ROOTEX-P

Main information

  • Trade name:
  • ROOTEX-P PLANT CUTTING POWDER
  • Pharmaceutical form:
  • DUST
  • Units in package:
  • 18g,250g,500g,1kg,5kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • BASS LABORATORIES

Documents

Localization

  • Available in:
  • ROOTEX-P PLANT CUTTING POWDER
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CUTTING
  • Therapeutic area:
  • PGR
  • Therapeutic indications:
  • ACCELERATION OF ROOT DEVELOPMENT GROWTH
  • Product summary:
  • Strikes and accelerates roots on most plant cuttings.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 33347/0802
  • Authorization date:
  • 29-08-2002
  • Last update:
  • 15-06-2017

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

HOW TO USE:

CUTTING

aboul10em

long

and 1em maximum diameter.

Remove enougll

bottom

leaves to allow

planting.

Moisten cutting

willi

water.

2. INSERT CUTTING INTO ROOTEX-P

and slla\(e

remove

excess

powder.

3. PLANTAS

USUAL.

pols

propagating box using a

mixlu'e

peat

moss and sand or chosen polling

mix.

Water

daly.

keeping mix

moist

DONOT

RETURN

USED

POWDER

TO PACK

NOT TO BE

usso

OTHER PURPOSE, OR IN ANY OTHER

MANNER CONTRARY TO THIS

LABEL

UNLESS AUTHORISED

CAUTiON:

allow

contalnef or product

enter drains. sewers.

streams,

waterways.

STORAGE AND DISPOSAL:

Siore

in closed original

container In a

0001

dark

place out

the reach

ell i1dren.

Dispose

emply container

wrnpplng in a plastic bag

plflling in garbage.

FIRST AID:

II poisoning

OCClUS.

contact a doctor or

Poisons illlormaiion

Centre

131 126.

BASS

LABORATORIES P/L.

9 WALDHEIM RD,

BAYSWATER, VIC.

3153.

(03)

97208177.

NRA Approval

3'33'1"-'

0'2.

BatehNo:

DOM:

ROOTEX-P

Plant

Cutting

Powder

Active constituent

3g1Kg INDOLE BUTYRIC ACID

STRIKES and ACCELERATES

ROOTS on most

PLANT

CUTTINGS

Approx.

600 PLANTS FROM CONTENTS OF THIS PACK

CONTENTS;

