RAMETIN SHEEP DRENCH

Main information

  • Trade name:
  • RAMETIN SHEEP DRENCH
  • Pharmaceutical form:
  • ORAL SOLUTION/SUSPENSION
  • Units in package:
  • 750g,1.5kg
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • BAYER AUSTRALIA

Documents

Localization

  • Available in:
  • RAMETIN SHEEP DRENCH
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • LAMB | SHEEP | EWE | HOGGET | LAMB | OVINE | RAM | WEANER | WETHER
  • Therapeutic area:
  • anthelmintic
  • Therapeutic indications:
  • BARBER'S POLE WORM-HAEMONCHUS CONTORTUS | BLACK SCOUR WORM - TRICHOSTRONGYLUS SPP. | SMALL BROWN STOMACH WORM-OSTERTAGIA SPP. | STOMACH HAIR WORM | THIN NECKED INTESTINAL WORM | HAIR WORM | INTESTINAL HAIR WORM | SMALL HAIR WORM | TELADORSAGIA
  • Product summary:
  • For the control of organophosphate susceptible strains of gastrointestinal mature and immature roundworms in sheep and lambs.See CONTRAINDICATIONS & PRECAUTIONS on label. Do not use in female sheep which are producing, or may in the future, produce milk or milk products for human consumption.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered but not available
  • Authorization number:
  • 35800/0710
  • Authorization date:
  • 12-08-2010
  • Last update:
  • 15-06-2017

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

ACTIVE CONSTITUENT: 800 g/kg NAPHTHALOPHOS

(AN ANTICHOLINESTERASE COMPOUND)

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

APVMA Approval No: 35800/750 g/0710

For the control of organophosphate susceptible strains of

gastrointestinal mature and immature roundworms in

sheep and lambs.

Sheep Drench

Rametin

®

Contents when packed

750 g NET

Contents when reconstituted

5 Litres

5L_Front (230 x 140mm)

35800_50159_5L_Immediate_MPL_V01

Date: 0710

Dimensions: 230 x 140 mm

Scale: 100% when printed at 100% magnfication to A3

RLP

APPROVED

Info

pest

Verified

9 310160 659521

APVMA Approval No: 35800/750 g/0710

See bottle for batch number and expiry date

STORAGE: Store below 30°C

(room temperature) in original container,

tightly closed, in a safe place.

See drum for expiry date and batch number

POSITIONAL ONLY

CUSTOMER INFORMATION LINE

1800 678 368

TOLL FREE from anywhere in Australia

9:00am to 4:00pm (Eastern Time) Monday to Friday

www.bayeranimal.com.au

Bayer Australia Ltd. ACN 000 138 714.

875 Pacific Highway, PYMBLE, NSW, 2073

RAMETIN

is a registered trademark of Bayer AG,

Leverkusen, Germany.

Manufactured in Germany

Sheep Drench

Rametin

®

UN No. 2783

1 800 033 111

Australia wide, 24 hours

emergency contact

Bayer Australia Limited

6

TOXIC

ORGANOPHOSPHORUS

PESTICIDES, LIQUID, TOXIC

RAMETIN

contains naphthalophos, a member of the organophosphorus family of

chemicals. It is effective against organophosphate susceptible strains of mature

and immature stages of Barber's Pole worm (Haemonchus contortus), Stomach

Hair worm (Trichostrongylus axei), Black Scour worm (Trichostrongylus spp.),

Small Brown Stomach worm (Ostertagia spp.), and mature stages of Thin Necked

Intestinal worm (Nematodirus spp.) in sheep and lambs.

RAMETIN

will control strains resistant to other drench groups but resistance may

develop to any drench product. Advice on internal parasite management to reduce

development of resistance should be obtained from your veterinary practitioner or

animal health consultant. It is advisable that a resistance test be conducted before

any parasite treatment is used. If drench failure is suspected, seek veterinary

confirmation and notify the manufacturer.

DIRECTIONS FOR USE:

RESTRAINTS:

DO NOT USE in female sheep which are producing, or may in the future produce,

milk or milk products for human consumption.

CONTRAINDICATIONS:

This product is contraindicated for use in severely debilitated, stressed or drought

affected animals or those affected by lupinosis.

This product is contraindicated for use in thirsty, exhausted sheep or those

suffering from poor nutrition.

This product is contraindicated for use in lambs less than 6 kg.

