METHYL BROMIDE

Main information

  • Trade name:
  • NUFARM METHYL BROMIDE 1000 FUMIGANT
  • Pharmaceutical form:
  • LIQUID
  • Units in package:
  • 35kg,50kg,100kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical

Documents

Localization

  • Available in:
  • NUFARM METHYL BROMIDE 1000 FUMIGANT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BED - PLANT - QPS AND CUE TREATMENT | BUILDINGS & SIMILAR STRUCTURES QPS & CUE | CANE PRODUCTS QPS & APPROVED CUE | CEREAL GRAIN
  • Therapeutic area:
  • Group 8A Insecticide
  • Therapeutic indications:
  • BROWN ROT - SCLEROTINIA SPP. | CROWN ROT - VERTICILLIUM SPP. | DAMPING OFF - PYTHIUM ULTIMUM | DAMPING OFF - RHIZOCTONIA SPP. | DAMPING OFF FUNGI | FUSARIUM SPP. | INSECT | NEMATODE - SOIL BORNE PLANT PARASITIC | NUTGRASS | RODENT, RAT OR MOUSE | STORED PRODUCT INSECT PESTS | WEED SEED | BLACK RAT/MOUSE | BLOSSOM BLIGHT | BROWN RAT/MOUSE | FAT HEN | FUSARIUM PATCH | FUSARIUM SPP. | MOUSE | PRINCE OF WALES FEATHER | PYTHIUM SPP. | RAT | RHIZOCTONIA SPP. | RODENT | ROOF RAT | SOIL FUNGI | VICTORIAN NUTGRASS | WEED SEEDS | WINTER GRASS
  • Product summary:
  • For use by professional and registered fumigators for control of soil borne pests & diseases.For use by professional/registered fumigators in accordance with Quarantine & Pre-shipment (QPS) and Critical Use Exemption (CUE) protocol (refer label).

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 34067/0707
  • Authorization date:
  • 17-01-2008
  • Last update:
  • 15-06-2017

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

n A3

Nufarm

Methyl

Bromide

1000

Fumigant

ACTIVE CONSTITUENT: 1000 g/kg METHYL BROMIDE

For use by professional and registered

fumigators for control of soil borne

pests and diseases as specified in the

Directions for Use table.

Contents: 35 kg

TOXIC

GAS

2

OD12000 07/07

GROUP

INSECTICIDE

8 A

METHYL BROMIDE

UN. No. 1062

HAZCHEM: 2 X E

IN AN EMERGENCY DIAL: 000

POLICE OR FIRE BRIGADE

IN AN EMERGENCY,

SPECIALIST ADVICE

NUFARM AUSTRALIA LIMITED

1800 033 498

DANGEROUS POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

Manufactured by:

BROMIDE COMPOUNDS Ltd.

P.O Box 180,

Beer-Sheva 84101, ISRAEL

DIRECTION FOR USE - ALL STATES

RESTRAINTS

DO NOT treat soil if temperature at 10-15 cm depth is below 10˚C.

DO NOT treat soil when very cold, very wet or very dry.

DO NOT treat seeds intended for planting or sowing.

1. Soil Fumigation: If soil temperature is between 10-15˚C double the aeration and exposure times listed below.

GENERAL INSTRUCTIONS:

IMPORTANT

General: DO NOT fumigate more than once as the treated commodity could become unfit for use.

Fumigation and aeration should be performed in accordance with the appropriate Code of Practice for

fumigation using methyl bromide. Signs as below must be prominently shown at all approaches to

fumigation site.

DANGER - TOXIC GAS - KEEP AWAY

Station a guard at the treatment site to prevent entry of unauthorised persons, children and animals,

during treatment and aeration period.

After fumigation, aerate structures well, until an appropriate measuring device indicated fumigation area

free of Methyl Bromide.

DO NOT drop, bump or drag cans.

DO NOT unload by rope-sling, hooks or tongs.

Keep cans upright in tamper-proof airy stores, away from dwelling and food and feedstuffs.

Put out all pilot lights and glowing heating units.

Always wear full face respirator (with Methyl Bromide “O” type canister) complying with AS 1716 when

releasing gas and after fumigation when aerating the area.

Soil Fumigation: Plant growth has occasionally been unsatisfactory in soil treated with this product.

Difficulty has been experienced with carnations, conifers, holly, multiflora roses, snapdragons and other

ornamental plants and shrubs. Be sure treated soil or material is free from METHYL BROMIDE before

seeding or using. Working the soil will help aeration. Prevent contamination of fumigated areas.

If necessary to avoid flooding, trench around them or build wooden or earthen dams. Clean shoes

carefully when walking from untreated to treated soil. Do not use tools, transplants or crop remains that

may carry pests from unfumigated areas. Fumigation with METHYL BROMIDE may slow down

nitrification. Certain ammonia-sensitive plants such as tomatoes, may suffer growth inhibition or stand

reduction when placed in soil containing high ammonia-nitrogen. This hazard can be overcome by

delaying planting for several months or by the application of nitrate from nitrogenous fertilizers.

General Fumigation: Wear full-face respirator (with Methyl Bromide”O” type canister) complying with AS

1716 when releasing gas and when opening up structures for aeration. Use a halide detector for locating

gas leaks from cylinders and outside structures. Use detection tubes or other monitoring devices inside

structures. DO NOT enter fumigation areas until Methyl Bromide free as indicated by measuring devices.

If however treated area must be entered, a self-contained breathing suit or apparatus conforming to AS

1715 and AS 1716 MUST BE WORN.

