KUMULUS DF

Main information

  • Trade name:
  • KUMULUS DF WETTABLE SULPHUR FUNGICIDE SPRAY
  • Pharmaceutical form:
  • WDG
  • Units in package:
  • 15kg,25kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • BASF AUSTRALIA

Documents

Localization

  • Available in:
  • KUMULUS DF WETTABLE SULPHUR FUNGICIDE SPRAY
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CITRUS | GRAPEVINE | KIWI FRUIT | MANGOSTEEN | ORNAMENTAL | POME FRUIT | RAMBUTAN | STONE FRUIT (SEE LABEL FOR EXCEPTIONS) | STR
  • Therapeutic area:
  • Group M2 Fungicide
  • Therapeutic indications:
  • BEAN OR BROAD BEAN RUST- U. VICIAE-FABAE | BEAN SPIDER MITE | BLACK SPOT - VENTURIA SPP. | BROWN CITRUS RUST MITE | BROWN FRUIT ROT - MONILINIA FRUCTICOLA | BUD MITE | CARMINE MITE | CITRUS BUD MITE | CITRUS MELANOSE | CITRUS RUST MITE OR MAORI MITE | GRAPELEAF BLISTER MITE | LICHEN | MITE | MOSS | POWDERY MILDEW | POWDERY MILDEW ON CAPSICUM OR TOMATO | POWDERY MILDEW ON GRAPEVINE | POWDERY MILDEW ON POME | POWDERY MILDEW ON STRAWBERRY | RUST - UROMYCES SPP. | RUST MITE | STONE FRUIT RUST | TOMATO RUSSET MITE | WHITE LOUSE SCALE | BLACK SPOT (SCAB) | BLOSSOM BLIGHT | BROWN CITRUS MITE | BROWN ROT | CITRUS RUST MITES | CITRUS SNOW SCALE | RED SPIDER MITE | RUST MITE | SPHAEROTHECA MACULARIS | SPIDER MITE | TOMATO MITE (47236) | TRANSZCHELIA PRUNI-SPINOSAE | TWO-SPOTTED MITE | TWO-SPOTTED SPIDER MITE | UROMYCES PHASEOLI VAR. TYPICA | VINELEAF BLISTER MITE
  • Product summary:
  • For the control of certain fungal diseases and mites in grapevines and other crops.DO NOT apply to cucumbers, rockmelons or apricots as these plants exhibit low tolerance to sulfur. High rates are detrimental to some natural enemies of pests. See also RESTRAINTS on label.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 30552/61794
  • Authorization date:
  • 21-03-2014
  • Last update:
  • 15-06-2017

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

KUMULUS

TTABLE

SULPHUR

FUNGICIDE

SPRAY

KUMULUS® DF

Approved

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

ACTIVE CONSTITUENT: 800

g/kg

SULPHUR

IGROUP

l&tJFuNGICIDE

the control

certain fungal diseases and mites

grapevines and other crops

DIRECTIONS FOR USE table.

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE USING THIS PRODUCT.

NET CONTENTS: 15kg, 25kg

BASF Australia Ltd ABN 62 008 437 867

Level 12, 28 Freshwater Place Southbank VICTORIA 3006

Registered trademark

BASF

APVMA

Approval No

3055o/

61/qf

Page

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

Label

Page

DBASF

The

Chemfcal

Company

STORAGE

DISPOSAL

Store

closed,

original

container

dry,

cool,

well-ventilated

area

direct

sunlight.

special

formulation

KUMULUS

requires

that

kept

sealed

prevent

deterioration.

Single

rinse

before

disposal.

rinsings

spray

tank.

dispose

undiluted

chemicals

site.

Puncture

bury

empty

containers

local

authority

landfill.

landfill

available,

bury

containers

below

disposal

specifically

marked

this

purpose

clear

waterways,

desirable

vegetation

tree

roots.

Empty

containers

product

should

burnt.

MATERIAL

SAFETY

DATA

SHEET

Additional

info1111ation

listed

Material

Safety

Data

Sheet.

