GASTION - TABLETS

Main information

  • Trade name:
  • RENTOKIL GASTION PHOSPHINE FUMIGATION TABLETS
  • Pharmaceutical form:
  • TABLET (INC. PELLET, BOLUS, SUPPOSITORY, CAPSULE)
  • Units in package:
  • 300g (100 Tabs), 1.5kg (500 Tabs)
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • RENTOKIL INITIAL

Documents

Localization

  • Available in:
  • RENTOKIL GASTION PHOSPHINE FUMIGATION TABLETS
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • GRAIN STORAGE AREA AND/OR FACILITY | STORED BARLEY SEED | STORED BREAKFAST CEREAL | STORED BULK STOCK FEED | STORED CEREAL GRAIN
  • Therapeutic area:
  • Group 24A Insecticide
  • Therapeutic indications:
  • ANGOUMOIS GRAIN MOTH | BEAN WEEVIL | CADELLE | CIGARETTE BEETLE | COCKROACH | COFFEE BEAN WEEVIL | CONFUSED FLOUR BEETLE | DRIED FRUIT BEETLE | FLAT GRAIN BEETLE | GRANARY WEEVIL | HIDE OR SKIN BEETLE | INDIAN MEAL MOTH | LESSER GRAIN BORER | MAIZE WEEVIL | MEDITERRANEAN FLOUR MOTH | MERCHANT GRAIN BEETLE | MOTTLED GRAIN MOTH | MOUSE - MUS SPP. | PSOCIDS OR BOOKLOUSE | RAISIN MOTH | RAT | REDLEGGED HAM BEETLE | RICE WEEVIL | RUST-RED FLOUR BEETLE | SAWTOOTHED GRAIN BEETLE | SPIDER BEETLE | STORED PRODUCT MITE | TOBACCO MOTH | TROPICAL WAREHOUSE MOTH | WAREHOUSE BEETLE | DERMESTES ATER | DERMESTES MACULATUS | GRAIN BORER | LARGE COCKROACH | SMALL COCKROACH | TOBACCO BEETLE
  • Product summary:
  • For the control of insect pests of stored products in certain situations.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 32071/0209
  • Authorization date:
  • 27-08-2009
  • Last update:
  • 15-06-2017

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

DANGEROUS POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE

OPENING OR USING

ACTIVE CONSTITUENT: 330 g/kg PHOSPHINE (PH

3

) present as

ALUMINIUM PHOSPHIDE

Each 3 g tablet liberates 0.99 g PHOSPHINE (PH

3

)

GROUP

INSECTICIDE

8B

For control of insect pests of stored products in certain situations

and rabbits as per the Directions for Use Table

Important: Read the attached leaflet before use.

Manufactured by: BEQUISA - S. Vicente - Sao Paulo - BRAZIL

Whose trademark is GASTION

Distributed in Australia by:

RENTOKIL INITIAL Pty Ltd

A.C.N. 000 034 597

Unit A1, Lidcombe Business Park,

3-29 Birnie Ave, Lidcombe NSW 2141 Australia

Phone 02 8719 6265

1300 RENTOKIL www.rentokil.com.au

APVMA Approval No. 32071/1.5kg/0209

NET CONTENTS: 1.5 kg

(500 tablets)

SAFETY DIRECTIONS:

Very dangerous. Product

releases dangerous phosphine gas slowly in moist air and

immediately if wet. Can kill if inhaled or swallowed.

DO NOT inhale dust or vapour. Avoid contact with eyes

and skin. Open container in the open air. Keep away from

water and liquids. Keep away from naked flames. Forms

toxic gas. Use entire contents in one operation; if not

possible, seal container thoroughly with waterproof

adhesive tape or air-tight enclosure. Wash hands after use.

When opening the container and using the product wear

elbow-length PVC gloves and full face piece respirator with

combined dust and gas cartridge (canister) or supplied air

respirator. After each day’s use wash gloves and respirator

(if rubber wash with detergent and warm water).

FIRST AID:

If poisoning occurs, contact a doctor or

Poisons Information Centre. Phone Australia 131126.