18 9

~~~~.

=~:1~~i.J.~~~~

~.I..~~?1

SIgnature:..

.....

"

DO NOT RETURN USED POWDER TO

PACK

NOT TO BE

USED

FOR ANY OTHER PURPOSE OR IN ANY MANNER

CONTRARY TO THIS

lABEL

UNLEsS

AUTHORISED UNDER

APPROPRIATE

lEGISLATION

PROTECTION OF

WilDLIFE.

FISH,

CRUSTACEANS

AND ENIRONMENT:

DO NOT contaminate streams,

rivers or;waterways with the chemical

used

contalnsr,

STORAGE AND DISPOSAL:

Store in closed oliglnal

container

in a dry, cool

well

vantilated area,

of the

reach

ot child/en.

store

proto

nged

penodsm

olrect

sunlight.

Single rinse b<\gbefore disposal,

Dispose of rinsings

and used product

in a pit

specifically marked and set

up for

his purpose.

clear of

waterways,

desirable vegetation and

tree

roots.

Puncture and

bury

empty

containers in a

local

authority landfill.

landfill

is available,

bury the

containers below

500mm

in a disposal

Pit as described above.

Empty containers and

product

should

n'lt

be burnt.

SAFETY

DIRECTIONS:

Wash

hands after

use.

FIRST AID:

If poisoning occurs,

contact

doctor

Poisons inf0/f11afionCentre

131126.

M.S.D.S.: Addifional

information is lisled on Material

SafelY Data Sheet.

TEL: 03 720 8177

BASS

LABO~ATORIES

WaldhelmRd,

Bayswal&r.

VIC.3153.

TEL (03) $720 8177.

TAKE

CUTTING about

10em long and

tern

maximum diameter.

Remove enough

conom

leaves to allow planting.

Moisten cutting with

water,

INSERT CUTTING INTO ROOTEXIP

and shake to remove excess powder.

PLANT

USUAL

In pots or

propaqatlnq

box using a mixture of

peat

moss

sand

Chosen potting mix.

Water daily,

keeplng mix

moist.

DIRECTiONS FOR USE:

use on med'ium

wood

euU"lngs

t"-

~iiii_"

ROOTEX-P

Plant

Cutting Powder

FOR MEDIUM WOOD CUTTINGS

ACTIVE CONSTITUENT:

g/Kg

INDOLE BUTYRIC ACID

NET CONTENTS

STRIKES and ACCELERATES

ROOTS on

most

PLANT CUTIINGS

must

sold

S&paral&ly.

dllSlrOY eonUllner

while

product

stili

remalns.

READ SAFETY DIRECTIONS

BEFORE

OPENING OR USING

NRA APPROVALNO:

Batch No:

DOM:

'.'.'~'::

:.-:.:.~:~~

;::.

... - .., _

.....

"

READ SAFETY DIRECTIONS

BEFORE

OPENING OR USING

ROOTEX-P

Plant

Cutting Powder

ACTIVE CONSTITUENT:

g/Kg

INDOLE BUTYRIC ACID

FOR MEDIUM WOOD CUTTINGS

STRIKES and ACCELERATES

ROOTS on

most

PLANT CUTTINGS

muat

sold

separatBly.

d86KOY

contain,",

while

prodUCt

a1111

.amalna.

NET CONTENTS:

Batch No:

DOM:

NR/\

APPROVAL

3"3

?~4-1

0'1,;0'2...

DIRECTIONS FOR USE:

For use on medium

wood

cuttings

TAKE

CUTTING

about

toorn

long arjd

maximum diameter.

Remove enough bottom

leaves

allow planting.

Moisten CUlling With

water.

INSERT CUTTING INTO ROOTEX-P and

Shake to remove excess powder.

PLANT

USUAL.

In pots

prop'l-gating

box Using a mixture of

peat

moss

and sand or

chosen potting mix.

Waler daily,

keeping mix

moist.

"

DO NOT RETURN USED POWDER TO

PACK

USED

FOR ANY OTHER

~URPOSE

OR IN ANY MANNER

CONTRARY TO THIS

lABEL

UNLESS'

AUTHORISED UNDER

APPROPRIATE

lEGISLATION,

PROTECTION

WILDLIFE, FISH

CRUSTACEANS

AND ENVIRONMENT:

