POOL CHLORINE

Main information

  • Trade name:
  • FREE STYLE PREMIUM POOL PRODUCTS POOL CHLORINE
  • Pharmaceutical form:
  • Granular
  • Units in package:
  • 2kg,4kg,10kg,15kg
  • Class:
  • AgChem
  • Medicine domain:
  • Equipment
  • Medicine type:
  • Agrochemical
  • Manufactured by:
  • POOL RESOURCES

Documents

Localization

  • Available in:
  • FREE STYLE PREMIUM POOL PRODUCTS POOL CHLORINE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • SWIMMING POOL
  • Therapeutic area:
  • bactericide,algaecide
  • Therapeutic indications:
  • ALGAE | BACTERIA
  • Product summary:
  • For control of bacteria and algae in swimming pools.DO NOT use this product in spa pool water. DO NOT use in a fixed or floating dispenser.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 30894/0507
  • Authorization date:
  • 15-08-2007
  • Last update:
  • 15-06-2017

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

File Name

Freestyle Granular_30894_2kg_Label_MPL_V02

Dimensions

114mm x 400mm

Scale

95% Scale on A3

Date

April 2007 V01

400mm

114mm

NET CONTENTS

2kg

ACTIVE CONSTITUENT: 700g/kg available CHLORINE (Cl)

present as CALCIUM HYPOCHLORITE, HYDRATED

FOR CONTROL OF

BACTERIA & ALGAE IN SWIMMING POOLS

ACTIVE CONSTITUENT: 700g/kg available CHLORINE (Cl)

present as CALCIUM HYPOCHLORITE, HYDRATED

FOR CONTROL OF

BACTERIA & ALGAE IN SWIMMING POOLS

POOL CHLORINE

POOL CHLORINE

POISON

KEEP OUT OF REACH OF CHILDREN

FIRE AND EXPLOSION HAZARD

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

NOT TO BE USED FOR ANY PURPOSE OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED

UNDER APPROPRIATE LEGISLATION

FREESTYLE™ POOL CHLORINE has been formulated to provide fast and effective sanitation

of your pool water. The fast dissolving granules make it ideal for routine chlorination since

it quickly destroys harmful germs, bacteria and contaminants leaving the water clear for

bather comfort and protection. Its consistently high quality, that is low in residue, ensures

crystal clear water quality.

GENERAL INSTRUCTIONS

Dissolve granules in water prior to dosing, or add directly to pool water.

The correct level of free chlorine should be maintained for several hours prior to and

during swimming activity.

Chlorine levels and pH should be tested daily by use of a reliable test kit using fresh

testing reagents.

If pH falls below the required level add Freestyle™ pH Buffer, if it rises above add

Freestyle™ Dry Acid.

Dose pool in the evening when the pool is not in use. Dosage rates indicated are only a

guide. Dose pool and then test to ensure the required free chlorine levels are reached.

If stabilizers are present in the pool, Stabilizer levels should be tested fortnightly

by your local pool shop or by use of a reliable test kit. If 50mg/l of stabilizer is

exceeded the ability of the chlorine to control algae and bacteria is reduced. UNDER

CIRCUMSTANCES

should

stabilizer

concentrations

allowed

exceed

100mg/L. If stabilizer concentration needs to be reduced consult your local pool shop.

SUPER-CHLORINATION

During the Summer season Super-Chlorinate once per week. After Super Chlorination,

the pH balance of your pool should be checked.

WINTER MAINTENANCE

A Super-Chlorination dose once a month is necessary to maintain your pool in good

condition during winter.

CAUTION: Not to be used as a food container.

WARNING

Highly reactive oxidizing chlorine compound. May cause fire or explosion. May produce

severe burns. Pruduct will irritate the eyes, nose, throat and skin.

SAFETY DIRECTIONS

Highly reactive oxidising chlorine compound. May cause fire and explosion or produce

severe burns. Product will irritate the eyes, nose, throat and skin. Avoid contact with the

eyes, skin and clothing. Do not inhale dust. DO NOT allow the product to come into

contact with other chemicals, especially acids, or with combustible material such as

paper, fabric, sawdust or kerosene. Do not allow to get damp. Use clean containers for

dispensing. DO NOT mix with other chemicals. DO NOT mix with different types of

chlorinating chemicals. Mix with water only. Do not add water to the product - add the

product to water, but in case of fire, drench with water. Store undercover in a dry, clean,

cool, well ventilated place away from sunlight. Store and transport in an upright

container. In case of spillage, flush with large quantities of water. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information Centre (phone Australia 13

1126; New Zealand 0800 764 766). If swallowed, DO NOT induce vomiting. Give a

glass of water. If skin contact occurs, remove contaminated clothing and wash skin

thoroughly. If in eyes, hold eyes open, flood with water for at least 15 minutes and see

a doctor.

