

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

Published on: Wed, 21 Nov 2018 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 Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

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

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

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

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

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

9-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems

FDA - U.S. Food and Drug Administration

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

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

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Opinion/decision on a Paediatric investigation plan (PIP): Clostridium Botulinum neurotoxin type A (150 kD), free from complexing proteins, decision type: , therapeutic area: , PIP number: P/0338/2018

Europe - EMA - European Medicines Agency

19-12-2018

EU/3/13/1169 (Richardson Associates Regulatory Affairs Ltd)

EU/3/13/1169 (Richardson Associates Regulatory Affairs Ltd)

EU/3/13/1169 (Active substance: Lipid-complexed cisplatin) - Transfer of orphan designation - Commission Decision (2018)9013 of Wed, 19 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000002651

Europe -DG Health and Food Safety

18-12-2018

EU/3/18/2111 (Rheacell GmbH and Co. KG)

EU/3/18/2111 (Rheacell GmbH and Co. KG)

EU/3/18/2111 (Active substance: Allogeneic ABCB5-positive limbal stem cells) - Orphan designation - Commission Decision (2018)9026 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/155/18

Europe -DG Health and Food Safety

26-11-2018

As device technology evolves and becomes increasingly complex, #FDA needs to keep pace. Our proposed changes to the 510(k) clearance pathway will allow FDA to retire outdated predicates and use new technologies to promote innovation and improved safety.

As device technology evolves and becomes increasingly complex, #FDA needs to keep pace. Our proposed changes to the 510(k) clearance pathway will allow FDA to retire outdated predicates and use new technologies to promote innovation and improved safety.

As device technology evolves and becomes increasingly complex, #FDA needs to keep pace. Our proposed changes to the 510(k) clearance pathway will allow FDA to retire outdated predicates and use new technologies to promote innovation and improved safety. https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

2-10-2018

Xigduo (AstraZeneca AB)

Xigduo (AstraZeneca AB)

Xigduo (Active substance: dapagliflozin/metformin) - Centralised - Renewal - Commission Decision (2018)6462 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2672/R/44

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