INSECTICIDE RESISTANCE WARNING

For insecticide resistance management Nufarm Methyl Bromide 1000 Fumigant ‘Methyl Bromide 1000’ is

a group 8A insecticide. Some naturally occurring insect biotypes resistant to ‘Methyl Bromide 1000’ and

other Group 8A insecticides may exist through normal genetic variability in any insect population. The

resistant individuals can eventually dominate the insect population if ‘Methyl Bromide 1000’ and other

Group 8A insecticides are used repeatedly. The effectiveness of ‘Methyl Bromide 1000’ on resistant

individuals could be significantly reduced. Since occurrence of resistant individuals is difficult to detect

prior to use, Nufarm Australia Limited accepts no liability for any losses that may result from the failure of

‘Methyl Bromide 1000’ to control resistant insects. ‘Methyl Bromide 1000’ may be subject to specific

resistance management strategies. For further information contact your local supplier, Nufarm Australia

Limited representative or local agricultural department agronomist.

Warning: Methyl Bromide gas is colourless, odourless and highly dangerous. Extreme caution is required

when handling.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET PLANTS

Do NOT treat within 50cm of roots of desirable vegetation.

Do NOT apply to areas adjacent to valuable crops.

PROTECTION OF LIVESTOCK, WILDLIFE, FISH, CRUSTACEA AND ENVIRONMENT

Do not contaminate streams, rivers or waterways with the chemical or used containers.

STORAGE AND DISPOSAL

Store in a locked room or place away from children, animals, food, feedstuffs, seed and fertilizers. Store

in a well ventilated area, as cool as possible. Do not store for prolonged periods in direct sunlight. Empty

contents fully into application equipment. Close all valves and return to point of supply for refill or storage.

SAFETY DIRECTIONS

Very dangerous. Product is poisonous if inhaled. Attacks eyes. May irritate the nose, throat and skin.

Repeated minor exposure may have a cumulative poisoning effect. The liquid can cause burns. Avoid

contact with eyes and skin and clothing. Do not inhale vapour. Protect eyes while using. When using the

product wear full facepiece respirator with canister specified for methyl bromide. Detailed instructions for

safe use appear in state regulations. Thoroughly ventilate treated areas before reoccupying. If clothing

becomes contaminated with product remove clothing immediately. After use and before eating, drinking

or smoking, wash hands, arms and face thoroughly with soap and water. After each day’s use, wash

respirator and if rubber wash with detergent and warm water.

FIRST AID

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

contact occurs, remove contaminated clothing and wash skin thoroughly. Remove from contaminated

area. Apply artificial respiration if not breathing.

MATERIAL SAFETY DATA SHEET

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

CONDITIONS OF SALE

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

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

the foregoing, all warranties, conditions, rights and remedies, expressed or implied under common law, statute

or otherwise, in relation to the sale, supply, use or application of this product, are excluded. Nufarm Australia

Limited and/or its affiliates (“Nufarm”) shall not accept any liability whatsoever (including consequential loss), or

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

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

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

Critical Comments

Where possible, treat inside a fumigation chamber.

If not using a sealed pressure injection unit:

The area to be fumigated should be well cultivated and the soil/compost should be moist but not wet.

Make a furrow (150 mm deep) around the plot to be treated and lay tarpaulin, polythene or other plastic

sheeting over cover supports (e.g. inverted bottles or wire hoops), to enclose the material to be fumigated.

Ensure the sheeting edges are in the furrow.

Connect plastic hoses to cylinder.

Thoroughly seal edges of sheet in the furrow, by filling with soil and tramping down.

Connect applicator and turn on valve on the cylinder.

Refer to General Instructions section for more detailed instructions.

If using a sealed, pressure injection unit:

Thoroughly cultivate the soil and ensure it is kept in moist conditions for 5 to 7 days prior to treatment;

Apply methyl bromide to the soil by means of a sealed pressure injection unit, with tyne spacing of 30 cm

and at a depth of 15 - 20 cm;

To seal in fumigant, cover immediately behind tynes with plastic sheet and seal edges.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment, be

used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal

requirement in some states.

Mandatory recordkeeping

and reporting

requirements apply.

Situation

Plant beds, turf & other local areas:

QPS* and current approved CUE**

treatments ONLY.

Well-rotted compost, manure and

top soil: QPS* and current

approved CUE** treatments ONLY.

Mulching straw or hay: QPS* and

current approved CUE**

treatments ONLY.

Plant beds and other local areas:

QPS* and current approved CUE**

treatments ONLY.

Decomposed compost and

manure: QPS* and current

approved CUE** treatments ONLY.

Pests and weeds

controlled

Nematodes,

insects and weed

seeds.

For nutgrass

control, use double

dosage rate.

Damping off fungi

such as species of

Pythium,

Rhizoctonia and

Fusarium, and soil

borne fungi such

as sclerotinia and

verticillium causing

plant disease

Dosage

50 grams

per 1 square

metre

300 grams

per 1 cubic

metre

120 grams

per 1 bale

1 kg per 10

square

metres

600 grams

per cubic

metre

Minimum

exposure time

24 hours

24 hours

48 hours

24 hours

24 hours

Aeration time

before planting

48 hours

72 hours

24 hours

72 hours or

longer

72 hours or

longer

^ : 1 bale is approximately 20 - 30 kg

2. General Fumigation

Situation

General grains, cereal products,

dried fruits, pulse and pulse

products (including field peas),

timber and cane products, buildings

and other structures:

Quarantine and Pre-Shipment

(QPS*)

current approved Critical Use

Exemption (CUE**) treatments

ONLY.

