BASAMID

Main information

  • Trade name:
  • BASAMID GRANULAR SOIL FUMIGANT
  • Pharmaceutical form:
  • Granular
  • Units in package:
  • 20kg, 600kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • KANESHO SOIL TREATME

Documents

Localization

  • Available in:
  • BASAMID GRANULAR SOIL FUMIGANT
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BULK POTTING SOIL | FIELD OR BROADACRE | PRE-PLANTING SOIL TREATMENT | SEEDBED | BULK SOIL
  • Therapeutic area:
  • soil fumigant
  • Therapeutic indications:
  • ARMILLARIA SPP. | BLACK STEM CANKER SCURF | CLUB ROOT | CYST NEMATODE | DAMPING OFF - RHIZOCTONIA SPP. | FUSARIUM ROOTROT WILT | FUSARIUM SOIL FUNGUS | NON CYST-FORMING NEMATODE | PHYTOPHTHORA ROOT ROT | RHIZOCTONIA SOIL FUNGUS | ROOT ROT | SCLEROTINIA ROT | SCLEROTIUM STEM ROT | SEED ROOTROT | SOIL INSECT | SOIL-INHABITING FUNGUS | VERTICILLIUM WILT | WEED SEED - SEE LABEL | WILT ROOTROT OR DAMPING OFF | WILTING | BLACK SCURF | CANKER | DAMPING OFF | DAMPING-OFF | FAT HEN | HYPOCOTYL ROT | PRINCE OF WALES FEATHER | PYTHIUM ROOT ROT | PYTHIUM SOIL FUNGUS | ROOT ROT | SCLEROTINIA FLOWER BLIGHT | SCLEROTINIA FUNGAL DISEASE | SCLEROTINIA ROOT ROT | SCLEROTINIA SOIL FUNGUS | SEEDLING ROOT ROT | SOIL FUNGI | SUBCLOVER ROOTROT | VERTICILLIUM DAHLIAE | VERTICILLIUM SOIL FUNGUS | WEED SEEDS | WHITE MOULD | WILT - SCLEROTINIA | WINTER GRASS | WIRE STEM
  • Product summary:
  • For the control of nematodes, soil inhabiting insects, soil fungi and germinating seeds of weeds.Do NOT use when soil temperature exceeds 32oC. Do NOT apply to dry soil.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 34036/1206
  • Authorization date:
  • 03-04-2007
  • Last update:
  • 15-06-2017

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

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Granular Soil Fumigant

ACTIVE CONSTITUENT: 940 g/kg DAZOMET

For the control of nematodes, soil inhabiting insects, soil fungi and

germinating seeds of weeds as per the DIRECTIONS FOR USE table.

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

WITHHOLDING PERIOD: NOT REQUIRED WHEN USED AS DIRECTED.

Certis Australia Pty Ltd

24 De Little Circuit

Greenway, ACT 2900

Telephone: 0417 770 958

Batch No.:

Date of Manufacture:

THIS PRODUCT IS NOT CONSIDERED

TO BE A DANGEROUS GOOD UNDER THE

AUSTRALIAN CODE FOR THE TRANSPORT OF

DANGEROUS GOODS BY ROAD AND RAIL.

FOR 24 HOUR SPECIALIST ADVICE IN

EMERGENCY ONLY

PHONE – 0417 770 958

® = Registered trademarks of Kanesho Soil Treatment

BVBA, Belgium.

CODE EAN

DIRECTIONS FOR USE

RESTRAINTS: Do NOT use when soil temperature exceeds 32°C

Do NOT apply to dry soil

PEST

RATE

DEPTH OF

INCORPORATION

METHOD OF APPLICA

TION

SITUATION

Germinating seeds of weeds

or 350 kg/ha

(Increase rate by 17

for each 10 cm

extra depth)

60 to 70 g/m

or 600

to 700 kg/ha

(Increase rate

by 17 g/m

for each

10 cm extra depth

150 to 220 g/m

50 g/m

or 500 kg/ha

(Increase rate by

17 g/m

for each 10

cm extra depth)

10 to 15 cm

30 cm

1. Break up soil to the depth of fumigation 5 to 7 days before applying granules,

removing plant residues and undecomposed roots.

2. Ensure soil is moist for the 5 to 7 days before application of granules. Irrigate

if necessary.

