ZINEB

Main information

  • Trade name:
  • BARMAC ZINEB FUNGICIDE
  • Pharmaceutical form:
  • Wettable
  • Units in package:
  • 2kg, 10kg, 10kg(20x500g), 20kg, 25kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • AMGROW

Documents

Localization

  • Available in:
  • BARMAC ZINEB FUNGICIDE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BANANA | BEAN | BEET | BOWLING GREEN | CABBAGE | CAPSICUM OR PEPPER | CARNATION | CARROT | CAULIFLOWER | CELERY | CHRYSANTHEMUM
  • Therapeutic area:
  • Group M3 Fungicide
  • Therapeutic indications:
  • ALTERNARIA LEAF BLIGHT OR SPOT BLIGHT | ANTHRACNOSE - COLLETOTRICHUM SPP. | ANTHRACNOSE - ELSINOE ROSARUM | BITTER ROT | BLACK SPOT ON APPLES | BLACK SPOT ON CITRUS | BLACK SPOT ON PEARS | BLUE AND GREEN MOULDS | BLUE MOULD | BROWN CITRUS RUST MITE | CERCOSPORA LEAF SPOT | CERCOSPORA LEAF SPOT - BANANA | CERSOSPORA LEAF BLIGHT OR SPOT | CITRUS BUD MITE | CITRUS RUST MITE OR MAORI MITE | CURVULARIA LEAF SPOT | DOWNY MILDEW | DOWNY MILDEW ON ALLIUM (ONION, GARLIC) | DOWNY MILDEW ON COLE CROP/BRASSICA | DOWNY MILDEW ON CUCURBIT | DOWNY MILDEW ON GRAPE | DOWNY MILDEW ON PEA | DOWNY MILDEW ON ROSE | EARLY BLIGHT ON CELERY | EARLY BLIGHT OR TARGET BLACKSPOT | HELMINTHOSPORIUM DISEASE | LATE OR IRISH BLIGHT ON TOMATO OR POTATO | LEAF BLIGHT | LEAF SPECKLE ON BANANA | LEAF SPOT | PURPLE BLOTCH | ROSE RUST | RUST | SCORCH | SEPTORIA LEAF SPOT - SEPTORIA APIICOLA | SEPTORIA SPOT ON TOMATO | SOOTY BLOTCH ON APPLE, PEAR OR CITRUS | SPECKLED BLOTCH ON CITRUS | STONE FRUIT RUST | ALTERNARIA LEAF SPOT | ALTERNATA SPOT | APP
  • Product summary:
  • For the control of certain diseases of turf, fruit trees, vegetables and ornamentals.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 30628/0702
  • Authorization date:
  • 19-07-2002
  • Last update:
  • 15-06-2017

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

Page 1 of 10

Version Date 10-Oct-02

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

BARMAC

ZINEB

Fungicide

ACTIVE CONSTITUENT: 800g/kg ZINEB

GROUP Y FUNGICIDE

For the control of certain diseases of Turf, Fruit Trees, Vegetables and Ornamentals.as per the

Directions for Use

NET CONTENTS 10, 20, 25 Kg

BARMAC INDUSTRIES PTY LTD

31 Brecknock Street, Archerfield Qld. 4108

Phone 07 3255 6000

Batch Number ……………………………….

Date of Manufacture………. …………………………

Expiry Date: 2 years after date of Manufacture

NRA APPROVAL NUMBER 30628/0702

(Front Panel – pails & multiwalled bags i.e. no inner bag)

Info

pest

Verified

Page 2 of 10

Version Date 10-Oct-02

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

BARMAC

ZINEB

Fungicide

ACTIVE CONSTITUENT: 800g/kg ZINEB

GROUP Y FUNGICIDE

For the control of certain diseases of Turf, Fruit Trees, Vegetables and Ornamentals.as per the

Directions for Use

The inner bag must not be sold separately. Do Not destroy box while product still remains.

NET CONTENTS 2, 10 Kg

BARMAC INDUSTRIES PTY LTD

31 Brecknock Street, Archerfield Qld. 4108

Phone 07 3255 6000

Batch Number ……………………………….