WATERCO LIMITED

ABN 62 002 070 733

390 Marion Street Bankstown

NSW 2200 Australia

Ph: (02) 9795 5500

Cat. No. 1001602/H05

APVMA Approval no.30894/2kg/0507

D.O.M. B.N.

9 310210 104001

POSITIONAL ONLY

CALCIUM HYPOCHLORITE

HYDRATED, UN No. 2880

PG II, HAZCHEM 2W

IN A TRANSPORT EMERGENCY

DIAL 000 (POLICE OR FIRE BRIGADE)

* Contains chlorine stabiliser, such as cyanuric acid.

These dosage rates are only a guide to assist in achieving the required levels of free chlorine.

POOL VOLUME,

LITRES

10,000

INITIAL START UP

SHOCK TREATMENT

SUPER CHLORINATION

*STABILIZED POOLS

DAILY CHLORINE DOSAGE

7 x Daily Dosage

4 x Daily Dosage

FREE CHLORINE

CONCENTRATION

Refer to Required

Levels Table

10 - 15 mg/L

10 mg/L

UNSTABILIZED POOLS

DAILY CHLORINE DOSAGE

4 x Daily Dosage

2 x Daily Dosage

TYPE

OF POOL

UNSTABILIZED

STABILIZED

LEVEL OF STABILIZER

(mg/L)

30-50#

(optimum range)

TOTAL ALKALINITY

(mg/L)

60-200

60-200

MINIMUM FREE CHLORINE

LEVEL (mg/L)

Cold Water

1.0 Indoor Pool

2.0 Outdoor Pool

Above 26˚C

# Do not exceed a concentration of 100mg/L of isocyanurate.

FREESTYLE

POOL CHLORINE

DIRECTIONS FOR USE

RESTRAINTS:

DO NOT use this product in spa pool water.

DO NOT use in a fixed or floating dispenser.

REQUIRED LEVELS

APPROVED

LABEL

Info

pest

Verified

Info

pest

Verified

373mm

144mm

File Name

Freestyle Granular_30894_4kg_Label_MPL_V02

Dimensions

144mm x 373mm

Scale

100% Scale on A3

Date

April 2007 V01

* These dosage rates are for stabilized and unstabilized pools.

These dasage rates are only a guide to assist in achieving the required levels of free chlorine.

POOL VOLUME,

LITRES

10,000

INITIAL START UP

SHOCK TREATMENT

SUPER-

CHLORINATION

*STABILIZED POOLS

DAILY CHLORINE DOSAGE

7 x Daily Dosage

4 x Daily Dosage

FREE CHLORINE

CONCENTRATION

Refer to Required

Levels Table

10 - 15 mg/L

10 mg/L

UNSTABILIZED POOLS

DAILY CHLORINE DOSAGE

4 x Daily Dosage

2 x Daily Dosage

TYPE

OF POOL

UNSTABILIZED

STABILIZED

LEVEL OF STABILIZER

(mg/L)

30-50#

(optimum range)

TOTAL ALKALINITY

(mg/L)

60-200

60-200

MINIMUM FREE CHLORINE

LEVEL (mg/L)

Cold Water

1.0 Indoor Pool

2.0 Outdoor Pool

Above 26˚C

# Do not exceed a concentration of 100mg/L of isocyanurate.

9 310210 104049

POSITIONAL ONLY

FREESTYLE

POOL CHLORINE

DIRECTIONS FOR USE

RESTRAINTS:

DO NOT use this product in spa pool water.

DO NOT use in a fixed or floating dispenser.

REQUIRED LEVELS

NOT TO BE USED FOR ANY PURPOSE OR IN ANY MANNER CONTRARY TO THIS LABEL UNLESS AUTHORISED

UNDER APPROPRIATE LEGISLATION

FREESTYLE™ POOL CHLORINE has been formulated to provide fast and effective

sanitation of your pool water. The fast dissolving granules make it ideal for routine

chlorination since it quickly destroys harmful germs, bacteria and contaminants leaving

the water clear for bather comfort and protection. Its consistently high quality, that is low

in residue, ensures crystal clear water quality.

GENERAL INSTRUCTIONS

Dissolve granules in water prior to dosing, or add directly to pool water.