NOT contaminate streams.

rivers or 'waterways with the container or used

container.

STORAGE

DISPOSAL:

Store in closed original

container in a dry. cool

well ventilated area,

the reach of ohildren.

not store for prolonged

periods

n direct

sunlig ht. Si ngle ri

ba,g belo

dlspos

Oispo se of rinsi ngs

used product

in pit

specifically

marked

setup

for this purpose.

clear

waterways,

desirable

vegetation and lree

roots,

Puncture and

bUry

emply

containers in a local

authority landfill.

no landfill

is availabie,

bury the

containers befow 500mm in a disposal

as described above.

Empty containers and prodUct should

by burnt.

SAFETY DIRECTIONS:

Wash hands after use.

FIRST AID:

If poisoning occurs.

contact

doctor

or poisons information Centre

131126.

M.8.D.S: Additional

information is listed on Materia.l SafelY Data Sheet,

TEL: 03 9720 8177

BASS

LABORATORIES

waldile"lm

Ba#wa1e,.

VIC,

3153.

TEL (03) 9720 8177.

'l~r

~j...

READ SAFETY DIRECTIONS

BEFORE

OPENING OR USING

Batch No;

DOM:

NRAAPPROVALNO:

ROOTEX-P

Plant Cuffing Powder

ACTIVE CONSTITUENT:

glKg

INDOLE BUT'fRIC ACID

FOR MEOIUMWOOD CUTTINGS

STRIKES

lind

ACCELERATES

ROOTS

on most

PLANT CUTTINGS

TIls

II1\I$l

""I

be sold

SO!'B'"'oIy.

<IesIroy

coololner

""iIo

fIt<><Ioo!

otiIl.-"s,

NETCONTElffS:

260g

DIRECTIONS

use,

For""" on mediJm'.,ood

_ogo.

TAKE CUTT'NQ

abolJt

100m

Iooll

tnaDn>,Jm

(jja"",lor.

Ao"""",

allO'.>gll_m

....

allOw

olan"'g~

Moisten

ctJllog

.,ill1

'NSERT

CUlllNQ

,NTO

FlOOTEX-P

"'a~

to '''''''''a

0>00

"""dar.

PLAKr

USUAL.'.

pols

lJ'<IO'ISaring

bo.'<

v~og

mi.w,e

pea'moso

Iland

or ""

. ... . .

poIIl""

rID.

&Iy,

k80phg

'"""'-

RETURN

USal

POWDERTO PACK

usee

ANYOTHER

PURPO~'

'101

OTH,ER

MANNER

CONT1I,

loRYTO TH'S

LAlla

UNLESSAlrTHORlSED

UHoER

PPROPRIA

LEGISlA110N.

PROTa:TION OfWlLOLlFE.

FISH,

CRUSTAC

loiS

ENV'RONMENT'

contamlna'.

streams,

riv<lrs

<lr~S

",111

lI1a

d1.n-iea!

Ofconlaln

SlORADE AND

D,SPOSAL:

SIQr"

in _

0000ll08(

i".

dry,

cool

W9l1,onilo'od

"'"

-.I>

OOldn

00 not

""""

p«>Iongod

$111

d~OOl

SOOllghL

Singl.

nnee

bol<

dlSQ<lS3l.

lJis,I>osa

ct ri

I"Il'I

and used

po'OOJct

pi"

lIy rna

""'d

1UPfolll1

pnpose,

c1e"

.,.",n.'v>.

doolrab"evogetatfo.

"""

PU"",",UO

IlUry..,.,Iy

oontairI"",

I"

.looehulllOrily

landfill,

_'10

avaitatjo.

1><:'1

"'.

""".,.,

be"""

OOofl1m

in"

dlspo

,18scri!Jeo

.1>0"",

Empty

0001101""",

aIld

.oould

IIum~

SAFav

DIRECTIONS:

W.....

hands

.!tat

. . . . .

FIRST

AIO:

poiSO.I""

oocurs,

"""laoIa

do<!o'

PoiSOns

"'m"""ti""

Ceo!re

TEL 131 126,

M.s.o.s.,

_nallnlormolon

'sflt;led on

MaterJaJ

SofelyD

8l1"L

TEL:03

97208\71

SASS LAeOR.UORlI;;$ PA

gWaJ:cliel~~dIBoI)I:IiW&lsr,

VK::.31s.a.

1~(O:!jQ12':1I!iI117,

READ SAFETY DIRCTIONS BEFORE OPEING OR USING

ROOTEX-P

Plant Cuffing Powder

ACTlVE CONSTITUEf\lT:

3 glKlI

INDOLE BUTYRIC ACID

FOR MEDIUMWOOD

CUrnNGS

STRIKES

ACCELERATES

ROOTS

moet

PLANT CUTTINGS

roost

be _

sepatately.