PRECAUTIONS:

Seek veterinary advice before administering at the same time as any other drench.

Allow animals access to water after treatment.

Use care when drenching. Avoid misdirecting dosage into the lungs.

Check the accuracy of the drench gun before starting to treat.

Ask your local veterinary practitioner or animal health advisor for recommended

parasite management practices for your area to reduce development of resistance.

DOSAGE AND ADMINISTRATION:

6 - 7.5

7.6 - 9

9.1 - 12

12.1 - 16

16.1 - 20

20.1 - 28

28.1 - 40

40.1 - 52

52.1 - 68

68.1 - 90

Bodyweight kg

Dose Volume

mL of prepared drench

2,500

2,000

1,666

1,250

1,000

Number of Sheep

treated per pack

A representative sample of animals should be weighed before treatment.

Dose the mob to the heaviest animal by liveweight in each group (ewes, wethers,

rams, lambs).

Where there is a large variation in size within the group, dose rate should be based

on the label direction for each weight range. Drafting into two or more lines may be

appropriate, to avoid excessive overdosing.

WITHHOLDING PERIODS:

MEAT - DO NOT USE

less than 7 days before slaughter for human consumption.

MILK - DO NOT USE

in female sheep which are producing, or may

in the future produce, milk or milk products for human consumption.

TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI):

DO NOT USE less than 7 days before slaughter for export. The ESI on this label was

correct at the time of label approval. Before using this product, confirm the current

ESI from the manufacturer on [Customer Information Line 1800 678 368 Monday to

Friday 9am to 4pm EST] or the APVMA website

(www.apvma.gov.au/residues/ESI.shtml).

MIXING INSTRUCTIONS:

RAMETIN

mixes readily with all types of water. Its

high suspensibility ensures a consistent and uniform suspension during drenching.

If product is left standing, shake well before using. RAMETIN

Sheep Drench is

stable after mixing for up to 3 months when stored at 20°C.

Remove large cap and half fill container slowly with water. Replace cap and shake

well. Then remove cap and top up with water to the fill line shown. Replace cap and

shake well for 3 minutes. RAMETIN

may be mixed with benzimidazole and

levamisole based drench product under veterinary advice. RAMETIN

Sheep Drench

is compatible with copper sulphate.

SAFETY DIRECTIONS:

Very dangerous. Product and drench are poisonous if

absorbed by skin, inhaled or swallowed. May irritate the eyes and skin. Repeated

exposure may cause allergic disorders. Repeated minor exposure may have a

cumulative poisoning effect. Avoid contact with eyes and skin. Do not inhale dust.

When opening the container and preparing drench wear cotton overalls buttoned to

the neck and wrist (or equivalent clothing), PVC or rubber apron, elbow length

chemical resistant gloves and a disposable dust face mask covering mouth and nose.

When using the prepared drench wear cotton overalls buttoned to the neck and wrist

(or equivalent clothing), PVC or rubber apron, elbow length chemical resistant gloves.

If clothing becomes contaminated with product remove clothing immediately. If

product or drench on skin, immediately wash area with soap and water. After use

and before eating, drinking or smoking, wash hands, arms and face thoroughly with

soap and water. After each day's use wash gloves and contaminated clothing.

Additional informaton is listed in the Material Safety Data sheet

FIRST AID:

If swallowed, splashed on skin or in eyes, or inhaled, contact a Poisons

Information Centre Phone Australia 131126 or a doctor at once. Remove any

contaminated clothing and wash skin thoroughly. If swallowed, activated charcoal

may be advised. Give atropine if instructed.

DISPOSAL:

Thoroughly empty container into backpack. Triple or (preferably)

pressure rinse into the medicated drench container. DO NOT dispose of undiluted

chemicals on site. Return clean container for recycling where this is an option or for

disposal at a landfill authorised to accept that waste. If neither of these options are

available, bury the container below 500 mm in a disposal pit specifically marked and

set up for this purpose clear of waterways, vegetation and roots. Empty containers

should not be burned.

LIMITATION OF LIABILITY:

Bayer Australia Limited (BAL) warrants that this

product is of merchantable quality and fit for its intended purpose indicated on this

label. Failure to use the product strictly as directed may be illegal, prove dangerous

or render the product ineffective. Notwithstanding anything else contained on this

label, BAL’s liability is limited to replacing this product or supplying equivalent

product or paying the cost of replacing this product, at its discretion.