Do not give direct mouth-to-mouth resuscitation if

swallowed. To protect rescuer, use air-viva, oxy-viva or

one-way mask. Resuscitate in a well ventilated area.

UN 1397 ALUMINIUM PHOSPHIDE

IN A TRANSPORT EMERGENCY

DIAL 000 POLICE OR FIRE BRIGADE

GASTION

PHOSPHINE FUMIGATION TAblETS

Batch Number

Date of Manufacture

31643 RPC Gastion tablets label 1.5kg v4.indd 1

14/7/09 5:03:23 PM

32071_46380_1.5kg_immediate_MPL_V02 23/7/2009 65 x 143 mm A4, A3 100%

APPROVED

LABEL

Info

pest

Verified

DANGEROUS POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE

OPENING OR USING

ACTIVE CONSTITUENT: 330 g/kg PHOSPHINE (PH

3

) present as

ALUMINIUM PHOSPHIDE

Each 3 g tablet liberates 0.99 g PHOSPHINE (PH

3

)

GROUP

INSECTICIDE

8B

NET CONTENTS: 300 g

(100 tablets)

SAFETY DIRECTIONS:

Very dangerous. Product releases

dangerous phosphine gas slowly in moist air and immediately

if wet. Can kill if inhaled or swallowed. DO NOT inhale dust

or vapour. Avoid contact with eyes and skin. Open container

in the open air. Keep away from water and liquids. Keep away

from naked flames. Forms toxic gas. Use entire contents in

one operation; if not possible, seal container thoroughly with

waterproof adhesive tape or air-tight enclosure. Wash hands

after use. When opening the container and using the product

wear elbow-length PVC gloves and full face piece respirator

with combined dust and gas cartridge (canister) or supplied air

respirator. After each day’s use wash gloves and respirator

(if rubber wash with detergent and warm water).

FIRST AID:

If poisoning occurs, contact a doctor or Poisons

Information Centre. Phone Australia 131126. Do not give direct

mouth-to-mouth resuscitation if swallowed. To protect rescuer,

use air-viva, oxy-viva or one-way mask. Resuscitate in a well

ventilated area.

UN 1397 ALUMINIUM PHOSPHIDE

IN A TRANSPORT EMERGENCY

DIAL 000 POLICE OR FIRE BRIGADE

GASTION

PHOSPHINE FUMIGATION TAblETS

Batch Number

Date of Manufacture

For control of insect pests of stored products in certain situations

and rabbits as per the Directions for Use Table

Important: Read the attached leaflet before use.

Manufactured by: BEQUISA - S. Vicente - Sao Paulo - BRAZIL

Whose trademark is GASTION

Distributed in Australia by:

RENTOKIL INITIAL Pty Ltd

A.C.N. 000 034 597

Unit A1, Lidcombe Business Park,

3-29 Birnie Ave, Lidcombe NSW 2141 Australia

Phone 02 8719 6265

1300 RENTOKIL www.rentokil.com.au

APVMA Approval No. 32071/300g/0209

32071_46380_300g_immediate_MPL_V02 23/7/2009 65 x 135 mm A4, A3 100%

APPROVED

LABEL

DANGEROUS POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

ACTIVE CONSTITUENT: 330 g/kg PHOSPHINE (PH

3

)

present as ALUMINIUM PHOSPHIDE

Each 3 g tablet liberates 0.99 g PHOSPHINE (PH

3

)

Important: Read this leafl et before use.

GROUP

INSECTICIDE

8B

Application of Rentokil Gastion Phosphine Fumigation Tablets in unsealed

storages/ enclosures and use of low dose rates and shortened exposure

periods is contrary to label instruction and will contribute to development

of resistance.

FLAMMABLE: Keep away from naked fl ame.

PRECAUTIONS:

Show the following warning sign prominently at all approaches to every

fumigation site.

“DANGER – POISON GAS — KEEP AWAY”

Keep animals, children and unauthorised persons away from the area under

treatment until the area is shown to be free from phosphine as indicated by

a gas measuring device.

WARNING: Containers must be opened in the open air. Whilst opening

containers take care and point containers away from the face and body, as

under certain conditions possible build-up of gas may result in fl ash fl ame

upon exposure to air.

