IMPEL RODS

Main information

  • Trade name:
  • IMPEL RODS FOR TIMBER PRESERVATION
  • Pharmaceutical form:
  • SLOW RELEASE GENERATOR (INC. FLEA COLLARS)
  • Units in package:
  • 1.75kg,3.5kg,12.5kg,20kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • OSMOSE AUSTRALIA

Documents

Localization

  • Available in:
  • IMPEL RODS FOR TIMBER PRESERVATION
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • TIMBER | WOOD
  • Therapeutic area:
  • Fungicide,Insecticide
  • Therapeutic indications:
  • DECAY PREVENTION OR PRESERVATION | FUNGUS | INSECT PEST OF TIMBER | SOFT ROT | BORERS | FUNGAL LEAF SPOTS | FUNGI | FUNGUS DISEASES | GIVES LONGER LIFE | LEAF SPOT DISEASES | LEAF SPOTS | LYCTIDS | QUARANTINE TIMBER INSECTS | TERMITE | TIMBER DESTROYING INSECTS
  • Product summary:
  • For the pre-treatment of sound timber and remedial treatment of decaying or insect attacked timber.See RESTRAINTS on label

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 30713/05
  • Authorization date:
  • 19-08-1997
  • Last update:
  • 15-06-2017

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

Pane

n Panel

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ

SAFETY DIRECTIONS BEFORE OPENING

USING

IMPEL

TIMBER

PRESERVATION

Product logo placed here

ACTIVE CONSTITUENT: 254

glkg

BORON

present

1000 g/kg DISODIUNf OCTOBORATE ANHYDROUS.

PRE-TREATMENT OF SOUND TIMBER

RElvfEDIAL

TREATMENT OF DECAYING

INSECT ATTACKED TIMBER.

CONTENTS : 500 units

mm x

each.

weight-

-------------

-----------------------

----------

FERNZ TIMBER PROTECTION

(A division

ofFernz

Australia Limited ACN 008 433 0

Cafprico Road, Compton

Mount Gambier,

5290.

Tel:

(08) 8723 1399.

Fax:

(08) 8723

0010.

·-..

........

·.~

::·

A?PRO

V:.~i

*r'zf-::

....

/2:.f:.tl

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

__...,._.,_

- -·

Info

pest

Verified

Two Panel Label

Ancillary Label

DIRECTIONS

(FOR

STATES)

RESTRAINTS:

Only to be used

timber which does not come into direct contact with foodstuffs.

Cutting

llv1PEL

RODS

not recommended.

necessary, score the

using a

--------~EE~_aE~~~e~~~~~aE~~~e~~e_r~~~ti_v~_gJ_a~~e~~l2_d_~~':..e~.-------­

APPLICATION:

Prevention

ofTh1PEL ROD per 500 cm

Timber.

Remedial

Insecticide

ofTh1PEL ROD per 250 cm

Timber.

llviPEL RODS are supplied ready for use.

Holes are to

drilled

the area requiring

treatment to allow insertion

Th1PEL

ROD.

After the rod

inserted, the hole

sealed with a tamper-proof plastic plug or similar item.

Treatment zones are nonnally

adjacent to the End Grain

the timber or at points where the moisture content

timber

conducive

fungal attack,

>20%.

Volume

zone to

treated needs to

calculated to ensure the correct amount ofiMPEL

used.

Refer application rates

above.

necessary holes can be partly filled with Boracol 400RH prior

the Rod

being inserted.

This will allow immediate diffusion to take place.

Inspection

timber

recommended on a regular basis.

the area has been subjected to moisture

levels conducive to fungal attack (>20%) then renewal

the Rod may be necessary.

BE USED

PURPOSE

MANNER

CONTRARY

THIS

LABEL

UNLESS

AUTHORISED

UNDER

APPROPRIATE

LEGISLATION.

GENERAL

INSTRUCTIONS:

llv1PEL

RODS can be used with

types

timber structures (both hardwood and

softwood)

window frames, outdoor furniture, joinery and structural members.

Th1PEL

RODS are effective against wood destroying fungi and soft rot, which

propagate within the cell walls and against wood destroying insects.