Buildings & Similar structures:

Quarantine and Pre-Shipment (QPS*)

current approved Critical Use

Exemption (CUE**) treatments ONLY.

Pests

Controlled

Stored

product

insect pests

Rodents

Dosage

g/m

3

24-32

32-40

32-40

40-48

Temperature

(˚C)

Above 15

Between 10

and 15

Above 15

Between 10

and 15

Above 4

Exposure

Time

24 hours

24 hours

3 hours

3 hours

5 hours

Critical Comments

Under atmospheric pressure.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

Under sustained vacuum.

(10 - 16.7kPa absolute pressure). It is recommended that recapture technology to recapture methyl bromide at the end of the

treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

* QPS = Quarantine and Pre-shipment. The Ozone Protection and Synthetic Greenhouse Gas Management Regulations 1995 set out what are QPS uses.

Quarantine relates to fumigations performed by, or with the authorisation of, a Commonwealth, State or Territory authority to prevent the introduction, establishment or spread of a pest or disease in Australia, a State or a Territory.

Pre-shipment relates to fumigations carried out on a commodity, before it is exported, to meet the requirements of the importing country or a law of the Commonwealth.

**: CUE: Critical Use Exemption. This is an approved non-QPS

use of methyl bromide, granted by the Parties to the Montreal Protocol.

Exempt persons are listed on the Non-QPS Exemption List, posted on the Department of the Environment and Water Resources [DEW] website (www.environment.gov.au/atmosphere/ozone/publications/exemption-

list.html). Exempt persons must not use quantities of methyl bromide in excess of their allocated amount, specified on the Non-QPS Exemption List, and are only permitted to use methyl bromide for the purpose for

which the exemption was granted.

Approved CUEs must

be current in the year of methyl bromide use.

+: Methyl bromide is used for a Non-QPS application if it is used for an application that is not a QPS application and other than as a feedstock.

# : Record Keeping: Anyone who uses methyl bromide must keep a record of the details of every fumigation performed, for a period of five years, in an approved form. Inspectors appointed under the Ozone

Protection and Synthetic Greenhouse Gas Management Act 1989 may audit these records at any time.

## : Reporting: Exemption holders are required to report all use under their exemption, within 14 days of the end of each 6 month period staring January and July, to Department of the Environment and Water

Resources [DEW], in an approved form.

General Fumigants

Prevent leakage of fumigant, ensure that all windows, doors and other openings are sealed and the area is signposted. When fumigating buildings, grain trucks and ship holds, apply the fumigant from outside the

structure. After fumigation, aerate the structure well and keep animals, children and unauthorised persons away from the treatment area until free from Methyl Bromide as indicated by an appropriate measuring

device.

Refer to General Instructions section for more detailed instructions.

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

THIS PRODUCT IS TOO HAZARDOUS TO BE RECOMMENDED FOR USE IN THE HOME GARDEN.

THIS PRODUCT SHOULD BE AVAILABLE TO AUTHORISED OR LICENCED PERSONS FOR RESEARCH PURPOSES AND APPROVED INDUSTRIAL

AND MANUFACTURING PURPOSE ONLY.

WITHHOLDING PERIOD: DO NOT USE FUMIGATED COMMODITIES FOR HUMAN OR ANIMAL CONSUMPTION OR FOR FABRICATION INTO FOOD

FOR HUMAN OR ANIMAL CONSUMPTION WITHIN 3 DAYS OF COMPLETION OF FUMIGATION, OR UNTIL THE COMMODITY HAS BEEN

ADEQUATELY VENTILATED.

GROUP

INSECTICIDE

8 A

Dimensions: 485mm(w) x 307mm(h), PDF @ 80% on A3

APVMA Approval No.: 34067/35kg/0707

Batch No:

Date of Manufacture:

12000 Methyl Bromide 1000 35kg.qxd 20/9/07 11:26 AM Page 1

APPROVED

LABEL

Info

pest

Verified

Nufarm

Methyl

Bromide

1000

Fumigant

ACTIVE CONSTITUENT: 1000 g/kg METHYL BROMIDE

For use by professional and registered

fumigators for control of soil borne

pests and diseases as specified in the

Directions for Use table.

Contents: 50 kg

TOXIC

GAS

2

OD12000 07/07

GROUP

INSECTICIDE

8 A

METHYL BROMIDE

UN. No. 1062

HAZCHEM: 2 X E

IN AN EMERGENCY DIAL: 000

POLICE OR FIRE BRIGADE

IN AN EMERGENCY,

SPECIALIST ADVICE

NUFARM AUSTRALIA LIMITED

1800 033 498

DANGEROUS POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

Manufactured by:

BROMIDE COMPOUNDS Ltd.

P.O Box 180,

Beer-Sheva 84101, ISRAEL

DIRECTION FOR USE - ALL STATES

RESTRAINTS

DO NOT treat soil if temperature at 10-15 cm depth is below 10˚C.

DO NOT treat soil when very cold, very wet or very dry.

DO NOT treat seeds intended for planting or sowing.

1. Soil Fumigation: If soil temperature is between 10-15˚C double the aeration and exposure times listed below.

GENERAL INSTRUCTIONS:

IMPORTANT

General: DO NOT fumigate more than once as the treated commodity could become unfit for use.