DO NOT confi ne the product in small gas-proof enclosures such as a plastic

bag. Such confi nement could cause the gas concentrations to reach the

lower fl ammability level, and may result in fi re or explosion.

Application rates higher than label directions and contrary to label

instruction could cause the gas concentrations to reach the lower

fl ammability level which is 1.79% by volume (17,900 parts per million).

When used according to the label directions, the amount of gas produced

remains far below the lower fl ammability level.

RE-ENTRY PERIODS:

After application, wait until the Exposure Period has passed, then

thoroughly ventilate for the required Ventilation Period and to the

required Standard. Re-entry to fumigation areas is not recommended

until measuring device(s) indicate that they are free of phosphine. The use

of gas detection tubes or other measuring devices is recommended for

monitoring gas levels in fumigation areas as phosphine gas may still be

present even after treated commodities have been removed and fumigation

areas ventilated.

DO NOT re-enter a storage after application has commenced or once

treated grain/commodity has been emptied without wearing a full face

respirator with particulate (P1) and phosphine gas fi lter cartridge (canister)

or self-contained breathing apparatus, until a measuring device indicates

that it is free of phosphine or the Total fumigation period (minimum

exposure period plus ventilation period) has elapsed.

PROTECTION OF LIVESTOCK:

Disturbance of unreacted phosphide powder residue results in release of

more phosphine gas. Residues of phosphine gas or unreacted phosphide

powder in treated grain/commodity will be harmful if fed to animals,

including poultry. Ensure feed is well mixed and that such residues are

not present before feeding. DO NOT feed treated grain/commodity to

animals, including poultry, until the Total Fumigation Period (Exposure plus

Ventilation) plus the Withholding Period has expired.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND

ENVIRONMENT:

This product is highly toxic to wildlife. Dangerous to fi sh. DO NOT

contaminate streams, rivers or waterways with the chemical or used

containers.

STORAGE AND DISPOSAL:

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

area, out of the reach of children and unauthorised persons and away from

all dwellings, animals, food, feedstuffs, seed and fertilisers.

DO NOT store or carry container in vehicle cabins (this includes glove

compartments, luggage compartments or other common air-spaces).

Keep away from water and liquids. Water and many liquids cause

immediate release of phosphine from the product. Uncontrolled release

of phosphine may result in fi re or explosion and release of gas will pose a

serious risk of injury to workers and bystanders.

After fumigation with the product on trays/sheets remove the spent

tablets and ensure residual phosphide is destroyed before disposal, e.g. by

swamping with dilute acid or soapy water in open air until bubbling ceases.

Dispose of deactivated residues below 500 mm in an approved disposal

pit specifi cally marked and set up for this purpose, clear of waterways,

desirable vegetation and tree roots.

Triple rinse the empty containers with soapy water to ensure residual

phosphide is destroyed. Dispose of rinsings in an approved disposal pit.

Destroy empty containers by breaking, crushing or puncturing them.

Dispose of the containers at a local authority landfi ll. If no local authority

landfi ll is available, bury the containers below 500 mm in an approved

disposal pit. DO NOT burn empty containers or product.

SAFETY DIRECTIONS:

Dangerous. Product releases dangerous phosphine gas slowly in moist air

and immediately if wet. Can kill if inhaled or swallowed. DO NOT inhale

dust or vapour. Avoid contact with eyes and skin. Open container in the

open air. Keep away from water and liquids. Keep away from naked fl ames.

Forms toxic gas. Use entire contents in one operation; if not possible, seal

container thoroughly with waterproof adhesive tape or air-tight closure.

Wash hands after use. When opening the container or using the product

wear elbow length PVC gloves and full face piece respirator with combined

dust and gas cartridge (canister) or supplied air respirator. After each days

use wash gloves and respirator (if rubber wash with detergent and warm

water).

FIRST AID:

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

Australia 131126. Do not give direct mouth-to-mouth resuscitation if

swallowed. To protect rescuer, use air-viva, oxy-viva or one-way mask.

Resuscitate in a well-ventilated area.

MSDS: Additional information is listed in the Material Safety Data Sheet.