Date of Manufacture………. …………………………

Expiry Date: 2 years after date of Manufacture

NRA APPROVAL NUMBER 30628/0702

(Front Panel 2 Kg & 10 Kg Box)

Page 3 of 10

Version Date 10-Oct-02

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

BARMAC

ZINEB

Fungicide

ACTIVE CONSTITUENT: 800g/kg ZINEB

GROUP Y FUNGICIDE

For the control of certain diseases of Turf, Fruit Trees, Vegetables and Ornamentals.as per the

Directions for Use

Contains 20 x 500 g Measure Packs which

it is illegal to sell separately

NET CONTENTS 10 Kg

BARMAC INDUSTRIES PTY LTD

31 Brecknock Street, Archerfield Qld. 4108

Phone 07 3255 6000

Batch Number ……………………………….

Date of Manufacture………. …………………………

Expiry Date: 2 years after date of Manufacture

NRA APPROVAL NUMBER 30628/0702

(Front Panel – 10 Kg Measure Pack)

Page 4 of 10

Version Date 10-Oct-02

DIRECTIONS FOR USE

Non Tree and Non Vine Crops

Situation

Pest

State

Rate

WHP

Critical Comments

TURF

Bowling Greens

Helminthosporium

(damping off)

NSW, VIC,

SA, TAS,

1.5Kg/800litres

water/full size

green

Apply as preventative every 14-

21days when disease threatens,

or apply when disease first

appears and repeat in 10 days.

Lawns, Golf

Greens, Tennis

Courts

Helminthosporium

(damping off)

NSW, VIC,

SA, TAS,

100g/50 litres

water/100m

Beans

Rust, Anthracnose

NSW, VIC,

SA, WA,TAS

only

150g/100 litres

water

7 Days

Apply when disease threatens

and repeat every ten days as

required.

QLD only

175g/100 litres

water

Bananas

Cercospora Leaf

Spot, Speckle

QLD, NSW,

WA only

2Kg + 4 litres

summer oil/100

litres water/ha

Apply at two week intervals or

as required from December to

May. Water misting.

Beets

Cercospora Leaf

Spot

All States

150g/100 litres

water

Apply when disease threatens.

Repeat if necessary.

Carrots

Cercospora Leaf

Spot ,Alternaria

Leaf Spot

NSW, VIC,

SA WA, TAS

only

150g/100 litres

water

Apply when disease threatens

and repeat at 7 day intervals or

as required. Add 100ml of

Barmac Maxwet

QLD only

175g/100 litres

of water

per 100 litres of water to

improve coverage.

Cauliflower &

Cabbages

Downy Mildew

Cercospora Leaf

Spot

NSW, VIC,

SA, WA, TAS

only

150g/100 litres

water

Apply when disease threatens,

repeat at seven day intervals or

as required.

QLD only

175g/100 litres

water

Add 100ml of Barmac Maxwet

per 100 litres of water to

improve coverage.

Celery

Cercospora Leaf

Spot (Early Blight)

NSW, VIC,

SA, WA, TAS

only

150g/100 litres

water

Apply when plant first comes

through ground in seedbed

Repeat after 7-10 days or as

required. Add

Septoria (leaf spot)

QLD only

175g/100 litres

water

100ml of Barmac Maxwet per

100 litres of water to improve

coverage.

Cucurbits

Downy Mildew

Anthracnose

NSW, VIC,

SA, WA, TAS

only

150g/100 litres

water

7 Days

Apply when weather favours

disease and repeat at 7 day

intervals or as required.

QLD only

175g/100 litres

water

Egg Plant

Early Blight,

Late Blight

All States

150g/ 100 litres

water

Apply when weather favours

disease and repeat at 7 day

intervals or as required.

Onions

Downy Mildew,

Purple Blotch, Blue

Mould

NSW, VIC,

SA, WA, TAS

only

150g/100 litres

water

Apply when disease threatens

and repeat at 7-10 day intervals

or as required. Add 100ml of

Barmac

QLD only

175g/100 litres

water

Maxwet per100 litres of water

to improve coverage.

(Main Label)

Peas, Crucifers

Downy Mildew

All States

125g/100 litres

water

7 Days

Apply every 7-14 days or as

required

Page 5 of 10

Version Date 10-Oct-02

Snow Peas,

Sugar Snap Peas

3 Days

Apply a maximum of 5

applications when disease

threatens at 7-14 day intervals.

Peppers

Early Blight, Late

Blight

All states

150g/100 litres

water

7 Days

Apply when disease threatens

and at 7-10 day intervals.