Fumigation and aeration should be performed in accordance with the appropriate Code of Practice for

fumigation using methyl bromide. Signs as below must be prominently shown at all approaches to

fumigation site.

DANGER - TOXIC GAS - KEEP AWAY

Station a guard at the treatment site to prevent entry of unauthorised persons, children and animals,

during treatment and aeration period.

After fumigation, aerate structures well, until an appropriate measuring device indicated fumigation area

free of Methyl Bromide.

DO NOT drop, bump or drag cans.

DO NOT unload by rope-sling, hooks or tongs.

Keep cans upright in tamper-proof airy stores, away from dwelling and food and feedstuffs.

Put out all pilot lights and glowing heating units.

Always wear full face respirator (with Methyl Bromide “O” type canister) complying with AS 1716 when

releasing gas and after fumigation when aerating the area.

Soil Fumigation: Plant growth has occasionally been unsatisfactory in soil treated with this product.

Difficulty has been experienced with carnations, conifers, holly, multiflora roses, snapdragons and other

ornamental plants and shrubs. Be sure treated soil or material is free from METHYL BROMIDE before

seeding or using. Working the soil will help aeration. Prevent contamination of fumigated areas.

If necessary to avoid flooding, trench around them or build wooden or earthen dams. Clean shoes

carefully when walking from untreated to treated soil. Do not use tools, transplants or crop remains that

may carry pests from unfumigated areas. Fumigation with METHYL BROMIDE may slow down

nitrification. Certain ammonia-sensitive plants such as tomatoes, may suffer growth inhibition or stand

reduction when placed in soil containing high ammonia-nitrogen. This hazard can be overcome by

delaying planting for several months or by the application of nitrate from nitrogenous fertilizers.

General Fumigation: Wear full-face respirator (with Methyl Bromide”O” type canister) complying with AS

1716 when releasing gas and when opening up structures for aeration. Use a halide detector for locating

gas leaks from cylinders and outside structures. Use detection tubes or other monitoring devices inside

structures. DO NOT enter fumigation areas until Methyl Bromide free as indicated by measuring devices.

If however treated area must be entered, a self-contained breathing suit or apparatus conforming to AS

1715 and AS 1716 MUST BE WORN.

INSECTICIDE RESISTANCE WARNING

For insecticide resistance management Nufarm Methyl Bromide 1000 Fumigant ‘Methyl Bromide 1000’ is

a group 8A insecticide. Some naturally occurring insect biotypes resistant to ‘Methyl Bromide 1000’ and

other Group 8A insecticides may exist through normal genetic variability in any insect population. The

resistant individuals can eventually dominate the insect population if ‘Methyl Bromide 1000’ and other

Group 8A insecticides are used repeatedly. The effectiveness of ‘Methyl Bromide 1000’ on resistant

individuals could be significantly reduced. Since occurrence of resistant individuals is difficult to detect

prior to use, Nufarm Australia Limited accepts no liability for any losses that may result from the failure of

‘Methyl Bromide 1000’ to control resistant insects. ‘Methyl Bromide 1000’ may be subject to specific

resistance management strategies. For further information contact your local supplier, Nufarm Australia

Limited representative or local agricultural department agronomist.

Warning: Methyl Bromide gas is colourless, odourless and highly dangerous. Extreme caution is required

when handling.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET PLANTS

Do NOT treat within 50cm of roots of desirable vegetation.

Do NOT apply to areas adjacent to valuable crops.

PROTECTION OF LIVESTOCK, WILDLIFE, FISH, CRUSTACEA AND ENVIRONMENT

Do not contaminate streams, rivers or waterways with the chemical or used containers.

STORAGE AND DISPOSAL

Store in a locked room or place away from children, animals, food, feedstuffs, seed and fertilizers. Store

in a well ventilated area, as cool as possible. Do not store for prolonged periods in direct sunlight. Empty

contents fully into application equipment. Close all valves and return to point of supply for refill or storage.

SAFETY DIRECTIONS

Very dangerous. Product is poisonous if inhaled. Attacks eyes. May irritate the nose, throat and skin.

Repeated minor exposure may have a cumulative poisoning effect. The liquid can cause burns. Avoid

contact with eyes and skin and clothing. Do not inhale vapour. Protect eyes while using. When using the

product wear full facepiece respirator with canister specified for methyl bromide. Detailed instructions for

safe use appear in state regulations. Thoroughly ventilate treated areas before reoccupying. If clothing

becomes contaminated with product remove clothing immediately. After use and before eating, drinking

or smoking, wash hands, arms and face thoroughly with soap and water. After each day’s use, wash

respirator and if rubber wash with detergent and warm water.

FIRST AID

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

contact occurs, remove contaminated clothing and wash skin thoroughly. Remove from contaminated

area. Apply artificial respiration if not breathing.

MATERIAL SAFETY DATA SHEET

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

CONDITIONS OF SALE

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

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

the foregoing, all warranties, conditions, rights and remedies, expressed or implied under common law, statute

or otherwise, in relation to the sale, supply, use or application of this product, are excluded. Nufarm Australia

Limited and/or its affiliates (“Nufarm”) shall not accept any liability whatsoever (including consequential loss), or

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

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

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

Critical Comments

Where possible, treat inside a fumigation chamber.

If not using a sealed pressure injection unit:

The area to be fumigated should be well cultivated and the soil/compost should be moist but not wet.

Make a furrow (150 mm deep) around the plot to be treated and lay tarpaulin, polythene or other plastic

sheeting over cover supports (e.g. inverted bottles or wire hoops), to enclose the material to be fumigated.