MANUFACTURER’S WARRANTY AND EXCLUSION OF LIABILITY:

This product as supplied is of a high grade and believed to be suitable for

any purpose for which it is expressly recommended and must be used in

accordance with the Directions for Use given on the label. No responsibility

is accepted in respect of this product save those non-excludable conditions

implied by any Federal or State legislation or law of a Territory.

GASTION

PHOSPHINE FUMIGATION TABLETS

For control of insect pests of stored products in

certain situations and rabbits as per the Directions for Use Table

APVMA Approval No. 32071/0209

Manufactured by:

BEQUISA - S. Vicente - Sao Paulo - BRAZIL

Whose trademark is GASTION

Distributed in Australia by:

RENTOKIL INITIAL Pty Ltd

A.C.N. 000 034 597

Unit A1, Lidcombe Business Park,

3-29 Birnie Ave, Lidcombe NSW 2141 Australia

Telephone 02 8719 6265

a Rentokil Initial company

UN 1397 ALUMINIUM

PHOSPHIDE

IN A TRANSPORT EMERGENCY

DIAL 000 POLICE OR FIRE BRIGADE

SAFETY DIRECTIONS:

Very dangerous. Product releases dangerous phosphine gas slowly in moist air and immediately if wet.

Can kill if inhaled or swallowed. DO NOT inhale dust or vapour. Avoid contact with eyes and skin. Open

container in the open air. Keep away from water and liquids. Keep away from naked fl ames. Forms toxic

gas. Use entire contents in one operation; if not possible, seal container thoroughly with waterproof

adhesive tape or air-tight closure. Wash hands after use. When opening the container or using the product

wear elbow length PVC gloves and full face piece respirator with combined dust and gas cartridge

(canister) or supplied air respirator. After each days use wash gloves and respirator (if rubber wash with

detergent and warm water).

FIRST AID:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126. Do not give

direct mouth-to-mouth resuscitation if swallowed. To protect rescuer, use air-viva, oxy-viva or one-way

mask. Resuscitate in a well-ventilated area.

FUMIGATION SERVICE

If your situation requires professional advice or service, call 1300 RENTOKIL (1300 7368 6545)

or visit www.rentokil.com.au

32071_xxxxx_leaflet_PPL_V01 13/7/2010 417 x 150 mm A4 69%, A3 98%

DIRECTIONS FOR USE:

BEFORE using Rentokil Gastion Phosphine Fumigation Tablets you should

consider the following:

Timing of treatment –If it will be necessary to move grain/commodity

before the Total Fumigation Period has expired, then fumigation should

NOT be commenced. Movement of treated commodities or empty

containers during application, fumigation exposure or ventilation risks

exposure of transport and handling workers and the public to harmful

levels of phosphine and is contrary to label instruction.

The Total Fumigation Period is the sum of the time required for Exposure

to phosphine and the time needed to ventilate the grain. A shortened

Exposure Period will not be effective for storage pest control and a reduced

Ventilation Period poses a serious risk of phosphine gas poisoning to

workers and bystanders. In addition a Withholding Period of two days is

required after completion of ventilation before the grain is allowed to be

used for human consumption or for animal feed. See Notes 4 & 5 for a

detailed description of the Minimum Exposure Period and the Ventilation

Period.

Safety and handling of Phosphine Products – Phosphine is a highly

dangerous fumigant and fumigation should only be undertaken in

situations where the safety of workers and the public can be ensured.

Observe all RESTRAINTS, PRECAUTIONS and instructions on the label.

1. FUMIGATION OF STORAGE PESTS

RESTRAINTS:

DO NOT fumigate in inhabited buildings.

DO NOT fumigate in work situations where there is a risk that phosphine

gas could leak from fumigation enclosures into working areas.

DO NOT use on commodities, or in empty containers, railcars or vessels

that are in transit or likely to be in transit during the Exposure and/or

Ventilation periods.

DO NOT use in road transport vehicles (including a truck or road hauled

container).

DO NOT heap tablets. Heaped tablets limit gas release.

DO NOT add water to the Tablets.

DO NOT use when commodity temperature is less than 15°C or the relative

humidity within the structure is less than 25% or with raw cereal grains

when the moisture content is less than 9%.