Potatoes

Early Blight

(Target Spot)

Late Blight

All States

1.7 kg per

Hectare

Apply in at least 650 L

water/ha increasing the volume

with heavy growth to ensure

complete coverage. Commence

sprays at flowering or when

diesase is first expected and

continue at two week intervals.

For aerial or low volume

spraying, apply in 10-20 L

spraying oil or 50-100 litres

water/ha.

Roses, Zinnias,

Carnations,

Chrysanthemum

Rust, Leaf spot,

Downy mildew

NSW, VIC, SA,

TAS, WA only

150g/100 litres

water

Apply when disease threatens

and at 7-10 day intervals or as

required

Snapdragons,

Gladioli

Anthracnose

Curvalaria

QLD only

175g/100 litres

water

Strawberries

Leaf Blight

QLD, WA only

175g/100 litres

water

7 Days

Apply when disease threatens

and as required

Scorch

TAS only

150g/100 litres

water

Tobacco

Blue mould

NSW, VIC

only

170g/100 litres

water

Apply at weekly intervals

during weather conditions

QLD only

230g/100 litres

water

which favour disease.

Tomatoes

Early Blight

(Target spot), Late

Blight,

Anthracnose &

Septoria

NSW, VIC, SA

only

___________

QLD only

150g/100 litres

water

175g/100 litres

water

14 Days

Apply every 14 days when

weather favours disease. A

thorough coverage of leaves is

essential.

(Main Label)

Page 6 of 10

Version Date 10-Oct-02

Tree and vine crops

RATE

In the following table, all rates are given for dilute spraying.

concentrate

spraying

refer

Mixing/Application

section.

CRITICAL COMMENTS

For all uses in this table: Apply by dilute or concentrate

spraying

equipment.

Apply

same

total

amount

product to the target crop whether applying this product

by dilute or concentrate spraying methods.

CROP

DISEASE

STATE

RATE

WHP

CRITICAL

COMMENTS

Citrus

Black Spot

Speckled Blotch

NSW, SA TAS

only

150g/100 litres

water

7 Days

Add 25ml of white oil per 10

litres of water. Spray 6-12

weeks after Bordeaux spray

Scab

QLD only

175g/100 litres

water

at petal fall. When mixing

dilute white oil with water

before adding Zineb. Apply

as an overall spray at the first

signs of activity on fruit.

Brown Citrus Rust

Mite

Citrus Rust Mite

Citrus Bud Mite

QLD only

160g/100 litres

water.

Brown Citrus Rust

Mite

Citrus rust mite

NSW only

100g/100 litres

of water

Apply in January - February.

Grape vines

Downy Mildew

NSW, VIC,

SA, WA, TAS

only

150g/100 litres

of water

Apply at 10 day intervals

during moist humid weather

or as required.

QLD only

175g/100 litres

water

Pome Fruit

Bitter Rot, Sooty

Blotch, Black

Spot of pears

All States

150g/100 litres

water

14 Days

Apply following green tip

spray at pink bud, calyx stage

and cover sprays. Mid

Black spot of

apples

NSW, TAS,

SA, QLD, VIC

only

summer sprays are important

for best bitter rot control.

Peaches, Prunes,

Plums (not early

varieties),

Nectarines

Rust

All states

150g/100 litres

water

14 Days

Add 50ml of White Oil per

10 litres of water. Apply

monthly between December

and March.

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

LABEL UNLESS AUTHORISED UNDER APPROPRIATE LEGISLATION

WITHHOLDING PERIOD:

Snow Peas, Sugar Snap Peas – Do not harvest for 3 days after

application.

Beans, Bananas, Beets, Carrots, Cauliflowers, Cabbages, Celery, Citrus, Cucurbits, Eggplants, Grape

Vines, Onions, Peas and Crucifiers, Peppers and Strawberries - Do not harvest for 7 days after

application.

Pome Fruit, Stone Fruit and Tomatoes - Do not harvest for 14 days after application.

Potatoes, Tobacco – Not required when used as directed.

(Main Label)

Page 7 of 10

Version Date 10-Oct-02

GENERAL INSTRUCTIONS

Mixing/Application

DILUTE SPRAYING: (Tree and Vine Crops) Use a sprayer designed to apply high volumes of water

up to the point of runoff and matched to the crop being sprayed. Set up and operate the sprayer to

achieve even coverage throughout the crop canopy. Apply sufficient water to cover the crop to the

point of runoff. Avoid excessive runoff. The required water volume may be determined by applying

different test volumes, using different settings on the sprayer, from industry guidelines or expert

advice. Add the amount of product specified in the Directions for Use table for each 100 L of water.