They give long

lasting controlled release at strategic points, providing protection where moisture

--------------------2~12.~~~~~~~~~~~-------------------­

PROTECTION

WILDLIFE,

FISH,

CRUSTACEA

ENVIRONMENT

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

STORAGE

AND DISPOSAL:

Store

original packs

a cool, dry, safe place out

direct sunlight.

store

with foodstuffs.

DO NOT use pack for

other purpose.

Destroy empty packs by

breaking, crushing or puncturing them.

Bury packs

a depth

500mm

more in a

safe disposal site or take them to a dump that does not burn its refuse.

Do not burn

--------------------~~~IE~!~~~e_r~~~~-------------------­

SAFETY

DIRECTIONS:

May irritate the nose and throat.

Avoid contact with eyes and skin.

Do not inhale dust.

After use and before eating, drinking and smoking, wash hands,

-------------~~~~~~~~~0~~~~~r~~~~~~E~~~~~------------­

FmsT

AID:

poisoning occurs, contact a doctor or Poisons Information Centre,

lfswa:Howed'"artd''"'~-.--<

··

more than

minutes from hospital, induce vomiting preferabl.y

usi*g·,~~~E9~Cf~

""

;:L0.,,;~

-li.li\...1

'"'""""'-

SYRUP

J\J'?R.0"'\:\~~1

Jofi.1jo5"_,

LAJ!'"

.k...;.~~

st e

....

(1:.

!.·.

:.::.;::.:.:

..

:.::

::

;_~.:

~-~"!:.,~~

.......

BATCH

NUMBER

Date

manufacture.

NRA APPROVAL

NUMBER:

30713\05

-------~~~~~~~~~~~~~~J~~ste~~!~e~~~~~~~~~~~~~~e~~------­

CONDITIONS OF SALE

Fernz Timber Protection (Fernz) shall not

liable for

loss, injury

damage

whether consequential or otherwise whatsoever or however arising whether through

negligence or otherwise in connection with the sale, supply, use or application

this

product.

The supply

this product

on the express condition that the purchaser

does not rely

Fernz's skill or judgement

purchasing or using the same and every

person dealing with this product does so at their own risk absolutely.

representative

ofFernz

has any authority to add to or alter these conditions.

Two Panel

KEEP OUT OF REACH OF CHll..DREN

READ

SAFETY DIRECTIONS BEFORE OPENING

USING

Ii.V1P

E L RODS

TIMBER

PRESERVA

Product logo placed here

ACTIVE CONSTITIJENT:

g!kg BORON (B)

present

LOOO

glkgD

ISODIUM OCTOBORATE ANHYDROUS.

THE PRE-TREAThffiNT

TIMBER

AND REMEDIAL

TREATMENT OF DECAYING OR INSECT ATTACKED T

Th1BER

CONTENTS :

units

x

x

x

each.

-----------

-------~:_t

v:_e~~!:.!~~~~

-----------

------

­

FERNZ

TIMBER PROTECTI

(A division

ofFernz

Australia Limited ACN

008 433 010.)

Cafprico Road, Compton via Mount Gambier, SA

5290.

Tel:

(08) 8723

Fax:

(08) 8723 0010.

-··

' ·

Two Panel Label

Ancillary La bel

DIRECTIO

L STATES)

RESTRAINTS:

Only

be used

timber

which

does

not come into direct

contact

with foodstuffs.

Cutting

IMPEL

RODS

recommended.

necessary,

score

using a

----

--~ri

_:t~~-a~~~~~~~t_~a_:t~

-~-e~~e_r~~~ti_v~_g!~~~~12_d_~~~e~

-------­

APPL1CATIO

Prevention

ofiM

ROD per

Timber.

Remedial

Insecticide

Th1PEL

ROD_Q_er

250 cm

Timber

IMPEL

RODS

supplied

ready

for use. Holes are

be driiJed in

area

requiring

treatment

allow insertion

IMPEL

After

rod is inserted,

hole is

sealed with a

tamper-proof

plastic plug or similar item.