3. Cultivate soil to a fine tilth.

4. Spread granules evenly over surface at the recommended rates.

5. Incorporate thoroughly immediately to recommended depth.

6. Seal surface by covering with plastic sheets, or by irrigating with 20 L

water/m

to form a surface crust, or by rolling.

7. Aerate soils where possible by:

a) piercing holes into plastic sheeting where it is to remain covering the soil,

b) removing plastic, and cultivating to a depth slightly less than that to which

the granules were incorporated.

8. Conduct a germination test 2 to 6 weeks after aeration to ensure no gas

residues remain. Once gases have escaped, planting or sowing may take

place. Details of the Germination Test are in General Instructions.

Note: Do NOT plant into soil until a positive Germination Test has been conducted.

1. Ensure soil is moist 5 to 7 days before application.

2. Mix granules thoroughly at recommended rates. Use soil blending equipment

or treat soil with BASAMID in 10 cm layers mixing with hoe or a fork. Treat

additional layers on top of layers already treated, to form one heap of treated

soil.

3. Seal soil with plastic sheets or store soil in sealed bins.

4. Aerate soil 5 to 7 days after treatment. If soil is not to be used within 6 weeks

of treatment aeration may not be necessary.

5. Wait 2 to 4 weeks after aeration to allow gases to escape before considering

planting.

6. Before planting, conduct a germination test to ensure all gas residues have

escaped before using soil.

Note: Do NOT plant into soil until a positive Germination Test has been conducted.

CRITICAL COMMENTS

Organic matter such as plant roots may delay decomposition of

BASAMID.

Moisture is essential for BASAMID to decompose into gases that kill pests.

Lumpy soil prevents even distribution of gases.

Spreading granules assists even distribution across the soil profile.

Thorough incorporation of granules ensures even distribution of

fumigating gases. Optimum results are obtained using plastic sheeting.

Without plastic sheeting, a reduction in the level of control can be

expected. Where soil temperatures are greater than 20°C or soils are of a

light sandy type that do not crust, plastic sheeting should be used to seal

the soil.

Usually aeration can take place 5 to 7 days after incorporation.

If soil temperature falls below 10°C, wait 14 days. On heavy soils or in

cold weather, extra cultivation may be necessary to aerate the soil

adequately.

Gas residues will cause crop damage. Wait 2 to 3 weeks before

conducting germination test if soil temperature is around 20°C.

Wait 3 to 6 weeks if soil temperature is around 10°C (See Germination

Test under General Instructions).

Moisture is essential for BASAMID to decompose into gases that kill

pests. Thorough mixing is essential for even distribution of fumigating

gases. If soil is dry, water may be added while mixing.

It is essential to prevent gases escaping to enable them time to take

effect.

If soil temperature falls below 10°C wait 14 days before aerating.

Re-mixing of the soil will help aerate the soil. Gas residues will cause

crop damage. (See Germination Test under General Instructions).

20 to 23 cm

Seed beds,

broadacre

Bulk soil

Soil fungi including: Pythium, Phyto-

phthora, Sclerotinia, Sclerotium,

Rhizoctonia, Verticillium, Plasmodio-

phora Armillaria and Fusarium spp.

causing root rot and wilt, clubroot,

and damping off of ornamentals,

vegetables and seedling plants. Soil

insects and non-cyst forming

nematodes.

Germinating seeds of weeds. Soil

fungi including: Pythium,

Phytophthora, Sclerotinia, Sclerotium,

Rhizoctonia, Verticillium,

Plasmodiophora, Armillaria and

Fusarium spp.

causing root rot and wilt, clubroot,

and damping off of ornamentals,

vegetables and seedling plants. Soil

insects and non-cyst forming

nematodes.

Cyst forming nematodes soilfungi and

other pests below 23 cm

GENERAL INSTRUCTIONS

MODE OF ACTION

When the granules come in contact with warm, moist soil,

they release gases. These gases kill actively respiring

nematodes, fungi, insects and weeds, but must be kept

sealed in the soil long enough to complete the fumigating

process. After these gases have sterilised the soil, they must

be completely dissipated before the crop can be planted.

APPLICATION

1. Granules may be spread by gloved hand or with an accurate

drop spreader to moist soil.

2. Incorporate preferably with a rotary hoe or with a hand

hoe.

3. Seal soil surface, preferably with plastic sheeting.

4. Use clean implements to aerate soil to avoid contamination.

5. Do NOT enter glasshouses for 7 days after application

unless wearing personal protective equipment specified

for applicators with goggles and a half face respirator with

organic vapour/gas cartridge.