DO NOT apply in structures that are not well sealed*.

DO NOT apply as a surface-only treatment in a structure whose height

exceeds twice its width, unless the structure/enclosure has a gas

recirculation device fitted.

NOTES

1) FUMIGATION WILL CONTROL ALL STAGES OF INSECTS ONLY IN

STRUCTURES/ENCLOSURES THAT ARE WELL SEALED*. Well sealed

structures/enclosures are fumigation chambers, well sealed silos, sheds

and buildings, and other fumigation enclosures made gas-tight with gas-

proof sheeting. Well sealed means permanent sealing of porous surfaces,

seams and cracks and temporary sealing of intake and/or outlet valves,

doors, fan housings, windows and hatches. For further information see

appropriate industry advisory documents such as Grains Research and

Development Corporation ‘Advice’ sheet ‘$ealed $ilos $ave’, available

from State Departments of Agriculture or Primary Industries. Increasing

the application rate will not compensate for gas loss from an

unsealed enclosure.

NOTE: STRUCTURES MUST BE WELL SEALED. IF THEY ARE NOT,

FUMIGATION WILL NOT GIVE ADEQUATE CONTROL, AND WOULD BE

CONTRARY TO LABEL DIRECTIONS.

2) STORAGE PESTS include: lesser grain borer, cadelle, cigarette beetle,

confused flour beetle, dried fruit beetle, flat grain beetle, merchant

grain beetle, red-legged ham beetle, rust-red flour beetle, sawtoothed

grain beetle, skin and hide beetle, spider beetles, warehouse beetle,

Angoumois grain moth, Indian meal moth, Mediterranean flour moth,

mottled grain moth, raisin moth, tobacco moth, tropical warehouse

moth, psocids, stored products mites, bean weevil, coffee bean

weevil, granary weevil, maize weevil, pea weevil and rice weevil. Such

treatment doses will also kill any cockroaches, rats and mice present.

3) PHOSPHINE APPLICATION RATES are based on the internal volume of

the structures to be fumigated; they apply equally to full or partly filled

or empty structures and they apply to all commodities. The commodity

equivalent rates (g/tonne) should only be used when the commodity

stowage factor is known, they apply only when the storage structures

are full or nearly full or when part-filled structures are dosed

on the tonnage equivalents of their internal volumes. The calculated

commodity equivalent dosage must be based on the rate per volume.

The application rate of 1.5 g phosphine per 1 metre

is equivalent to:

Capacity of fumigation enclosure

Number of Tablets

Tonnes wheat

Bushels

Cubic metres

13.2

16.5

26.4

52.8

1936

105.6

3872

9680

19360

1000

4) MINIMUM EXPOSURE PERIODS are needed to allow products to react

to completion and to expose insects for long enough to kill all stages.

A SHORTENED EXPOSURE PERIOD CANNOT BE COMPENSATED FOR BY

INCREASED DOSAGE. Insect death and reaction of the tablets are both

slower at lower temperatures. Temperatures specified are those within

the commodity to be fumigated. The minimum exposure period should

start from time of completion of application of product.

5) VENTILATION PERIOD – ON COMPLETION OF EXPOSURE

PERIOD: Ventilation of structures is complete only when phosphine

concentrations measured at appropriate locations in the enclosure and

work area are below the Threshold Limit Value - Time Weighted Average

(TLV - TWA) exposure standard of 0.3 ppm. The following are minimum

ventilation periods required and may need to be increased to ensure the

exposure standard is not exceeded.

Minimum Ventilation Periods:

Structures, including bunker storages, containing treated

commodities:

a) Without throughflow (i.e. access only through the headspace): not less

than 5 days

b) With throughflow and natural draught (wind): For structures of 300

tonnes or greater capacity: 2 to 5 days depending on size. For structures

of less than 300 tonnes capacity: 2 days.

c) With throughflow and forced draught (flash-proof fan) operated 2 hours

on and 2 hours off: not less than 1 day.

Tobacco: In bales: not less than two days. In cases and hogsheads: not less

than 3 days.