dosb'O)/

coota"'e,

while

prodLJCI.II'

..........

NET CONTENTS:

BalChNo:

DoM:

APPROVAL

DlRECYIONS

USE,

Foruse on

.....0;"",

wOOd

cuIlt"l/$.

TAK!;

CUTTlNlhboullQem

Io<'lG

lomma>;r"Jmdamo'."

orJOIJgh

botlOm

"'''''0

allow

plan~.~.

.....

CUlling>

IYiIIJ

.......

INSERT

CUTl1NG

ltITO

AOOTEX·P..,d

,haI<a

relJlO'/e

cess

"""dar.

PlANT AS USUAL In

pets

p<opagaIjng

usi"lla

""'lure

"""t

"""'"

SORl

00"'"

PQtl1ng

rID.

Waler

dolly.

koopn!l

181><

moi,l.

DONOTRETURNUSEOPOWOERTOPACK,

NOTTO BE USEDFORANYOTHER

PURPO~e

OR 'N ANY

crrncR

MANNER

CONTRARY

TO THiS

LABEL UNLESSAUTNOIIlSSDlINOER

loP!'

OPR'ATELEGISLATIOn.

PROTECTION

O.FWlLDUFe, RSH.tRUSTA EANS AND

ENVIRCNMENT~

NOT"'ntaminalO

. ....

. . . . . .

or_v>"""Il1o"".n-i

....

""""I"..,.

STORAGE

lotiO

DISPOSAL:

SI<l<o

In _

glnal

",ntoIn.,

a dry.

DJ<lI

.,.lllr«I1itated

01111.

chl~

nolSlOra

prol0rl(lll(l

pe<j0Ga

IndlfllCl

$unl~L

Singlo

""'"

be"".

dlsposal.

Dispo'.

Ofrloslngs

produ"'"

pilspo\Stlea11y

rnsrklld

am..,

'flls!"J'pose.

daa.-

?fwato",.ys.

vegelatiOnand tree

roote.

Punet:ure

bury er'l¥lly

GorItainililr"S

In a IOefll

8t1l'horlly

I:aJldU.n nc

la<idliIIls

avaJIable.

bury

Il10

_"a,.

betow

5q0"",,

I"

disposal

do,allled abov

EitW

""",,".ora

oncI

fJ'-

should not

~nt.

SAFI;T'f

DIRECTIONS,

Wash

hand>

"

FlAST

AlD~

poIsoojng

occur" "",nlatl

doclllr'"

Pol$oo$lnlo<maliOO

Ceiltta

120.

M.S-D.S-'

Aotilionallntormolion

Iisredon Ms.e.talSalaly

Do... Sh""l.

TEl,

6177,

~l.AI!OMf~E$,p",-

lcliel~FII(~:i,I;;~JtC.

·.-

. . .

..

.::-:.-:.:

..... -'...'-:

:.--::-;:-~

.;:-:

:>::~.~.~-:-:--

--:-

-:-~'.

;:::

READ

SAFETY

DlRECTIONS

BEFORE

OPENING

USING

ROOTEXMP

PLANT

CUTIING

POWDER

AC'T1VIi

CONSTITU

etfr,

INOOLIi llUTYRiC ACID

FOR I4CtUMWOOD

ctm1NBS

6TllIlU!S

ACOIiLl!IlA

ROOTS

. . .. .. ...

I't.AKT Cl1nlNGS

lleI<Inl

ptO<lItt,

dIIectlt1n$ 0011M

CIUIIt

1*11.

$al.0I_

.. ..

~IIIOUClt_lslllefal,

NEt

CONTENTS::

11Cg.

STORAGEA~D

MP(lSAL:

&0<."

_<ItlgIolal....-

in..

oll't.

CIl<II_

.........

0I1f1.

reach

",ikhn.

not_lilt

IlGriocb

indftod

.....

gIlt.

$iI>gI

......

tlofo<e

O!w>'"

~".;ngs

IIId "oed

p<oduct

0ll0d1lcol~

&II

"II

10<

lIIls_

<!4N

ol_tt",.ya.

de"We

-""'"

. . .

100II.

PunoIu

..-.d

buIy.~

_oro

in._

atIIfIoOl)"lon<l".

"no

landfill

!:o"'I

11><1

~Cmrn".

diO»<>oIl

pila>

dlI_abo

. . .

~l)"

00I'Ilain0r1

ptOO.ICI

oho.Adnet""'buml

SAFIiTYDlR

ECnONS:

after

....

FIRST

AID:II

poioonIn;

0XllA,

oonw:t

doc:lot

0<

PaI>oulnl:umaJIonConrreTEl 131 126.

N$~lOfllIIl!S~

'~FId",~.vc.::I1:53..

TIl.~.g~alT1.

NRAAPI'ROVALNO

3i)3l.tl

\c.;<l;;02..

READ

SAFETY

DIRECTIONS

BEFORE

OPENING

USING'

ROOTEX~P

PLANT

CUTTING

POWDER

ACT1V&

CONSTITUENT,

V'Ke

lNOOUI

BUTYRIC

ACID

Foil

MEDIUM

I'IOOD

Clm'lNGS

STIII~es

ancIACCellllATESRllO'TS

PUNT

'*"8

ptOClllOl,

_-*"Ion

....

_peoI<.

Silo

tills

..........

011I'"

poo~

lelle9al-

11IfT

CONTSiTSI

60011

S1'OJU.(I,&

OISPOS.U.:

Srore