6. Conduct a successful Germination Test before planting.

PRECAUTIONS

Workers previously experiencing skin or respiratory tract

irritation from dazomet or metham-sodium exposure should

not work with DAZOMET PRODUCTS. Workers performing

manual water-sealing and plastic sealing should wear the

personal protective clothing specified for applicators plus a

respirator with organic vapour/gas cartridge and goggles.

RE-ENTRY PERIOD

Field Uses: Do NOT allow entry into treated areas for 48

hours after application. When prior entry is necessary, wear

personal protective equipment specified for applicators.

Clothing must be laundered after each day's use.

Greenhouse Application, Including Under Plastic:

Do NOT allow entry into treated areas for 7 days after

application. When prior entry is necessary, wear personal

protective equipment specified for applicators with goggles

and a half face respirator with organic vapour/gas cartridge.

Clothing must be laundered after each day's use. Thoroughly

ventilate greenhouses for 24 hours after removing plastic.

RE-HANDLING PERIOD

Potting soil: Treated soil is to remain covered by plastic

sheeting or similar material impermeable to MITC (the active

gas produced by dazomet), for 7 days after treatment. When

prior handling is necessary, wear personal protective

equipment specified for applicators with goggles and a half

face respirator with organic vapour/gas cartridge. Clothing

must be laundered after each day's use.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET

PLANTS

Do NOT sow or plant until Germination Test indicates soil is

free of fumigating gases. Do NOT apply within 60 to 90 cm

of plants or of the root zone of trees or shrubs. If slopes are

treated take precautions that the chemical is not washed

down to growing plants. If using BASAMID in a confined area

(eg. glasshouses), no growing plants should be within that

area, or share the same air supply. If soils contain a high

proportion of organic matter (eg. plant residues, peat, moss,

etc.), the residues of BASAMID may take longer than normal

to disappear. To ensure that conditions are suitable to plant,

apply the Germination Test.

GERMINATION TEST

To ensure that the soil is free from BASAMID gases and

planting can begin, it is essential that a Germination Test is

made on the treated soil.

1. At several places in the treated area, scrape the surface

soil aside and quickly place a sample of soil in a jar. Do

NOT take soil from below the depth of incorporation. When

the jar is three-quarters full it should be immediately

sealed.

2. Three-quarters fill a second jar with untreated soil and

replace the lid.

3. Put cress or lettuce seeds on moist cotton pads or moist

filter paper and place in jars. Immediately replace the

sealing lids.

4. Place the jars in a room with a temperature around 20°C.

5. After 48 hours, check whether the seeds have germinated.

If the seeds have germinated in the jar with the untreated

soil but not in the jar with the treated soil, the toxic gases

have not yet escaped and the soil should be worked again

for aeration.

6. If the seeds with the treated soil germinate normally the

soil is clear and planting can proceed.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND

ENVIRONMENT

Do NOT contaminate streams, rivers and waterways with

product or used container.

STORAGE AND DISPOSAL

Store in the closed, original container in a cool, well-ventilated

area. Do NOT store for prolonged periods in direct sunlight.

Shake container empty onto treated area. Destroy empty

containers by breaking, crushing or puncturing them. Dispose

of the containers at a local authority landfill readily available

in your area, or bury the containers at a depth of 500 mm or

more at a licensed/ approved disposal site. In some States

wastes can only be buried at a licensed landfill. Do NOT burn

empty containers or product.

SAFETY DIRECTIONS

Product is poisonous if swallowed. Will irritate the eyes, nose,

throat and skin. Avoid contact with eyes and skin. Do NOT

inhale dust. The fumes first cause smarting, then watering

of eyes. This should be taken as a warning sign. When

opening the container and using the product wear cotton

overalls buttoned to the neck and wrist (or equivalent

clothing), a washable hat, elbow length (nitrile, neoprene)

gloves and chemical resistant footwear. If product on skin,

immediately wash area with soap and water. After use and

before eating, drinking or smoking, wash hands, arms and

face thoroughly with soap and water. After each day's use,

wash gloves and contaminated clothing. Do NOT re-use

footwear until thoroughly aired.

FIRST AID INSTRUCTIONS

If poisoning occurs, contact a doctor or Poisons Information

Centre. Telephone 131126 Australia-wide.