Spray to the point of runoff. The required dilute spray volume will change and the sprayer setup and

operation may also need to be changed as the crop grows.

CONCENTRATE SPRAYING (Tree and Vine Crops): Use a sprayer designed and set up for

concentrate spraying (i.e. A sprayer which applies water volumes less than those required to reach the

point of runoff) and matched to the crop being sprayed. Set up and operate the sprayer to achieve even

coverage throughout the crop using your chosen water volume. Determine an appropriate dilute spray

volume (See dilute spraying above) for the crop canopy. This is needed to calculate the mixing rate.

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

EXAMPLE ONLY:

Dilute spray volume as determined above. E.g. 1500 L/ha

Your chosen spray volume. E.g. 500 L/ha

The concentration factor in this example is 3X (i.e. 1500L/500L = 3)

If the dilute rate is 150g/100L, then the concentrate rate becomes 3x150g, that is 450 g/100L of

concentrate spray.

The chosen spray volume, amount of product per 100 L of water and the sprayer setup and operation

may need to be changed as the crop grows. For further information on concentrate spraying, users are

advised to consult relevant industry guidelines, undertake appropriate competency training and follow

industry best practices.

FUNGICIDE RESISTANCE WARNING:

GROUP Y FUNGICIDE

For fungicide resistance management Barmac Zineb Fungicide is a Group Y fungicide. Some

naturally occurring individual fungi resistant to Barmac Zineb Fungicide and other Group Y

fungicides may exist through normal genetic variability in any fungal population. The resistant

individuals can eventually dominate the fungi population if these fungicides are used repeatedly.

These resistant fungi will not be controlled by Barmac Zineb Fungicide and other Group Y fungicides,

thus resulting in a reduction in efficacy and possible yield loss. Since the occurrence of resistant fungi

is difficult to detect prior to use, Barmac Industries Pty Ltd accepts no liability for any losses that may

result from the failure of Barmac Zineb Fungicide to control resistant fungi.

PROTECTION OF LIVESTOCK:

DO NOT graze treated turf/lawn or feed turf/lawn clippings

from any treated area to poultry or livestock.

(Main Label)

Page 8 of 10

Version Date 10-Oct-02

PROTECTION OF WILDLIFE, FISH, CRUSTACEA AND ENVIRONMENT:

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

PROTECTION OF CROPS, NATIVE AND NON TARGET PLANTS:

Do not apply under

meteorological conditions or from spraying equipment which could be expected to cause spray to drift

onto nearby susceptible plants, adjacent crops, crop lands or pastures.

STORAGE AND DISPOSAL

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

Do not store for prolonged periods in direct sunlight. Store in a locked room or place away from

children, animals, food, feedstuffs, seed and fertilisers.

For Rigid Containers:(Plastic Drums & Pails)

Triple or (preferably) pressure rinse containers before disposal. Add rinsings to the spray tank. DO

NOT dispose of undiluted chemicals on site. If recycling replace cap and return clean container to

designated collection point. If not recycling break, crush or puncture and bury empty containers in a

local authority landfill. If no landfill is available, bury the containers below 500 mm in a disposal pit

specifically marked and set up for this purpose clear of waterways, desirable vegetation and tree roots.

For Non Rigid Containers (Paper or Cardboard Bags or Boxes)

Puncture, shred and bury empty containers in a local authority landfill. If no landfill is available, bury

the containers below 500 mm in a disposal pit specifically marked and set up for this purpose clear of

waterways, desirable vegetation and tree roots.

For Plastic Bags

Single rinse bags before disposal. Add rinsings to spray tank. Puncture, shred and bury empty bags in a

local authority landfill. If no landfill is available, bury the bags below 500 mm in a disposal pit

specifically marked and set up for this purpose clear of waterways, desirable vegetation and tree roots.

Empty containers and product should not be burnt.

SAFETY DIRECTIONS

May irritate eyes, nose, throat and skin. Avoid contact with eyes and skin.

Do not inhale dust or spray mist. Wash hands after use.