CONDITIONS

SALE

conditions

warranties

rights

remedies

implied

arising

contract

tort

whether

negligence

BASF

Australia

otherwise

hereby

expressly

excluded

same

legally

done

provided

however

that

rights

Buyer

pursuant

non-

excludable

conditions

warranties

Trade

Practices

1974

relevant

legislation

State

expressly

preserved

liability

BASF

Australia

intermediate

Seller

pursuant

thereto

shall

limited

pe1111itted

said

legislation

replacement

goods

sold

supply

equivalent

goods

liability

indirect

consequential

loss

damage

whatsoever

nature

expressly

excluded.

This

product

must

used

applied

strictly

accordance

with

instructions

appearing

hereon.

This

product

solely

sold

Australia

must

exported

without

prior

written

consent

BASF

Australia

Ltd.

APVMAApproval

30552/611~4

Batch

Date

Manufacture:

BASF

Australia

Level12,

Freshwater

Place

Southbank

VICTORIA

3006

SPECIALIST

ADVICE

EMERGENCY

ONLY

PHONE

1800

TOLL

FREE-ALL

HOURS-AUSTRALIA

WIDE

Page

2 of9

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

Leaflet

DBASF

Chermcal

Company

KUMULUS® DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

ACTIVE CONSTITUENT: 800 g/kg SULPHUR (S)

For the control of certain fungal diseases and mites

grapevines and other crops as per the

DIRECTIONS FOR USE table.

IMPORTANT: READ THE ATTACHED LEAFLET BEFORE USING THIS PRODUCT..

NET CONTENTS: 15kg, 25kg

BASF Australia Ltd ABN 62 008 437 867

Level12, 28 Freshwater Place Southbank VICTORIA 3006

Registered trademark of BASF

APVMA Approval No.:

30552/

bllq4-

Page

3 of9

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

Leaflet

DBASF

The

Chemical

Company

DIRECTIONS

RESTRAINTS:

apply

within

weeks

spray.

with

oils

formulations

containing

mineral

oil.

TREE

VINE

CROPS

RATE

CRITICAL

COMMENTS

following

table,

rates

given

dilute

spraying.

tree

vine

crop

uses

this

concentrate

spraying,

refer

Application

section

table:

Apply

dilute

concentrate

spraying

equipment.

Apply

same

total

amount

product

target

crop

whether

applying

this

product

dilute

concentrate

spraying

methods.

CROP

PEST/DISEASE

STATE

RATE

~/100

Citrus

Cjtrus

rust

mite

Qld,

NSW,

Spray

July

August

with

thorough

Phyllocoptruta

oleivora),

Vic,

coverage.

citrus

brown

citrus

rust

mite

WAonly

weather.

higher

rates

heavy

(Tegolophus

australis),

infestations.

Leave

least

weeks

citrus

mite

(Eriophyes

between

sprays

product.

she/dom),

moss,

lichens

Citrus

Citrus

mite

only

NSW,

application

will

assist

control.

Eriophyes

she/dam)

added

copper

spray

petal

fall

Melanose

NSW,

applied

separately

during

spring

autumn.

White

louse

scale

Unaspis

only

higher

rates

heavy

infestations.

citn)

Page

4 of9

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

RATE

following

table,

rates

given

dilute

spraying.

concentrate

spraying,

refer

Application

section

Leaflet

The

Chemical

Company

CRITICAL

COMMENTS

tree

vine

crop

uses

this

table:

Apply

dilute

concentrate

spraying

equipment.

Apply

same

total

amount

product

target

crop

whether

applying

this

product

dilute

concentrate

spraying

methods.

CROP

PEST/DISEASE

STATE

RATE

111100

Grapevines

Rust

mite

Calepitrimerus

vitis)

mite

Grape

leaf

blister

mite

Cofomerus

vitis)

states

600*

Apply

dilute

spray

mixture

with

canol

(eg.

Supastik

OOL)

between

budswell

mid-late

woolly

stage

apply

alone

between

woolly

soon

after

budburst.