MATERIAL SAFETY DATA SHEET

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 and State

legislation or law of a Territory.

20 kg

APVMA Approval Number: 34036/20/1206 - KST BA Australia 092006 - 81026623AU002617

Filename: 34036_41315_20_Label_MPL_001.pdf. Dimensions: 280mm x 400mm. Scale: A4 - 66%; A3 - 98%. Date: 9 March 2007

APPROVED

LABEL

Info

pest

Verified

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Granular Soil Fumigant

ACTIVE CONSTITUENT: 940 g/kg DAZOMET

For the control of nematodes, soil inhabiting insects, soil fungi and

germinating seeds of weeds as per the DIRECTIONS FOR USE table.

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

WITHHOLDING PERIOD: NOT REQUIRED WHEN USED AS DIRECTED.

Certis Australia Pty Ltd

24 De Little Circuit

Greenway, ACT 2900

Telephone: 0417 770 958

Batch No.:

Date of Manufacture:

THIS PRODUCT IS NOT CONSIDERED

TO BE A DANGEROUS GOOD UNDER THE

AUSTRALIAN CODE FOR THE TRANSPORT OF

DANGEROUS GOODS BY ROAD AND RAIL.

FOR 24 HOUR SPECIALIST ADVICE IN

EMERGENCY ONLY

PHONE – 0417 770 958

® = Registered trademarks of Kanesho Soil Treatment

BVBA, Belgium.

CODE EAN

DIRECTIONS FOR USE

RESTRAINTS: Do NOT use when soil temperature exceeds 32°C

Do NOT apply to dry soil

PEST

RATE

DEPTH OF

INCORPORATION

METHOD OF APPLICA

TION

SITUATION

Germinating seeds of weeds

or 350 kg/ha

(Increase rate by 17

for each 10 cm

extra depth)

60 to 70 g/m

or 600

to 700 kg/ha

(Increase rate

by 17 g/m

for each

10 cm extra depth

150 to 220 g/m

50 g/m

or 500 kg/ha

(Increase rate by

17 g/m

for each 10

cm extra depth)

10 to 15 cm

30 cm

1. Break up soil to the depth of fumigation 5 to 7 days before applying granules,

removing plant residues and undecomposed roots.

2. Ensure soil is moist for the 5 to 7 days before application of granules. Irrigate

if necessary.

3. Cultivate soil to a fine tilth.

4. Spread granules evenly over surface at the recommended rates.

5. Incorporate thoroughly immediately to recommended depth.

6. Seal surface by covering with plastic sheets, or by irrigating with 20 L

water/m

to form a surface crust, or by rolling.

7. Aerate soils where possible by:

a) piercing holes into plastic sheeting where it is to remain covering the soil,

b) removing plastic, and cultivating to a depth slightly less than that to which

the granules were incorporated.

8. Conduct a germination test 2 to 6 weeks after aeration to ensure no gas

residues remain. Once gases have escaped, planting or sowing may take

place. Details of the Germination Test are in General Instructions.

Note: Do NOT plant into soil until a positive Germination Test has been conducted.

1. Ensure soil is moist 5 to 7 days before application.

2. Mix granules thoroughly at recommended rates. Use soil blending equipment

or treat soil with BASAMID in 10 cm layers mixing with hoe or a fork. Treat

additional layers on top of layers already treated, to form one heap of treated

soil.

3. Seal soil with plastic sheets or store soil in sealed bins.

4. Aerate soil 5 to 7 days after treatment. If soil is not to be used within 6 weeks

of treatment aeration may not be necessary.

5. Wait 2 to 4 weeks after aeration to allow gases to escape before considering

planting.

6. Before planting, conduct a germination test to ensure all gas residues have

escaped before using soil.

Note: Do NOT plant into soil until a positive Germination Test has been conducted.

CRITICAL COMMENTS

Organic matter such as plant roots may delay decomposition of

BASAMID.

Moisture is essential for BASAMID to decompose into gases that kill pests.

Lumpy soil prevents even distribution of gases.

Spreading granules assists even distribution across the soil profile.

Thorough incorporation of granules ensures even distribution of

fumigating gases. Optimum results are obtained using plastic sheeting.

Without plastic sheeting, a reduction in the level of control can be

expected. Where soil temperatures are greater than 20°C or soils are of a

light sandy type that do not crust, plastic sheeting should be used to seal

the soil.