Ensure the sheeting edges are in the furrow.

Connect plastic hoses to cylinder.

Thoroughly seal edges of sheet in the furrow, by filling with soil and tramping down.

Connect applicator and turn on valve on the cylinder.

Refer to General Instructions section for more detailed instructions.

If using a sealed, pressure injection unit:

Thoroughly cultivate the soil and ensure it is kept in moist conditions for 5 to 7 days prior to treatment;

Apply methyl bromide to the soil by means of a sealed pressure injection unit, with tyne spacing of 30 cm

and at a depth of 15 - 20 cm;

To seal in fumigant, cover immediately behind tynes with plastic sheet and seal edges.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment, be

used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal

requirement in some states.

Mandatory recordkeeping

and reporting

requirements apply.

Situation

Plant beds, turf & other local areas:

QPS* and current approved CUE**

treatments ONLY.

Well-rotted compost, manure and

top soil: QPS* and current

approved CUE** treatments ONLY.

Mulching straw or hay: QPS* and

current approved CUE**

treatments ONLY.

Plant beds and other local areas:

QPS* and current approved CUE**

treatments ONLY.

Decomposed compost and

manure: QPS* and current

approved CUE** treatments ONLY.

Pests and weeds

controlled

Nematodes,

insects and weed

seeds.

For nutgrass

control, use double

dosage rate.

Damping off fungi

such as species of

Pythium,

Rhizoctonia and

Fusarium, and soil

borne fungi such

as sclerotinia and

verticillium causing

plant disease

Dosage

50 grams

per 1 square

metre

300 grams

per 1 cubic

metre

120 grams

per 1 bale

1 kg per 10

square

metres

600 grams

per cubic

metre

Minimum

exposure time

24 hours

24 hours

48 hours

24 hours

24 hours

Aeration time

before planting

48 hours

72 hours

24 hours

72 hours or

longer

72 hours or

longer

^ : 1 bale is approximately 20 - 30 kg

2. General Fumigation

Situation

General grains, cereal products,

dried fruits, pulse and pulse

products (including field peas),

timber and cane products, buildings

and other structures:

Quarantine and Pre-Shipment

(QPS*)

current approved Critical Use

Exemption (CUE**) treatments

ONLY.

Buildings & Similar structures:

Quarantine and Pre-Shipment (QPS*)

current approved Critical Use

Exemption (CUE**) treatments ONLY.

Pests

Controlled

Stored

product

insect pests

Rodents

Dosage

g/m

3

24-32

32-40

32-40

40-48

Temperature

(˚C)

Above 15

Between 10

and 15

Above 15

Between 10

and 15

Above 4

Exposure

Time

24 hours

24 hours

3 hours

3 hours

5 hours

Critical Comments

Under atmospheric pressure.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

Under sustained vacuum.

(10 - 16.7kPa absolute pressure). It is recommended that recapture technology to recapture methyl bromide at the end of the

treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

* QPS = Quarantine and Pre-shipment. The Ozone Protection and Synthetic Greenhouse Gas Management Regulations 1995 set out what are QPS uses.

Quarantine relates to fumigations performed by, or with the authorisation of, a Commonwealth, State or Territory authority to prevent the introduction, establishment or spread of a pest or disease in Australia, a State or a Territory.

Pre-shipment relates to fumigations carried out on a commodity, before it is exported, to meet the requirements of the importing country or a law of the Commonwealth.

**: CUE: Critical Use Exemption. This is an approved non-QPS

use of methyl bromide, granted by the Parties to the Montreal Protocol.

Exempt persons are listed on the Non-QPS Exemption List, posted on the Department of the Environment and Water Resources [DEW] website (www.environment.gov.au/atmosphere/ozone/publications/exemption-

list.html). Exempt persons must not use quantities of methyl bromide in excess of their allocated amount, specified on the Non-QPS Exemption List, and are only permitted to use methyl bromide for the purpose for

which the exemption was granted.

Approved CUEs must

be current in the year of methyl bromide use.

+: Methyl bromide is used for a Non-QPS application if it is used for an application that is not a QPS application and other than as a feedstock.

# : Record Keeping: Anyone who uses methyl bromide must keep a record of the details of every fumigation performed, for a period of five years, in an approved form. Inspectors appointed under the Ozone

Protection and Synthetic Greenhouse Gas Management Act 1989 may audit these records at any time.

## : Reporting: Exemption holders are required to report all use under their exemption, within 14 days of the end of each 6 month period staring January and July, to Department of the Environment and Water

Resources [DEW], in an approved form.

General Fumigants

Prevent leakage of fumigant, ensure that all windows, doors and other openings are sealed and the area is signposted. When fumigating buildings, grain trucks and ship holds, apply the fumigant from outside the

structure. After fumigation, aerate the structure well and keep animals, children and unauthorised persons away from the treatment area until free from Methyl Bromide as indicated by an appropriate measuring

device.

Refer to General Instructions section for more detailed instructions.

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

THIS PRODUCT IS TOO HAZARDOUS TO BE RECOMMENDED FOR USE IN THE HOME GARDEN.

THIS PRODUCT SHOULD BE AVAILABLE TO AUTHORISED OR LICENCED PERSONS FOR RESEARCH PURPOSES AND APPROVED INDUSTRIAL

AND MANUFACTURING PURPOSE ONLY.