Empty Buildings and Enclosures:

a) Without throughflow: 5 days

b) With throughflow and natural draught (wind): For structures of 300

tonnes or greater capacity: not less than 2 days, depending on structure

size, openings and prevailing wind speed. For structures of less than 300

tonnes capacity: 2 days.

c) With throughflow and forced draught (flash-proof fan) operated 2 hours

on and 2 hours off: 1 to 2 days depending on size of structure.

2) FUMIGATION OF RABBIT BURROWS

(NSW, VIC, QLD, SA, WA, ACT only)

Situation

Rate

Critical comments

Burrow

1 or 2 tablets

per lead

(0.99 g or 1.98

g phosphine

per lead)

Cut back around hole to expose other leads or tunnels for treatment

and to provide adequate depth for the soil plug to close the opening

after treatment. Place tablets well down the tunnel to avoid

accidental covering by the soil plug. Fill the opening with ample

soil and firm down well. Leave the surface as level as possible to

discourage attention from outside rabbits. Effectiveness will be

increased in any soil condition if tablets are wrapped in moistened

paper prior to insertion in the hole. Best results from fumigation will

be achieved if the area to be treated is ‘dogged’ thoroughly before

the operation starts, to ensure that all rabbits are in their warrens.

NOT TO BE USED FOR ANY PURPOSE, OR IN ANY MANNER,

CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER

APPROPRIATE LEGISLATION.

WITHHOLDING PERIOD: DO NOT USE TREATED PRODUCT FOR

HUMAN CONSUMPTION OR FOR STOCK FOOD FOR 2 DAYS AFTER

COMPLETION OF FUMIGATION (MINIMUM EXPOSURE PERIOD PLUS

VENTILATION PERIOD).

TOBACCO: NOT REQUIRED WHEN USED AS DIRECTED.

TREATED COMMODITIES MAY BE SHIPPED AFTER COMPLETION OF

THE MINIMUM EXPOSURE PERIOD PLUS VENTILATION PERIOD.

GENERAL INSTRUCTIONS:

Rentokil Gastion Phosphine Fumigation Tablets release phosphine gas

when exposed to air. Phosphine penetrates through the commodity to kill

eggs, larvae, pupae and adult stages of storage pests in sealed enclosures,

but some eggs, pupae and adults will survive in unsealed enclosures (see

Note 1 above).

Protect by sealing or otherwise, sensitive electrical and electronic

equipment (computers, meters, switches, fire alarm system etc.) containing

copper/copper alloy components, photographic film or copy paper.

Phosphine corrodes copper based materials.

Application

Fumigation of Commodities in Silos and Bulk Storages:

Place the tablets in a single layer and separated from the commodity e.g.:-

on non-flammable trays/sheets which are evenly spread on the commodity

surface inside the storage.

Fumigation of Commodities under Gas Proof Sheeting:

Place tablets spaced from each other on non-flammable sheets/trays evenly

distributed between and/or alongside stacked commodities in a manner

that allows free circulation of gas. Ensure that the sheeting is sealed in a

gas-tight manner after application.

Fumigation of empty storages/enclosures:

Place tablets spaced from each other on non-flammable sheets/trays evenly

spread in the enclosure; with application starting at the furthest point from

the exit door. Ensure the enclosure is made gas-tight. Lock and seal exit

door after application.

INSECTICIDE RESISTANCE WARNING:

GROUP

INSECTICIDE

8B

For insecticide resistance management Rentokil Gastion Phosphine

Fumigation Tablets are a group 8B insecticide.

Some naturally occurring insect biotypes resistant to Rentokil Gastion

Phosphine Fumigation Tablets and other Group 8B insecticides may exist

through normal genetic variability in any insect population. The resistant

individuals can eventually dominate the insect population if Rentokil

Gastion Phosphine Fumigation Tablets or other Group 8B insecticides

are used repeatedly. The effectiveness of Rentokil Gastion Phosphine

Fumigation Tablets on resistant individuals could be significantly reduced.

Since occurrence of resistant individuals is difficult to detect prior to use,

Rentokil Initial Pty Ltd accepts no liability for any losses that may result

from the failure of Rentokil Gastion Phosphine Fumigation Tablets to

control resistant insects.