Treatment

normally

adjacent to

Grain

timber

points

where

moisture

content

timber is conducive

fungal

attack

, ie

>20%

.. Volume

be tr

eated

be calculated

sure

correct

amount

IMPEL is used.

Refer

application rates

above.

necessary holes

partly

ed with

Boracol

400RH

prior

being inserted. This will allow immediate diffusion

take

place.

Inspect

timber is recommen

on a

regu

basis.

area

has been subjected

moisrure

levels conducive

fungal

attack

(>20%)

then renewal

may be necessary.

USED

PURPOSE

IN ANY MANNER CONTRARY

TO THIS LABEL UNLESS

THORISED UNDER APPROPRIATE

LEGISLATION.

------

----

- - -

-----

----

----------

----------------

INSTRUCTIONS:

llvfPEL RODS can be used

with

all types

oftimber

structures

(both

hardwood

softwood) in

window

frames,

outdoo

r furniture, joinery and structural members.

IMPEL RO

are effective against

wood

destroying fungi

soft

, which

propagate within

cell walls and against wood destroying insects.

They

give long

lasting contro

ed release

rategic points, providing

protection

where moisture

--------------------~~12.~~~~~~~~~~~~--------

----

- ­

PROTECTION OF

WILDLIF

USTACEA A

ENVIRON

p_?_n_?~~<:_n.!_c:_~~~:_~~~~':_e_:~~r_s.!_f~~~s-~i

~~~~~e~~

a.!_

~~~~~:_o__n!al~e.:_s_:.

STORAG

DISPOSAL:

Store

original packs in a cool, dry, safe place

direct sunlight.

with foodsruffs. DO

pack

for any

other

purpose.

Destroy

empty

packs by

breaking, crushing

puncturing

th~m

Bury packs at a

depth

500mm

more

safe disposal site

take them

a dump that does n

its refuse.

_________________

:_~~tE~~~~~e_r~~~~-----

----

--­

SAFETY DIRECTIONS:

May irritate

nose

throat.

void con

tact

with

eyes and skin.

inhale dust.