WITHHOLDING PERIOD: DO NOT USE FUMIGATED COMMODITIES FOR HUMAN OR ANIMAL CONSUMPTION OR FOR FABRICATION INTO FOOD

FOR HUMAN OR ANIMAL CONSUMPTION WITHIN 3 DAYS OF COMPLETION OF FUMIGATION, OR UNTIL THE COMMODITY HAS BEEN

ADEQUATELY VENTILATED.

GROUP

INSECTICIDE

8 A

Dimensions: 485mm(w) x 307mm(h), PDF @ 80% on A3

APVMA Approval No.: 34067/50kg/0707

Batch No:

Date of Manufacture:

12000 Methyl Bromide 1000 50kg.qxd 20/9/07 11:27 AM Page 1

APPROVED

LABEL

Nufarm

Methyl

Bromide

1000

Fumigant

ACTIVE CONSTITUENT: 1000 g/kg METHYL BROMIDE

For use by professional and registered

fumigators for control of soil borne

pests and diseases as specified in the

Directions for Use table.

Contents: 100 kg

TOXIC

GAS

2

OD12000 07/07

GROUP

INSECTICIDE

8 A

METHYL BROMIDE

UN. No. 1062

HAZCHEM: 2 X E

IN AN EMERGENCY DIAL: 000

POLICE OR FIRE BRIGADE

IN AN EMERGENCY,

SPECIALIST ADVICE

NUFARM AUSTRALIA LIMITED

1800 033 498

DANGEROUS POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Nufarm Australia Limited

ACN 004 377 780

103-105 Pipe Road

Laverton North Victoria 3026

Tel: (03) 9282 1000

Fax: (03) 9282 1001

Manufactured by:

BROMIDE COMPOUNDS Ltd.

P.O Box 180,

Beer-Sheva 84101, ISRAEL

DIRECTION FOR USE - ALL STATES

RESTRAINTS

DO NOT treat soil if temperature at 10-15 cm depth is below 10˚C.

DO NOT treat soil when very cold, very wet or very dry.

DO NOT treat seeds intended for planting or sowing.

1. Soil Fumigation: If soil temperature is between 10-15˚C double the aeration and exposure times listed below.

GENERAL INSTRUCTIONS:

IMPORTANT

General: DO NOT fumigate more than once as the treated commodity could become unfit for use.

Fumigation and aeration should be performed in accordance with the appropriate Code of Practice for

fumigation using methyl bromide. Signs as below must be prominently shown at all approaches to

fumigation site.

DANGER - TOXIC GAS - KEEP AWAY

Station a guard at the treatment site to prevent entry of unauthorised persons, children and animals,

during treatment and aeration period.

After fumigation, aerate structures well, until an appropriate measuring device indicated fumigation area

free of Methyl Bromide.

DO NOT drop, bump or drag cans.

DO NOT unload by rope-sling, hooks or tongs.

Keep cans upright in tamper-proof airy stores, away from dwelling and food and feedstuffs.

Put out all pilot lights and glowing heating units.

Always wear full face respirator (with Methyl Bromide “O” type canister) complying with AS 1716 when

releasing gas and after fumigation when aerating the area.

Soil Fumigation: Plant growth has occasionally been unsatisfactory in soil treated with this product.

Difficulty has been experienced with carnations, conifers, holly, multiflora roses, snapdragons and other

ornamental plants and shrubs. Be sure treated soil or material is free from METHYL BROMIDE before

seeding or using. Working the soil will help aeration. Prevent contamination of fumigated areas.

If necessary to avoid flooding, trench around them or build wooden or earthen dams. Clean shoes

carefully when walking from untreated to treated soil. Do not use tools, transplants or crop remains that

may carry pests from unfumigated areas. Fumigation with METHYL BROMIDE may slow down

nitrification. Certain ammonia-sensitive plants such as tomatoes, may suffer growth inhibition or stand

reduction when placed in soil containing high ammonia-nitrogen. This hazard can be overcome by

delaying planting for several months or by the application of nitrate from nitrogenous fertilizers.

General Fumigation: Wear full-face respirator (with Methyl Bromide”O” type canister) complying with AS

1716 when releasing gas and when opening up structures for aeration. Use a halide detector for locating

gas leaks from cylinders and outside structures. Use detection tubes or other monitoring devices inside

structures. DO NOT enter fumigation areas until Methyl Bromide free as indicated by measuring devices.

If however treated area must be entered, a self-contained breathing suit or apparatus conforming to AS

1715 and AS 1716 MUST BE WORN.

INSECTICIDE RESISTANCE WARNING

For insecticide resistance management Nufarm Methyl Bromide 1000 Fumigant ‘Methyl Bromide 1000’ is

a group 8A insecticide. Some naturally occurring insect biotypes resistant to ‘Methyl Bromide 1000’ and

other Group 8A insecticides may exist through normal genetic variability in any insect population. The

resistant individuals can eventually dominate the insect population if ‘Methyl Bromide 1000’ and other

Group 8A insecticides are used repeatedly. The effectiveness of ‘Methyl Bromide 1000’ on resistant

individuals could be significantly reduced. Since occurrence of resistant individuals is difficult to detect

prior to use, Nufarm Australia Limited accepts no liability for any losses that may result from the failure of

‘Methyl Bromide 1000’ to control resistant insects. ‘Methyl Bromide 1000’ may be subject to specific

resistance management strategies. For further information contact your local supplier, Nufarm Australia

Limited representative or local agricultural department agronomist.

Warning: Methyl Bromide gas is colourless, odourless and highly dangerous. Extreme caution is required

when handling.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET PLANTS

Do NOT treat within 50cm of roots of desirable vegetation.