PESTS/ COMMODITY/

SITUATION

See Note 1 for description of well

sealed* and Note 2 for storage

pests controlled

APPLICATION

(see note 3)

FUMIGATION PERIOD#

#[TOTAL OF THE MINIMUM EXPOSURE

PERIOD PLUS VENTILATION PERIOD]

WITHHOLDING

PERIOD

TOTAL OF

(Exposure+

Ventilation+

Withholding)

BASIC RATE

(g

phosphine

per m

3

)

DOSAGE

(number

of tablets

per m

3

)

MINIMUM

EXPOSURE PERIOD

See Note 4

VENTILATION

PERIOD

See Note 5

Storage pests in:

Well-sealed* structures such as:-

Fumigation enclosures, grain storage

sheds, silos, and structures which are

suitable for fumigation;

Raw cereal grains (such as barley,

maize, millets, oats, rice, rye,

sorghum, triticale, wheat); Other food

commodities (such as flour and other

milled cereal products, breakfast

cereals, dried fruits, dried vegetables,

dried pulses, other dried foods, peanuts,

oilseeds, cocoa and coffee beans);

Seeds for propagation;

Bulk stockfeeds

3 tablets

per 2m

7 days when commodity

temperature is above 25°C

1-5 Days

2 Days

10-14 Days

10 days when commodity

temperature is 15°C

to 25°C

13-17 Days

20 days for surface

only application to bulk

commodities in well

sealed* structures greater

than 375 m

capacity (e.g.

greater than 300 tonnes

wheat)

23-27 Days

Tobacco in bales, cases, hogsheads in

well sealed* fumigation enclosures

7 days

2-3 Days

9-10 Days

Well-sealed* empty warehouses,

elevators, stores, structures and

enclosures.

7 days when temperature

is above 25°C

1-5 Days

8-12 Days

10 days when temperature

is 15°C to 25°C

11-15 Days

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Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

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

Europe - EFSA - European Food Safety Authority EFSA Journal

14-1-2019

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

Germany Black Ant 2000mg tablets (Zhansheng Weige Chaoyue Xilishi)

These tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

12-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. 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 distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

3-1-2019

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA.

FDA - U.S. Food and Drug Administration

1-1-2019

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 80 Lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP, Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classifi...

FDA - U.S. Food and Drug Administration

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

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

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinog...

FDA - U.S. Food and Drug Administration

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

11-12-2018

THAN YOU tablets

THAN YOU tablets

THAN YOU tablets pose a serious risk to your health and should not be taken.

Therapeutic Goods Administration - Australia

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

1-12-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Trichoderma reesei (strain DP‐Nzd22)

Published on: Fri, 30 Nov 2018 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP‐Nzd22) by DuPont. 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 endo‐1,4‐β‐xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of dis...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA - U.S. Food and Drug Administration

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

23-11-2018

ACT-Candesartan 4mg tablets (2018-11-23)

ACT-Candesartan 4mg tablets (2018-11-23)

Health Canada

22-11-2018

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

Foreign Product Alert: Black Ant King tablets, Gold Viagra 9800mg capsules, LIPRO Dietary capsules, Stree Overlord Strong tablets (pills), Vegetal Vigra capsules, ViaGro 500mg Male Enhancement capsules

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients.

Health Canada

22-11-2018

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

FDA approves new treatment for patients with acute myeloid leukemia

FDA approves new treatment for patients with acute myeloid leukemia

The FDA approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

FDA - U.S. Food and Drug Administration

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

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

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

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

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

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

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

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

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

29-10-2018

Big Penis U.S.A tablets

Big Penis U.S.A tablets

Big Penis U.S.A tablets pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

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

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

8-10-2018

Glyceryl trinitrate tablets (Anginine and Lycinate)

Glyceryl trinitrate tablets (Anginine and Lycinate)

Update 3 - continuing medicine shortage

Therapeutic Goods Administration - Australia

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

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

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

18-12-2018

APO-Valsartan (valsartan) tablets

APO-Valsartan (valsartan) tablets

Recall - potential contamination

Therapeutic Goods Administration - Australia