These

treatments

will

less

effective

phytotoxic

applied

concentrate

sprays

should

applied

dilute

spray

volume

that

results

visible

wetting

buds,

canes

cordons

when

temperature

least

during

application

several

hours

afterwards.

wood

crowns,

cordons

canes

should

thoroughly

with

this

application.

apply

mixture

with

canola

after

woolly

stage

crop

phytotoxicity

will

occur.

*High

rates

wettable

sulphur

detrimental

some

natural

enemies

pests

especially

parasitoids

Mealybug

Light

Brown

Apple

Moth.

Apply

dilute

spray

between

budburst

basal

nodes

week

later.

This

treatment

will

less

effective

applied

concentrate

spray

should

only

applied

dilute

spray

volume

that

results

visible

wetting

buds,

canes

cordons

when

temperature

least

during

application

several

hours

afterwards.

During

summer,

build

blister

m~es

checked

sulphur

sprays

powdery

mildew,

early

budburst

spray

very

important

mite

control.

Page

5 of9

-~---------~--------------------------------~~~~,~----~---

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

Leaflet

DBASF

The

Chemical

Company

CROP

PEST/DISEASE

STATE

RATE

g/100

Grapevines

Powdery

mildew

Uncinula

states

600*

Only

higher

rates

beginning

cont.

necator)

season

when

temperatures

lower

(15o

20°

application).

Temperatures

should

least

15°

during

application

several

hours

afterwards

achieve

effective

controL

Thorough

coverage

required

provide

effective

controL

apply

when

both

temperature

exceeds

30°

relative

humidity

exceeds

crop

phytotoxicity

occur.

Kiwifruit

Twospotted

mite

NSW,

Spray

only

when

pest

present

Tetranychus

urticae)

WAonly

Repeat

application

only

when

necessary.

apply

during

weather.

Mangosteen

Powdery

mildew,

mites

states

Apply

foliar

spray.

Spray

when

pests

present

Repeat

applications

only

when

necessary.

apply

during

weather.

Pome

fruit

Powdery

mildew

States

Apply

least

sprays

before

blossom.

(Podosphaera

NSW,

Apply

fortnightly

after

blossom.

Leucotricha)

Vic,

Tas,

lower

rate

weather

spraying

SA,WA

non-sensitive

varieties.

only

sulphur-sensitive

apple

pear

varieties

weather.

only

Also

suppresses

mite

development.

Black

spot

(scab)

(Venturia

Vic,

Tas,

Apply

pink

bud,

petal

fall

then

spp.)

only

intervals

weeks.

only

sulphur-sensitive

apple

pear

varieties

weather.

Also

suppresses

mite

development

Rambutan

Powdery

mildew,

mites

states

Apply

foliar

spray.

Spray

when

pests

present.

Repeat

applications

only

when

necessary.

apply

during

weather.

Stone

fruit

Rust

Tranzschelia

NSW,

Apply

about

weeks

after

petal

fall

(except

discolor)

Vic,

Tas,

petal

fall

only)

intervals

apricots)

SA,WA

weeks

until

late

January.

only

higher

rate

when

disease

incidence

high.

only

Brown

{fruit)

NSW,

Apply

weeks

after

petal

fall

then

cover

(Monilinia

fructicola)

Vic,

Tas,

sprays.

only

only

Apply

petal

fall

only.

Page

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

Leaflet

DBASF

The

Chemical

Company

RATE

CRITICAL

COMMENTS

following

table,

rates

given

dilute

spraying.

tree

vine

crop

uses

this

concentrate

spraying,

refer

Application

section

table:

Apply

dilute

concentrate

spraying

equipment.

Apply

same

total

amount

product

target

crop

whether

applying

this

product

dilute

concentrate

spraying

methods.

CROP

PEST/DISEASE

STATE

RATE

g/100

Ornamentals

Powdery

mildew,

Vic,

Tas,

Apply

when

pest

disease

first

seen

twospotted

mite

SA,WA

repeat

every

days.

Tetranychus

urticae)

only

only

g/100

Powdery

mildew

NSWonlv

g/100

Strawberries

Powdery

mildew

NSW,

Apply

when

disease

first

noted,

then

only

g/100

L .

intervals

during

humid

weather.