After use and before eating, drinking and smoking,

wash

hands,

------

------~~~

~~~~0~~~~~r~~~~~a2!~~~~~~

----

­

poisoning occurs,

contact

doctor

Poisons Information

Centre

swallowed and

more than

minutes from hospital, induce vomiti

preferably

using

m:ECAC

.

SYRUP

APF" .

:"~

1~·\

...

"'"

..:~

?PRO

ViZD

~r'1ftt

LA

!Jt:.

L

Osts .

Ji.:-!.:.<1.

......

....

BATCH

NUNIBER.

Date

manufacture.

-------------------------------------------------------

APPROVAL

NUMBER

: 30713\04

-------~~~.!.i~r:_~~ni~~~~~n_i~~~~d_i~_!~e-~~t_:Ij_~.§~_:~-~a_!~§_~e_:~------­

CONDffiONSOFSALE

Femz

Timber Protection (Fernz) shall

be liable

any loss, injury

damage

whether consequential or otherwise whatsoever

however arising whether through

negligence

otherwise

connection with the sale, supply, use

application

this

product.

The supply

this product

on the express condition that the purchaser

does not rely on Fernz's skill

judgement

purchasing

using the same and every

person dealing with this product does so at their

risk absolutely. No

representative

ofFemz

has any authority to add to

alter these conditions .

··

-·-

......

.,..-

..

Two Panel Label

Main Panel

CAUTION

KEEP OUT OF REACH

CHll..DREN

READ SAFETY DIRECTIONS BEFORE OPENJNG

USING

IMPEL RODS FOR TIMBER PRESERVATION

Product logo placed here

ACTIVE CONSTITUENT:

254 g/kg

BORON (B)

present as

1000

g!kg DISODiillvf OCTOBORATE ANHYDROUS.

PRE-TREATivfENT OF SOUND TIMBER

REMEDIAL

TREATMENT OF DECAYING OR INSECT ATTACKED TIMBER.

CONTENTS:

units

3.5 g

each.

---------------------~~-v:e_i.~!:.l.-2~~~---------------------­

FERNZ

TTh..fBER

PROTECTION

(A division

ofFernz

Australia Limited ACN

008 433 010.)

Cafprico Road, Compton via Mount Gambier, SA

5290.

Tel: (08) 8723 1399.

Fax: (08) 8723 0010.

Panel

Label

Ancillary Label

DIRECTIONS

USE (FOR ALL STATES)

RESTRAINTS:

Only to be used

timber which does not come into direct contact with foodstuffs.

Cutting INfPEL RODS

not recommended.

necessary, score the

using a

--------~ri_E~~_aE~~~~~~~~a_:I~--~e~~~~~~lv~_g!a~~e~~l2_d_~~':._e~.-------­

APPLICATION:

Prevention

ofTh1PEL ROD per 500 cm

Timber.

Remedial

Insecticide

Th1PEL ROD per 250 cm

Timber.

ThlfPEL

RODS are supplied ready for use.

Holes are to be drilled in the area requiring

treatment

allow insertion

the llvfPEL ROD.

After the rod

inserted, the hole

sealed with a tamper-proof plastic plug or similar item.

Treatment zones are normally

adjacent to the End Grain

the timber or at points

where:

the moisture content

timber

conducive to fungal attack, ie

>20o/o.

Volume

zone to be treated needs to

be calculated to ensure the correct amount ofTh1PEL

used.

Refer application rates

above.

necessary holes can be partly filled with Boracol 400RH prior

being inserted.

This will allow immediate diffusion to take place.

Inspection

timber

recommended on a regular basis.

the area has been subjected to moisture

levels conducive to fungal attack

(>20o/o)

then renewal

the Rod may be necessary.

BE USED

PURPOSE

l\tiANNER

CONTRARY

THIS LABEL UNLESS AUTHORISED UNDER

APPROPRIATE

LEGISLATION.

GENERAL

INSTRUCTIONS:

llviPEL RODS can be used with all types

timber structures (both hardwood and

softwood)

window frames,

outdoor

furniture, joinery and structural members.

INfPEL RODS are effective against wood destroying fungi and soft rot, which

propagate within the cell walls and against wood destroying insects.

They give long

lasting controlled release at strategic points, providing protection where moisture

--------------------2~~~~~~~~~~~~~~-------------------­

PROTECTION

\VILDLIFE, FISH, CRUSTACEA AND ENVIRONMENT

Do not contaminate dams, rivers

streams with the chemical

used containers.

-------------------------------------------------------

STORAGE

DISPOSAL:

Store in original packs

a cool, dry, safe place out

direct sunlight.

store

with foodstuffs.

use pack for any other purpose.

Destroy empty packs by

breaking, crushing or puncturing them.

Bury packs at a depth

500mrn

more in a

safe disposal site or take them

a dump that does not bum its refuse.

not burn

--------------------~~~rE~~~~~~~~~~-------------------­

sAFETY

DIRECTIONS:

May irritate the nose and throat.

Avoid contact with eyes and skin.

not inhale dust.

After use and before eating, drinking and smoking, wash hands,