Usually aeration can take place 5 to 7 days after incorporation.

If soil temperature falls below 10°C, wait 14 days. On heavy soils or in

cold weather, extra cultivation may be necessary to aerate the soil

adequately.

Gas residues will cause crop damage. Wait 2 to 3 weeks before

conducting germination test if soil temperature is around 20°C.

Wait 3 to 6 weeks if soil temperature is around 10°C (See Germination

Test under General Instructions).

Moisture is essential for BASAMID to decompose into gases that kill

pests. Thorough mixing is essential for even distribution of fumigating

gases. If soil is dry, water may be added while mixing.

It is essential to prevent gases escaping to enable them time to take

effect.

If soil temperature falls below 10°C wait 14 days before aerating.

Re-mixing of the soil will help aerate the soil. Gas residues will cause

crop damage. (See Germination Test under General Instructions).

20 to 23 cm

Seed beds,

broadacre

Bulk soil

Soil fungi including: Pythium, Phyto-

phthora, Sclerotinia, Sclerotium,

Rhizoctonia, Verticillium, Plasmodio-

phora Armillaria and Fusarium spp.

causing root rot and wilt, clubroot,

and damping off of ornamentals,

vegetables and seedling plants. Soil

insects and non-cyst forming

nematodes.

Germinating seeds of weeds. Soil

fungi including: Pythium,

Phytophthora, Sclerotinia, Sclerotium,

Rhizoctonia, Verticillium,

Plasmodiophora, Armillaria and

Fusarium spp.

causing root rot and wilt, clubroot,

and damping off of ornamentals,

vegetables and seedling plants. Soil

insects and non-cyst forming

nematodes.

Cyst forming nematodes soilfungi and

other pests below 23 cm

GENERAL INSTRUCTIONS

MODE OF ACTION

When the granules come in contact with warm, moist soil,

they release gases. These gases kill actively respiring

nematodes, fungi, insects and weeds, but must be kept

sealed in the soil long enough to complete the fumigating

process. After these gases have sterilised the soil, they must

be completely dissipated before the crop can be planted.

APPLICATION

1. Granules may be spread by gloved hand or with an accurate

drop spreader to moist soil.

2. Incorporate preferably with a rotary hoe or with a hand

hoe.

3. Seal soil surface, preferably with plastic sheeting.

4. Use clean implements to aerate soil to avoid contamination.

5. Do NOT enter glasshouses for 7 days after application

unless wearing personal protective equipment specified

for applicators with goggles and a half face respirator with

organic vapour/gas cartridge.

6. Conduct a successful Germination Test before planting.

PRECAUTIONS

Workers previously experiencing skin or respiratory tract

irritation from dazomet or metham-sodium exposure should

not work with DAZOMET PRODUCTS. Workers performing

manual water-sealing and plastic sealing should wear the

personal protective clothing specified for applicators plus a

respirator with organic vapour/gas cartridge and goggles.

RE-ENTRY PERIOD

Field Uses: Do NOT allow entry into treated areas for 48

hours after application. When prior entry is necessary, wear

personal protective equipment specified for applicators.

Clothing must be laundered after each day's use.

Greenhouse Application, Including Under Plastic:

Do NOT allow entry into treated areas for 7 days after

application. When prior entry is necessary, wear personal

protective equipment specified for applicators with goggles

and a half face respirator with organic vapour/gas cartridge.

Clothing must be laundered after each day's use. Thoroughly

ventilate greenhouses for 24 hours after removing plastic.

RE-HANDLING PERIOD

Potting soil: Treated soil is to remain covered by plastic

sheeting or similar material impermeable to MITC (the active

gas produced by dazomet), for 7 days after treatment. When

prior handling is necessary, wear personal protective

equipment specified for applicators with goggles and a half

face respirator with organic vapour/gas cartridge. Clothing

must be laundered after each day's use.

PROTECTION OF CROPS, NATIVE AND OTHER NON-TARGET

PLANTS

Do NOT sow or plant until Germination Test indicates soil is

free of fumigating gases. Do NOT apply within 60 to 90 cm

of plants or of the root zone of trees or shrubs. If slopes are

treated take precautions that the chemical is not washed

down to growing plants. If using BASAMID in a confined area

(eg. glasshouses), no growing plants should be within that

area, or share the same air supply. If soils contain a high

proportion of organic matter (eg. plant residues, peat, moss,

etc.), the residues of BASAMID may take longer than normal

to disappear. To ensure that conditions are suitable to plant,

apply the Germination Test.