Do NOT apply to areas adjacent to valuable crops.

PROTECTION OF LIVESTOCK, WILDLIFE, FISH, CRUSTACEA AND ENVIRONMENT

Do not contaminate streams, rivers or waterways with the chemical or used containers.

STORAGE AND DISPOSAL

Store in a locked room or place away from children, animals, food, feedstuffs, seed and fertilizers. Store

in a well ventilated area, as cool as possible. Do not store for prolonged periods in direct sunlight. Empty

contents fully into application equipment. Close all valves and return to point of supply for refill or storage.

SAFETY DIRECTIONS

Very dangerous. Product is poisonous if inhaled. Attacks eyes. May irritate the nose, throat and skin.

Repeated minor exposure may have a cumulative poisoning effect. The liquid can cause burns. Avoid

contact with eyes and skin and clothing. Do not inhale vapour. Protect eyes while using. When using the

product wear full facepiece respirator with canister specified for methyl bromide. Detailed instructions for

safe use appear in state regulations. Thoroughly ventilate treated areas before reoccupying. If clothing

becomes contaminated with product remove clothing immediately. After use and before eating, drinking

or smoking, wash hands, arms and face thoroughly with soap and water. After each day’s use, wash

respirator and if rubber wash with detergent and warm water.

FIRST AID

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

contact occurs, remove contaminated clothing and wash skin thoroughly. Remove from contaminated

area. Apply artificial respiration if not breathing.

MATERIAL SAFETY DATA SHEET

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

CONDITIONS OF SALE

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

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

the foregoing, all warranties, conditions, rights and remedies, expressed or implied under common law, statute

or otherwise, in relation to the sale, supply, use or application of this product, are excluded. Nufarm Australia

Limited and/or its affiliates (“Nufarm”) shall not accept any liability whatsoever (including consequential loss), or

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

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

In case of emergency: Phone 1800 033 498

Ask for shift supervisor. Toll free 24 hours.

Critical Comments

Where possible, treat inside a fumigation chamber.

If not using a sealed pressure injection unit:

The area to be fumigated should be well cultivated and the soil/compost should be moist but not wet.

Make a furrow (150 mm deep) around the plot to be treated and lay tarpaulin, polythene or other plastic

sheeting over cover supports (e.g. inverted bottles or wire hoops), to enclose the material to be fumigated.

Ensure the sheeting edges are in the furrow.

Connect plastic hoses to cylinder.

Thoroughly seal edges of sheet in the furrow, by filling with soil and tramping down.

Connect applicator and turn on valve on the cylinder.

Refer to General Instructions section for more detailed instructions.

If using a sealed, pressure injection unit:

Thoroughly cultivate the soil and ensure it is kept in moist conditions for 5 to 7 days prior to treatment;

Apply methyl bromide to the soil by means of a sealed pressure injection unit, with tyne spacing of 30 cm

and at a depth of 15 - 20 cm;

To seal in fumigant, cover immediately behind tynes with plastic sheet and seal edges.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment, be

used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal

requirement in some states.

Mandatory recordkeeping

and reporting

requirements apply.

Situation

Plant beds, turf & other local areas:

QPS* and current approved CUE**

treatments ONLY.

Well-rotted compost, manure and

top soil: QPS* and current

approved CUE** treatments ONLY.

Mulching straw or hay: QPS* and

current approved CUE**

treatments ONLY.

Plant beds and other local areas:

QPS* and current approved CUE**

treatments ONLY.

Decomposed compost and

manure: QPS* and current

approved CUE** treatments ONLY.

Pests and weeds

controlled

Nematodes,

insects and weed

seeds.

For nutgrass

control, use double

dosage rate.

Damping off fungi

such as species of

Pythium,

Rhizoctonia and

Fusarium, and soil

borne fungi such

as sclerotinia and

verticillium causing

plant disease

Dosage

50 grams

per 1 square

metre

300 grams

per 1 cubic

metre

120 grams

per 1 bale

1 kg per 10

square

metres

600 grams

per cubic

metre

Minimum

exposure time

24 hours

24 hours

48 hours

24 hours

24 hours

Aeration time

before planting

48 hours

72 hours

24 hours

72 hours or

longer

72 hours or

longer

^ : 1 bale is approximately 20 - 30 kg

2. General Fumigation

Situation

General grains, cereal products,

dried fruits, pulse and pulse

products (including field peas),

timber and cane products, buildings

and other structures:

Quarantine and Pre-Shipment

(QPS*)

current approved Critical Use

Exemption (CUE**) treatments

ONLY.

Buildings & Similar structures:

Quarantine and Pre-Shipment (QPS*)

current approved Critical Use

Exemption (CUE**) treatments ONLY.

Pests

Controlled

Stored

product

insect pests

Rodents

Dosage

g/m

3

24-32

32-40

32-40

40-48

Temperature

(˚C)

Above 15

Between 10

and 15

Above 15

Between 10

and 15

Above 4

Exposure

Time

24 hours

24 hours

3 hours

3 hours

5 hours

Critical Comments

Under atmospheric pressure.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

Under sustained vacuum.

(10 - 16.7kPa absolute pressure). It is recommended that recapture technology to recapture methyl bromide at the end of the

treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

It is recommended that recapture technology to recapture methyl bromide at the end of the treatment be used where appropriate.

Note that recapture of methyl bromide at the end of the treatment, for re-use or destruction, may be a legal requirement in

some states.