FIRST AID:

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

131126

MATERIAL SAFETY DATA SHEET:

Additional information is listed on the Material Safety Data

Sheet available from Barmac Industries Pty. Ltd or at our internet site www.barmac.com.au

NOTICE

This product is designed only for the particular purposes indicated on the label. Failure to use the product strictly as

directed may be illegal, prove dangerous and render the product ineffective. The buyer or user is responsible for any

misuse or negligence in the handling, storage, use of or disposal of this material. Barmac Industries Pty Ltd will not accept

any responsibility whatsoever and howsoever arising and whether for consequential loss or otherwise in connection with

the supply and use of this product other than those responsibilities mandatorily imposed by Statutes applicable to the sale

and supply of these goods

(Main Label)

Page 9 of 10

Version Date 10-Oct-02

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

BARMAC

ZINEB

Fungicide

ACTIVE CONSTITUENT: 800g/kg ZINEB

For the control of certain diseases of Turf, Fruit Trees, Vegetables and Ornamentals.as per the

Directions for Use

Before Using Product, read directions on outer pack.

Sale of this bag except in outer pack is illegal.

NET CONTENTS 2Kg, 10Kg

BARMAC INDUSTRIES PTY LTD

31 Brecknock Street, Archerfield Qld. 4108

Phone 07 3255 6000

NRA APPROVAL NUMBER 30628/0702

STORAGE AND DISPOSAL

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

Do not store for prolonged periods in direct sunlight. Store in a locked room or place away from

children, animals, food, feedstuffs, seed and fertilisers.

Single rinse bags before disposal. Add rinsings to spray tank. Puncture, shred and bury empty bags in a

local authority landfill. If no landfill is available, bury the bags below 500 mm in a disposal pit

specifically marked and set up for this purpose clear of waterways, desirable vegetation and tree roots.

Empty containers and product should not be burnt.

SAFETY DIRECTIONS

May irritate eyes, nose, throat and skin. Avoid contact with eyes and skin.

Do not inhale dust or spray mist. Wash hands after use.

FIRST AID:

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

131126

MATERIAL SAFETY DATA SHEET:

Additional information is listed on the Material Safety Data

Sheet available from Barmac Industries Pty. Ltd or at our internet site

www.barmac.com.au

(inner bag)

Page 10 of 10

Version Date 10-Oct-02

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

BARMAC

ZINEB

Fungicide

ACTIVE CONSTITUENT: 800g/kg ZINEB

For the control of certain diseases of Turf, Fruit Trees, Vegetables and Ornamentals.as per the

Directions for Use

Before Using Product, read directions on outer pack.

Not to be sold seperately

NET CONTENTS 500 g

BARMAC INDUSTRIES PTY LTD

31 Brecknock Street, Archerfield Qld. 4108

Phone 07 3255 6000

NRA APPROVAL NUMBER 30628/0702

(Measure Pack bag)

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. 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 lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

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

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

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

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

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

Health Canada

22-11-2018

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

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

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

14-11-2018

“Vita-X Revitalizing Capsules” for men may pose serious health risks

“Vita-X Revitalizing Capsules” for men may pose serious health risks

Health Canada is advising Canadians that two versions of “Vita-X Revitalizing Capsules” by Lanlay Healthmetic Inc., promoted for “long lasting vital energy for men,” may pose serious health risks. One version contains seven capsules and has “NPN 80053009,” a Natural Product Number (NPN) indicating Health Canada authorization, on the label. The second version contains one capsule, has no NPN on the label and is not authorized by Health Canada.

Health Canada

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

30-10-2018

Donorweek 2018: Orgaandonor worden. Dat doe je voor elkaar

Donorweek 2018: Orgaandonor worden. Dat doe je voor elkaar

De donorweek is gestart. Minister Bruno Bruins (Medische Zorg) heeft in dat kader een bezoek gebracht aan de Goudse Scholengemeenschap, Leo Vroman. Tijdens de donorweek is er aandacht voor orgaandonatie en de oproep om te registreren als orgaandonor. Op dit moment staan er nog ruim 1800 patiënten op de wachtlijst voor een orgaan.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

22-8-2018

Rhino 8 Platinum 8000 capsules

Rhino 8 Platinum 8000 capsules

Rhino 8 Platinum 8000 capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

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

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

18-12-2018

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

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

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

Europe -DG Health and Food Safety

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

4-12-2018


Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Overview of comments received on Ibuprofen 200 – 800 mg oral use, immediate release formulations product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

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