5L_Front (230 x 140mm)

Sheep Drench

Rametin

®

ACTIVE CONSTITUENT:

800 g/kg NAPHTHALOPHOS

(AN ANTICHOLINESTERASE COMPOUND)

For the control of organophosphate

susceptible strains of gastrointestinal

mature and immature roundworms in

sheep and lambs.

POISON

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

APVMA Approval No: 35800/1.5 kg/0710

Contents when packed

1.5 kg NET

Contents when reconstituted

10 Litres

170 mm

200 mm

35800_50159_10L_Immediate_MPL_V01

Date: 0710

Dimensions:170 x 200 mm

Scale: 100% when printed to 100% magnification on A3

RLP

APPROVED

0 000000 000000

POSITIONAL ONLY

Sheep Drench

Rametin

®

6 - 7.5

7.6 - 9

9.1 - 12

12.1 - 16

16.1 - 20

20.1 - 28

28.1 - 40

40.1 - 52

52.1 - 68

68.1 - 90

Bodyweight kg

Dose Volume

mL of prepared drench

2,500

2,000

1,666

1,250

1,000

Number of Sheep

treated per pack

RAMETIN

contains naphthalophos, a member of the organophosphorus family of

chemicals. It is effective against organophosphate susceptible strains of mature and

immature stages of Barber's Pole worm (Haemonchus contortus), Stomach Hair worm

(Trichostrongylus axei), Black Scour worm (Trichostrongylus spp.), Small Brown

Stomach worm (Ostertagia spp.), and mature stages of Thin Necked Intestinal worm

(Nematodirus spp.) in sheep and lambs.

RAMETIN

will control strains resistant to other drench groups but resistance may

develop to any drench product. Advice on internal parasite management to reduce

development of resistance should be obtained from your veterinary practitioner or animal

health consultant. It is advisable that a resistance test be conducted before any parasite

treatment is used. If drench failure is suspected, seek veterinary confirmation and notify

the manufacturer.

DIRECTIONS FOR USE:

RESTRAINTS:

DO NOT USE in female sheep which are producing, or may in the future produce, milk

or milk products for human consumption.

CONTRAINDICATIONS:

This product is contraindicated for use in severely debilitated, stressed or drought

affected animals or those affected by lupinosis.

This product is contraindicated for use in thirsty, exhausted sheep or those suffering

from poor nutrition.

This product is contraindicated for use in lambs less than 6 kg.

PRECAUTIONS:

Seek veterinary advice before administering at the same time as any other drench.

Allow animals access to water after treatment.

Use care when drenching. Avoid misdirecting dosage into the lungs.

Check the accuracy of the drench gun before starting to treat.

Ask your local veterinary practitioner or animal health advisor for recommended

parasite management practices for your area to reduce development of resistance.

DOSAGE AND ADMINISTRATION:

Remove large cap and half fill container slowly with water. Replace cap and shake well.

Then remove cap and top up with water to the fill line shown. Replace cap and shake

well for 3 minutes. RAMETIN

may be mixed with benzimidazole and levamisole based

drench product under veterinary advice. RAMETIN

Sheep Drench is compatible with

copper sulphate.

SAFETY DIRECTIONS: Very dangerous. Product and drench are poisonous if absorbed by

skin, inhaled or swallowed. May irritate the eyes and skin. Repeated exposure may cause

allergic disorders. Repeated minor exposure may have a cumulative poisoning effect.

Avoid contact with eyes and skin. Do not inhale dust. When opening the container and

preparing drench wear cotton overalls buttoned to the neck and wrist (or equivalent

clothing), PVC or rubber apron, elbow length chemical resistant gloves and a disposable

dust face mask covering mouth and nose. When using the prepared drench wear cotton

overalls buttoned to the neck and wrist (or equivalent clothing), PVC or rubber apron,

elbow length chemical resistant gloves. If clothing becomes contaminated with product

remove clothing immediately. If product or drench on skin, immediately wash area with

soap and water. After use and before eating, drinking or smoking, wash hands, arms and

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

contaminated clothing.

Additional informaton is listed in the Material Safety Data sheet.

FIRST AID: If swallowed, splashed on skin or in eyes, or inhaled, contact a Poisons

Information Centre Phone Australia 131126 or a doctor at once. Remove any

contaminated clothing and wash skin thoroughly. If swallowed, activated charcoal may

be advised. Give atropine if instructed.