Mandatory recordkeeping

and reporting

requirements apply.

* QPS = Quarantine and Pre-shipment. The Ozone Protection and Synthetic Greenhouse Gas Management Regulations 1995 set out what are QPS uses.

Quarantine relates to fumigations performed by, or with the authorisation of, a Commonwealth, State or Territory authority to prevent the introduction, establishment or spread of a pest or disease in Australia, a State or a Territory.

Pre-shipment relates to fumigations carried out on a commodity, before it is exported, to meet the requirements of the importing country or a law of the Commonwealth.

**: CUE: Critical Use Exemption. This is an approved non-QPS

use of methyl bromide, granted by the Parties to the Montreal Protocol.

Exempt persons are listed on the Non-QPS Exemption List, posted on the Department of the Environment and Water Resources [DEW] website (www.environment.gov.au/atmosphere/ozone/publications/exemption-

list.html). Exempt persons must not use quantities of methyl bromide in excess of their allocated amount, specified on the Non-QPS Exemption List, and are only permitted to use methyl bromide for the purpose for

which the exemption was granted.

Approved CUEs must

be current in the year of methyl bromide use.

+: Methyl bromide is used for a Non-QPS application if it is used for an application that is not a QPS application and other than as a feedstock.

# : Record Keeping: Anyone who uses methyl bromide must keep a record of the details of every fumigation performed, for a period of five years, in an approved form. Inspectors appointed under the Ozone

Protection and Synthetic Greenhouse Gas Management Act 1989 may audit these records at any time.

## : Reporting: Exemption holders are required to report all use under their exemption, within 14 days of the end of each 6 month period staring January and July, to Department of the Environment and Water

Resources [DEW], in an approved form.

General Fumigants

Prevent leakage of fumigant, ensure that all windows, doors and other openings are sealed and the area is signposted. When fumigating buildings, grain trucks and ship holds, apply the fumigant from outside the

structure. After fumigation, aerate the structure well and keep animals, children and unauthorised persons away from the treatment area until free from Methyl Bromide as indicated by an appropriate measuring

device.

Refer to General Instructions section for more detailed instructions.

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

THIS PRODUCT IS TOO HAZARDOUS TO BE RECOMMENDED FOR USE IN THE HOME GARDEN.

THIS PRODUCT SHOULD BE AVAILABLE TO AUTHORISED OR LICENCED PERSONS FOR RESEARCH PURPOSES AND APPROVED INDUSTRIAL

AND MANUFACTURING PURPOSE ONLY.

WITHHOLDING PERIOD: DO NOT USE FUMIGATED COMMODITIES FOR HUMAN OR ANIMAL CONSUMPTION OR FOR FABRICATION INTO FOOD

FOR HUMAN OR ANIMAL CONSUMPTION WITHIN 3 DAYS OF COMPLETION OF FUMIGATION, OR UNTIL THE COMMODITY HAS BEEN

ADEQUATELY VENTILATED.

GROUP

INSECTICIDE

8 A

Dimensions: 485mm(w) x 307mm(h), PDF @ 80% on A3

APVMA Approval No.: 34067/100kg/0707

Batch No:

Date of Manufacture:

12000 Methyl Bromide 1000 100kg.qxd 20/9/07 11:25 AM Page 1

APPROVED

LABEL

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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

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

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

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

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

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

11-1-2019


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

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

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

Europe - EMA - European Medicines Agency

11-1-2019


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

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

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

Europe - EMA - European Medicines Agency

20-12-2018

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (AstraZeneca AB)

Bevespi Aerosphere (Active substance: glycopyrronium bromide / formoterol) - New authorisation - Commission Decision (2018)9127 of Thu, 20 Dec 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4245

Europe -DG Health and Food Safety

20-12-2018


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

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

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

Europe - EMA - European Medicines Agency

19-12-2018


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

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

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

Europe - EMA - European Medicines Agency

14-12-2018


Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide,  13/12/2018,  Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Summary of opinion: Trimbow,beclometasone / formoterol / glycopyrronium bromide, 13/12/2018, Positive

Europe - EMA - European Medicines Agency

11-12-2018


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

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

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

Europe - EMA - European Medicines Agency

7-12-2018


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

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

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

Europe - EMA - European Medicines Agency

28-11-2018

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Glaxo Group Ltd)

Anoro Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)8049 of Wed, 28 Nov 2018

Europe -DG Health and Food Safety

22-11-2018


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

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

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

Europe - EMA - European Medicines Agency

22-11-2018

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (GlaxoSmithKline (Ireland) Limited)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7876 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2809/T/22

Europe -DG Health and Food Safety

22-11-2018

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

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

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

Europe -DG Health and Food Safety

16-11-2018

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Glaxo Group Ltd)

Incruse Ellipta (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)7676 of Fri, 16 Nov 2018

Europe -DG Health and Food Safety

16-11-2018

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (GlaxoSmithKline (Ireland) Limited)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7673 of Fri, 16 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3754/T/26

Europe -DG Health and Food Safety

14-11-2018

Laventair Ellipta (Glaxo Group Ltd)

Laventair Ellipta (Glaxo Group Ltd)

Laventair Ellipta (Active substance: umeclidinium bromide / vilanterol trifenatate) - Centralised - Yearly update - Commission Decision (2018)7611 of Wed, 14 Nov 2018

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

30-10-2018

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

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

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

Europe -DG Health and Food Safety

22-10-2018

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

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

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

Europe -DG Health and Food Safety

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

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

Europe -DG Health and Food Safety