11I_

OriQinaI_kla..."

cooI

. . ....

CUl~

'''"'''.

01-"'"

00""'_'"

J>'Qlongocll*lodlln_~SirO'erinselllO

_<liopQuI.

riROlngo

......

lI'O'luetin

pitljlO<ificaj/y

_..-I

setup

fot1Nil

01_.

vegeIalion

no ......

I'\tlcaInt

lItld

lJ,ioy

en'4l'Y

contIl1n

elOClll

aualOriIy

1andII.

1/itldDIia

"'_.burvlllo"",

SOC"",lnadilpooalpitu

Em/l~_Ifld~

_"'Ilo\lum~

SAFETY

tHRIil:TIONS:

nando

a/IoI

usa.

RIIST...

IO<H

~occutt,

OIlIlIa<:ll_.,-,

camr.ra

13t 12S.

... ...... . . .. .

'QOU

....

.......

Il<l.

.VlC.311lf.

lUlllSl,m

1177.

l

NRAAl'PRQVALNOo

'-t'l

o'z,

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

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

17-5-2018

BLM Issues Allergy Alert On Undeclared Egg and Milk

BLM Issues Allergy Alert On Undeclared Egg and Milk

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

FDA - U.S. Food and Drug Administration

2-10-2018

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Merck Sharp and Dohme B.V.)

Rebetol (Active substance: ribavirin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6479 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/246/T83

Europe -DG Health and Food Safety

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

7-8-2018

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Mylan S.A.S.)

Ribavirin Mylan (Active substance: Ribavirin ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5423 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1185/T/29

Europe -DG Health and Food Safety

23-7-2018

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (EUSA Pharma (UK) Limited)

Qarziba (Active substance: dinutuximab beta) - Centralised - Yearly update - Commission Decision (2018)4886 of Mon, 23 Jul 2018

Europe -DG Health and Food Safety

19-6-2018

Maviret (AbbVie Deutschland GmbH and Co. KG)

Maviret (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

11-6-2018

Viekirax (AbbVie Deutschland GmbH and Co. KG)

Viekirax (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

4-6-2018

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

Venclyxto (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

4-6-2018

Exviera (AbbVie Deutschland GmbH and Co. KG)

Exviera (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

29-5-2018

Norvir (AbbVie Deutschland GmbH and Co. KG)

Norvir (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

25-5-2018

Kaletra (AbbVie Deutschland GmbH and Co. KG)

Kaletra (AbbVie Deutschland GmbH and Co. KG)

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

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

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

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

Europe -DG Health and Food Safety

16-5-2018

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (AbbVie Deutschland GmbH and Co. KG)

EU/3/16/1766 (Active substance: Venetoclax) - Transfer of orphan designation - Commission Decision (2018)3026 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/122/16/T/01

Europe -DG Health and Food Safety