Tomatoes

Powdery

mildew,

bean

Vic,

Tas,

kg/ha

Apply

when

pest

disease

first

seen

processing

rust,

tomato

russet

mite,

repeat

necessary.

Crop

phytotoxicity

bean

spider

mite,

only

occur

when

applications

occur

during

twospotted

mite

conditions.

apply

during

heat

Powdery

mildew,

bean

NSWonly

day.

rust,

tomato

russet

mite,

bean

spider

mite

Vegetables

Powdery

mildew,

rust

Vic,

Tas,

200to

Apply

when

pest

disease

first

seen

(NOT

(Uromyces

spp.),

repeat

every

days.

cucumbers

tomato

russet

mite,

only

higher

rate

crops

with

rockmelons)

(Acutops

tycopersici),

NSWonly

large

leaf

cover

when

conditions

favour

bean

spider

mite

disease

and/or

mite

development.

Tetranychus

tudem)

apply

during

heat

day.

Twospotted

mite

Vic,

Tas,

(Tetranychus

urticae)

SA,WA

only

Powdery

mildew,

rust

only

(Uromyces

spp.),

tomato

russet

mite

USED

PURPOSE,

MANNER,

CONTRARY

THIS

LABEL

UNLESS

AUTHORISED

UNDER

APPROPRIATE

LEGISLATION.

WITHHOLDING

PERIODS:

REQUIRED

WHEN

USED

DIRECTED.

GENERAL

INSTRUCTIONS

FUNGICIDE

RESISTANCE

WARNING

GROUP

IIW<I

FUNIGICIDE

KUMULUS

member

multi-site

activity

group

fungicides.

fungicide

resistance

management

KUMULUS

Group

fungicide.

Some

naturally

occurring

individual

fungi

resistant

KUMULUS

other

Group

fungicides

exist

through

normal

genetic

variability

fungal

population.

resistant

individuals

eventually

dominate

fungi

population

these

fungicides

used

repeatedly.

These

resistant

fungi

will

Page

7 of9

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

Leaflet

DBASF

The

Chemical

Company

controlled

KUMULUS

other

Group

fungicides,

thus

resulting

reduction

efficacy

possible

yield

loss.

Since

occurrence

resistant

fungi

difficult

detect

prior

use,

BASF

Australia

accepts

liability

losses

that

result

from

failure

KUMULUS

control

resistant

fungi.

MIXING

Slowly

pour

KUMULUS

into

spray

tank

three-quarters

filled

with

water,

with

agitation

system

actively

moving.

Alternatively,

premix

bucket,

adding

KUMULUS

quantity

water

least

half

volume

KUMULUS

stir

immediately.

this

mixture

bulk

water

spray

with

agitation

running.

tank

mixing

with

another

product,

always

Kumulus

spray

tank

first.

Tank

mixtures

containing

Kumulus

should

left

overnight

before

use.

Apply

spray

immediately

avoid

settling.

APPLICATION

Tree

crops

vines

Dilute

Spraying

sprayer

designed

apply

high

volumes

water

point

run-off

matched

crop

being

sprayed.

operate

sprayer

achieve

even

coverage

throughout

crop

canopy.

Apply

sufficient

water

cover

crop

point

run-off.

Avoid

excessive

run-off.

required

water

volume

determined

applying

different

test

volumes

using

different

settings

sprayer,

from

industry

guidelines

expert

advice.

amount

product

specified

Directions

table

each

water.

Spray

point

run-

off.

required

dilute

spray

volume

will

change

sprayer

set-up

operation

also

need

changed

crop

grows.

Concentrate

Spraying

sprayer

designed

concentrate

spraying

(that

sprayer

which

applies

water

volumes

less

than

those

required

reach

point

run-off)

matched

crop

being

sprayed.

operate

sprayer

achieve

even

coverage

throughout

crop

canopy

using

your

chosen

water

volume.

Determine

appropriate

dilute

spray

volume

(See

Dilute

Spraying

above)

crop

canopy.