DISPOSAL: Thoroughly empty container into backpack. Triple or (preferably) pressure

rinse into the medicated drench container.

DO NOT

dispose of undiluted chemicals on

site. Return clean container for recycling where this is an option or for disposal at a

landfill authorised to accept that waste. If neither of these options are available, bury the

container below 500 mm in a disposal pit specifically marked and set up for this purpose

clear of waterways, vegetation and roots. Empty containers should not be burned.

LIMITATION OF LIABILITY:

Bayer Australia Limited (BAL) warrants that this product is of

merchantable quality and fit for its intended purpose indicated on this label. Failure to

use the product strictly as directed may be illegal, prove dangerous or render the

product ineffective. Notwithstanding anything else contained on this label, BAL’s liability

is limited to replacing this product or supplying equivalent product or paying the cost of

replacing this product, at its discretion.

A representative sample of animals should be weighed before treatment.

Dose the mob to the heaviest animal by liveweight in each group (ewes, wethers,

rams, lambs).

Where there is a large variation in size within the group, dose rate should be based on

the label direction for each weight range. Drafting into two or more lines may be

appropriate, to avoid excessive overdosing.

WITHHOLDING PERIODS:

MEAT - DO NOT USE

less than 7 days before slaughter for human consumption.

MILK - DO NOT USE in female sheep which are producing, or may in the future

produce, milk or milk products for human consumption.

TRADE ADVICE:

EXPORT SLAUGHTER INTERVAL (ESI): DO NOT USE less than 7 days before slaughter

for export. The ESI on this label was correct at the time of label approval. Before using

this product, confirm the current ESI from the manufacturer on [Customer Information

Line 1800 678 368 Monday to Friday 9am to 4pm EST] or the APVMA website

(www.apvma.gov.au/residues/ESI.shtml).

MIXING INSTRUCTIONS: RAMETIN

mixes readily with all types of water.

Its high suspensibility ensures a consistent and uniform suspension during drenching. If

product is left standing, shake well before using. RAMETIN

Sheep Drench is stable

after mixing for up to 3 months when stored at 20°C.

UN No. 2783

1 800 033 111

Australia wide, 24 hours

emergency contact

Bayer Australia Limited

6

TOXIC

ORGANOPHOSPHORUS

PESTICIDES, LIQUID, TOXIC

APVMA Approval No: 35800/1.5 kg/0710

See container below for batch expiry date.

STORAGE: Store below 30°C (room temperature) in original container, tightly closed,

in a safe place. See drum for expiry date and batch number.

Bayer Australia Ltd. ACN 000 138 714

875 Pacific Highway, PYMBLE, NSW, 2073

RAMETIN

is a registered trademark of Bayer AG,

Leverkusen, Germany.

Manufactured in Australia

CUSTOMER INFORMATION LINE

1800 678 368

TOLL FREE from anywhere in Australia

9:00am to 4:00pm (Eastern Time) Monday to Friday

www.bayeranimal.com.au

170 mm

200 mm

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

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

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

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

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

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

Health Canada

9-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Donorweek 2018: Orgaandonor worden. Dat doe je voor elkaar

Donorweek 2018: Orgaandonor worden. Dat doe je voor elkaar

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

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

24-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

Rhino 8 Platinum 8000 capsules

Rhino 8 Platinum 8000 capsules

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

Therapeutic Goods Administration - Australia

27-7-2018

Pending EC decision:  Mekinist, trametinib, Opinion date: 26-Jul-2018

Pending EC decision: Mekinist, trametinib, Opinion date: 26-Jul-2018

Europe - EMA - European Medicines Agency

25-7-2018

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

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

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

FDA - U.S. Food and Drug Administration

21-6-2018

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

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

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

FDA - U.S. Food and Drug Administration

13-12-2018


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

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

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

Europe - EMA - European Medicines Agency

4-12-2018


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

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

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

Europe - EMA - European Medicines Agency

4-9-2018

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

Abseamed (Medice Arzneimittel PUtter GmbH and Co KG)

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

Europe -DG Health and Food Safety

29-8-2018

Mekinist (Novartis Europharm Limited)

Mekinist (Novartis Europharm Limited)

Mekinist (Active substance: trametinib) - Centralised - 2-Monthly update - Commission Decision (2018)5778 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2643/WS/1274

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