GERMINATION TEST

To ensure that the soil is free from BASAMID gases and

planting can begin, it is essential that a Germination Test is

made on the treated soil.

1. At several places in the treated area, scrape the surface

soil aside and quickly place a sample of soil in a jar. Do

NOT take soil from below the depth of incorporation. When

the jar is three-quarters full it should be immediately

sealed.

2. Three-quarters fill a second jar with untreated soil and

replace the lid.

3. Put cress or lettuce seeds on moist cotton pads or moist

filter paper and place in jars. Immediately replace the

sealing lids.

4. Place the jars in a room with a temperature around 20°C.

5. After 48 hours, check whether the seeds have germinated.

If the seeds have germinated in the jar with the untreated

soil but not in the jar with the treated soil, the toxic gases

have not yet escaped and the soil should be worked again

for aeration.

6. If the seeds with the treated soil germinate normally the

soil is clear and planting can proceed.

PROTECTION OF WILDLIFE, FISH, CRUSTACEANS AND

ENVIRONMENT

Do NOT contaminate streams, rivers and waterways with

product or used container.

STORAGE AND DISPOSAL

Store in the closed, original container in a cool, well-ventilated

area. Do NOT store for prolonged periods in direct sunlight.

Shake container empty onto treated area. Destroy empty

containers by breaking, crushing or puncturing them. Dispose

of the containers at a local authority landfill readily available

in your area, or bury the containers at a depth of 500 mm or

more at a licensed/ approved disposal site. In some States

wastes can only be buried at a licensed landfill. Do NOT burn

empty containers or product.

SAFETY DIRECTIONS

Product is poisonous if swallowed. Will irritate the eyes, nose,

throat and skin. Avoid contact with eyes and skin. Do NOT

inhale dust. The fumes first cause smarting, then watering

of eyes. This should be taken as a warning sign. When

opening the container and using the product wear cotton

overalls buttoned to the neck and wrist (or equivalent

clothing), a washable hat, elbow length (nitrile, neoprene)

gloves and chemical resistant footwear. If product on skin,

immediately wash area with soap and water. After use and

before eating, drinking or smoking, wash hands, arms and

face thoroughly with soap and water. After each day's use,

wash gloves and contaminated clothing. Do NOT re-use

footwear until thoroughly aired.

FIRST AID INSTRUCTIONS

If poisoning occurs, contact a doctor or Poisons Information

Centre. Telephone 131126 Australia-wide.

MATERIAL SAFETY DATA SHEET

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 and State

legislation or law of a Territory.

600 kg

APVMA Approval Number: 34036/600/1206 - KST BA Australia 092006 - 81026624AU002617

Filename: 34036_41315_600_Label_MPL_001.pdf. Dimensions: 280 mm x 400 mm. Scaling: A4 - 66%, A3 - 98%. Date: 9 March 2007

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Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

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

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

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

Published on: Tue, 15 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance dazomet. To assess the occurrence of dazomet residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (including the supporting re...

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

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

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

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

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

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

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

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

29-8-2018

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

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

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Prod.-u. Vertriebsges. mbH & Co. KG, is voluntarily recalling Priano Rosso Pesto Sauce as it may contain undeclared milk and egg. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

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

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (Active substance: glecaprevir / pibrentasvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3916 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4430/T/11

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (Active substance: ombitasvir / paritaprevir / ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3766 of Mon, 11 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3839/T/45

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (Active substance: venetoclax) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3633 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4106/T/12

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (Active substance: dasabuvir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3628 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3837/T/38

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (Active substance: Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3340 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/127/T/149

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (Active substance: lopinavir / Ritonavir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3282 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/368/T/169

Europe -DG Health and Food Safety

16-5-2018

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (AbbVie Deutschland GmbH and Co. KG)

EU/3/14/1305 (Active substance: Humanised recombinant monoclonal antibody against epidermal growth factor receptor conjugated to maleimidocaproyl monomethylauristatin F) - Transfer of orphan designation - Commission Decision (2018)3022 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/065/14/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (AbbVie Deutschland GmbH and Co. KG)

EU/3/17/1954 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3028 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/131/17/T/01

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1767 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3027 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/121/16/T01

Europe -DG Health and Food Safety