-------------~~~~~~~0~~~~~~~~~~~3E~~~~~------------­

FIRST

AID:

poisoning occurs, contact a

doctor

Poisons Information Centre.

swallowe~

more than

minutes from hospital, induce vomiting preferably

t!~ing:

"IP~CAC

SYRUP APF".

L1

.

'.::

)\~:J

P>f{

~Ji'

''-.c,

~Of/.1/a.Z

LJ\L

'":·~

-~-·

lEE~:;·/t-f·.~l..

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

BATCH

Nillv1BER.

Date

manufacture.

-------------------------------------------------------

APPROVAL Nillv1BER: 30713\0;l.-

-------~j~~~~~i~~~~~~J~Q~~~~~~~~~~~~~~~~-~~~~~~~------­

CONDITIONS OF SALE

Fernz Timber Protection (Femz) shall not be liable for any loss, injury

damage

whether consequential

otherwise whatsoever

however arising whether through

negligence or otherwise

connection with the sale, supply, use

application

this

product.

The supply

this product

on the express condition that the purchaser

does not rely on F ernz' s skill

judgement

purchasing

using the same and every

person dealing with this product does so

their own risk absolutely.

No ·

representative

ernz has any authority

add to

alter these conditions.

....

~,~.~

::.;:~}

:.._:.:·

.·--

J\1'P·r~

r_;;

-~,~~~

Li\.

.,·

;,h. "

Dr;t:J .....

!f.:.f

:.ti:

........

......

·,):\W""\,!:~':,ol.

'<o..-,...

.'1.

' .

.~

,...

,.:·~,i.,

,'

.·\

,,!/

_,',!\_

Panel Label

Main

Panel

CAUTION

KEEP OUT OF

REACH

OF CHILDREN

READ SAFETY DIRECTIONS BEFORE OPENING

USING

Il\tlPEL RODS

Tll\I[BER PRESERVATION

Product

logo placed here

ACTIVE CONSTITUENT: 254 g/kg

BORON

present

1000 g/kg DISODTIJM OCTOBORATE ANHYDROUS.

THE PRE-TREATht1ENT OF SOUND TTh1BER AND REi\1EDIAL

TREATMENT OF

DECAYING

OR INSECT ATTACKED TThtfBER

CONTENTS: 500 units

7 g each.

---------------------~~~~~~~~]}_~~--------------------­

FERNZ

TIMBER

PROTECTION

(A division

ofFernz

Australia Limited ACN

008 433 010.)

Cafprico Roa:d, Compton via Mount Gambier, SA 5290.

Tel: (08)

8723

1399.

Fax: (08)

8723

0010.

Dr'-:,~

....

/!:.f:.tl

..........

Pane)

Label

Ancillary

Label

DIRECTIONS

(FOR

STATES)

RESTRAINTS:

Only

be used

timber which does not come into direct contact with foodstuffs.

Cutting

Th1PEL

RODS

not recommended.

necessary, score the

using a

--------~riE~~-aE~~~~~~~~a_:I~.-~e~~2_f~~~t~v!_gl_~~e~~d-~~~e~·-------­

APPLICATION:

Prevention

oflNIPEL

ROD per

Timber.

Remedial

Insecticide

ofiMPEL

ROD per

Timber.

llvfPEL RODS are supplied ready for use.

Holes are to be drilled

the area requiring

treatment to allow insertion

the .llvfPEL ROD.

After the rod

inserted, the hole is

sealed with a tamper-proof plastic plug or similar item.

Treatment zones are normally

adjacent to the End Grain

the timber

at points where the moisture content

timber

conducive to fungal attack,

>20%.

Volume

zone

be treated needs to

be calculated to ensure the correct amount ofllvfPEL

used.

Refer application rates

above.

necessary holes can be partly filled with Boracol

400RH

prior to the Rod

being inserted.

This

will

allow immediate diffusion to take place.

Inspection

the.

timber

recommended on a regular basis.

Ifthe

area has been subjected

moisture

levels conducive to fungal attack

(>20%)

then renewal

ofthe

Rod may be necessary.

USED

PURPOSE

ANY :MANNER

CONTRARY

TillS

LABEL

UNLESS

AUTHORISED

UNDER

APPROPRIATE

LEGISLATION.

-------------------------------------------------------

GENERAL

INSTRUCTIONS:

llvfPEL RODS can be used with all types

oftimber

structures (both hardwood and

softwood)

window frames,

outdoor

furniture, joinery and structural members.

I11PEL RODS are effective against

wood

destroying fungi and soft rot, which

propagate within the cell walls and against

wood

destroying insects.

They give long

lasting controlled release at strategic points, providing protection where moisture

--------------------2~~~~~~~~~e~~~~-------------------­

PROTECTION

WILDLIFE,

FISH,

CRUSTACEA

ENVlRONM:ENT

not contaminate dams, rivers

streams with the chemical

used containers.

-------------------------------------------------------

STORA.GE

DISPOSAL:

Store

original packs in a cool, dry, safe place out

direct sunlight.

store

with foodstuffs.

use pack for any other purpose.

Destroy empty packs by

breaking, crushing or puncturing them.

Bury packs at a depth

SOOmm

more

in a

safe disposal site or take them to a dump that does not burn its refuse.