This

needed

calculate

concentrate

mixing

rate.

mixing

rate

concentrate

spraying

then

calculated

following

EXAMPLE

ONLY

Dilute

spray

volume

determined

above:

example

1500

Your

chosen

concentrate

spray

volume:

example

concentration

factor

this

example

(i.e.

1500

dilute

label

rate

then

concentrate

rate

becomes

200,

that

concentrate

spray.

chosen

spray

volume,

amount

product

water,

sprayer

set-up

operation

need

changed

crop

grows.

further

information

concentrate

spraying,

users

advised

consult

relevant

industry

guidelines,

undertake

appropriate

competency

training

follow

industry

Best

Practices.

WETTING

AGENT

leaves

fruit

hairy

waxy,

where

water

hard,

non-ionic

wetting

agent

approved

label

rate.

COMPATIBILITY

KUMULUS

compatible

with

most

insecticides,

fungicides

foliar

fertilisers

including

Polyram®

!hiram,

ziram,

Scala+,

Mycloss+,

carbaryl,

azinphos,

urea,

Foliar

Nitrophoska®,

Wuxal+

Foliar

Nutrient

Wuxal

Calcium

Foliar

Nutrient.

KUMULUS

compatible

with

oils

formulations

containing

mineral

oil.

PROTECTION

WILDLIFE,

FISH,

CRUSTACEANS

ENVIRONMENT

contaminate

streams,

rivers

waterways

with

this

product

used

containers.

Page

KUMULUS®DF

WETTABLE

SULPHUR

FUNGICIDE

SPRAY

Leaflet

DBASF

The

Chemical

Company

PROTECTION

CROPS,

NATIVE

OTHER

NON-TARGET

PLANTS

apply

under

weather

conditions

from

spraying

equipment

which

could

expected

cause

spray

drift

onto

nearby

susceptible

plants,

adjacent

crops,

crop

lands

pastures.

spray

cucumbers,

rockmelons

apricots

these

plants

exhibit

tolerance

sulphur.

Where

there

range

rates,

apply

lower

rate

during

months

avoid

scorching.

RE-ENTRY

PERIOD

KUMULUS

toxicity

initancy,

therefore

specific

requirements

re-entry

into

treated

areas

indicated

STORAGE

DISPOSAL

Store

closed,

original

container

dry,

cool,

well-ventilated

area

direct

sunlight.

special

formulation

KUMULUS

requires

that

kept

sealed

prevent

deterioration.

Single

rinse

before

disposal.

rinsings

spray

tank.

dispose

undiluted

chemicals

site.

Puncture

bury

empty

containers

local

authority

landfill.

landfill

available,

bury

containers

below

disposal

specifically

marked

this

purpose

clear

waterways,

desirable

vegetation

tree

roots.

Empty

containers

product

should

burnt.

MATERIAL

SAFETY

DATA

SHEET

Additional

information

listed

Material

Safety

Data

Sheet.

CONDITIONS

SALE

conditions

warranties

rights

remedies

implied

arising

contract

tort

whether

negligence

BASF

Australia

otherwise

hereby

expressly

excluded

same

legally

done

provided

however

that

rights

Buyer

pursuant

non-

excludable

conditions

warranties

Trade

Practices

relevant

legislation

State

expressly

preserved

liability

BASF

Australia

intermediate

Seller

pursuant

thereto

shall

limited

permitted

said

legislation

replacement

goods

sold

supply

equivalent

goods

liability

indirect

consequential

loss

damage

whatsoever

nature

expressly

excluded.

This

product

must

used

applied

strictly

accordance

with

instructions

appearing

hereon.

This

product

solely

sold

Australia

must

exported

without

prior

written

consent

BASF

Australia

Ltd.

APVMA

Approval

30552/

Batch

Date

Manufacture:

Registered

trademark

BASF

Other

Trademarks

DBASF

Chemical

Company

BASF

Australia

Level12,

Freshwater

Place

Southbank

VICTORIA

3006

SPECIALIST

ADVICE

EMERGENCY

ONLY

PHONE

1800

TOLL

FREE-ALL

HOURS-AUSTRALIA

WIDE.

Page

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

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

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

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