not burn

-------------~------~~~tE~~~~~2_f~~~c~-------------------­

SAFETY

DIRECTIONS:

May irritate the nose and throat.

Avoid contact with eyes and skin.

not inhale dust.

After use and before eating, drinking and smoking, wash hands,

-------------~~~!~~~~~0~~~~~r~E~~~a23E~~~~~------------­

FIRST

AID:

poisoning occurs, contact a doctor or Poisons Information Centre.

swallowed and

more than

minutes from hospital, induce vomiting

preferaQ,ly

us{Qg<IPECAC

SYRUP APF".

·:-

~r~~'

BATCH

NUMBER.

Date

manufacture.

-------------------------------------------------------

APPROVAL NillvffiER: 30713\0.3

-------~~~~~~~~~~~~~~nJ~~~~~~~~e~~~~~~~~~~~~~~e~~-------

CONDniTONSOFSALE

Fernz Timber Protection (Fernz) shall not be liable for any loss, injury

damage

whether consequential

otherwise whatsoever or however arising whether through

negligence

otherwise

connection with the sale, supply, use

application

this

product.

The supply

ofthis

product

on the express condition that the purchaser

does not rely on F ernz' s

skill

or judgement in purchasing or using the same and every

person dealing with this product does so at their own risk absolutely.

No·

representative

ofFernz

has any authority to add to

alter these conditions.

. .

<J

.;Ll~.

22-1-2019

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Modification of the existing maximum residue level for trifloxystrobin in broccoli

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

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

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

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

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

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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

2-8-2018

Minister Bruno Bruins bij start Skûtsjesilen

Minister Bruno Bruins bij start Skûtsjesilen

Minister van Sport Bruno Bruins bezoekt zaterdag 4 augustus de start van het jaarlijkse Sintrale Kommisje Skûtsjesilen (SKS) kampioenschap. Hierbij strijden 14 ‘Skûtsjes’ om de felbegeerde kampioenswimpel en de wisseltrofee: het Sulveren Skûtsje.  In totaal worden de komende twee weken 11 wedstrijden gezeild. De eerste wedstrijd start zaterdag op het Pikmeer bij Grou.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

14-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Opinion/decision on a Paediatric investigation plan (PIP): Luspatercept, decision type: , therapeutic area: , PIP number: P/0254/2018

Europe - EMA - European Medicines Agency

17-12-2018


Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Orphan designation: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1->3)-beta-D-galactopyranoside, Treatment of anti-MAG neuropathy, 17/07/2017, Positive

Europe - EMA - European Medicines Agency

14-12-2018


Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Referral: Fosfomycin-containing medicinal products, fosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol, Article 31 referrals, Procedure started, 13/12/2018

Europe - EMA - European Medicines Agency

10-12-2018

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (SFL Regulatory Services GmbH)

EU/3/17/1893 (Active substance: Polyphenyl(disodium 3-O-sulfo-beta-D-glucopyranuronate)-(1?3)-beta-D-galactopyranoside) - Transfer of orphan designation - Commission Decision (2018)8628 of Mon, 10 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/048/17/T/01

Europe -DG Health and Food Safety

24-9-2018

Diacomit (Biocodex)

Diacomit (Biocodex)

Diacomit (Active substance: Stiripentol) - Centralised - Renewal - Commission Decision (2018)6254 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/664/R/21

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

9-7-2018

Pexion (Boehringer Ingelheim Vetmedica GmbH)

Pexion (Boehringer Ingelheim Vetmedica GmbH)

Pexion (Active substance: Imepitoin) - Centralised - 2-Monthly update - Commission Decision (2018)4433 of Mon, 09 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2543/II/11/G

Europe -DG Health and Food Safety

3-7-2018

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Merck Sharp and Dohme B.V.)

Efficib (Active substance: sitagliptin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4254 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/896/T/90

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