The correct level of free chlorine should be maintained for several hours prior to and

during swimming activity.

Chlorine levels and pH should be tested daily by use of a reliable test kit using

fresh testing reagents.

If pH falls below the required level add Freestyle™ pH Buffer, if it rises above add

Freestyle™ Dry Acid.

Dose pool in the evening when the pool is not in use. Dosage rates indicated are only

a guide. Dose pool and then test to ensure the required free chlorine levels are reached.

If stabilizers are present in the pool, Stabilizer levels should be tested fortnightly

by your local pool shop or by use of a reliable test kit. If 50mg/l of stabilizer is

exceeded the ability of the chlorine to control algae and bacteria is reduced. UNDER

CIRCUMSTANCES

should

stabilizer

concentrations

allowed

exceed

100mg/L. If stabilizer concentration needs to be reduced consult your local pool shop.

SUPER-CHLORINATION

During the Summer season Super-Chlorinate once per week. After Super Chlorination, the

pH balance of your pool should be checked.

WINTER MAINTENANCE

A Super-Chlorination dose once a month is necessary to maintain your pool in good

condition during winter.

CAUTION: Not to be used as a food container.

WARNING: Highly reactive oxidizing chlorine compound. May cause fire or explosion.

May produce severe burns. Pruduct will irritate the eyes, nose, throat and skin.

SAFETY DIRECTIONS: Avoid contact with eyes. Avoid contact with skin. Avoid contact with

clothing. Avoid breathing dust. Do not allow product to come into contact with other

chemicals, especially acids. Do not allow product to come into contact with combustible

materials such as paper, fabric, sawdust or kerosene. Do not allow to get damp. Use clean

containers for dispensing. Do not mix with other chemicals. Do not mix with different types

of chlorinating chemicals. Mix with water only. Do not add water to product - add product

to water, but in case of fire, drench with water. Store undercover in a dry, clean, cool, well

ventilated place away from sunlight. Store and transport in an upright container. In case of

spillage, flush with large quantities of water.

FIRST AID:

For advice, contact a Poisons Information Centre (Phone eg Australia 131126; New

Zealand 0800 764 766) or a doctor (at once). If swallowed, DO NOT induce vomiting. If

in eyes, hold eyelids apart and flush the eye continuously with running water. Continue

flushing until advised to stop by the Poisons Information Centre or a doctor, or for at least

15 minutes. If skin or hair contact occurs, remove contaminated clothing and flush skin and

hair with running water.

WATERCO LIMITED

ABN 62 002 070 733

390 Marion Street Bankstown

NSW 2200 Australia

Ph: (02) 9795 5500

Cat. No. 1001404/G03

APVMA Approval no. 30894/4kg/0507

D.O.M. B.N.

CALCIUM HYPOCHLORITE

HYDRATED, UN No. 2880

PG II, HAZCHEM 2W

IN A TRANSPORT EMERGENCY

DIAL 000 (POLICE OR FIRE BRIGADE)

NET CONTENTS

4kg

ACTIVE CONSTITUENT: 700g/kg available CHLORINE (Cl)

present as CALCIUM HYPOCHLORITE, HYDRATED

FOR CONTROL OF

BACTERIA & ALGAE IN SWIMMING POOLS

ACTIVE CONSTITUENT: 700g/kg available CHLORINE (Cl)

present as CALCIUM HYPOCHLORITE, HYDRATED

FOR CONTROL OF

BACTERIA & ALGAE IN SWIMMING POOLS

POOL CHLORINE

POOL CHLORINE

POISON

KEEP OUT OF REACH OF CHILDREN

FIRE AND EXPLOSION HAZARD

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

APPROVED

LABEL

File Name

Freestyle Granular_30894_10kg_Front_MPL_V02

Dimensions

210mm x 160mm

Scale

100% Scale on A4

Date

April 2007 V01

NET CONTENTS

10kg

ACTIVE CONSTITUENT: 700g/kg available CHLORINE (Cl)

present as CALCIUM HYPOCHLORITE, HYDRATED

FOR CONTROL OF

BACTERIA & ALGAE IN SWIMMING POOLS

ACTIVE CONSTITUENT: 700g/kg available CHLORINE (Cl)

present as CALCIUM HYPOCHLORITE, HYDRATED

FOR CONTROL OF

BACTERIA & ALGAE IN SWIMMING POOLS

POISON

KEEP OUT OF REACH OF CHILDREN

FIRE AND EXPLOSION HAZARD

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

160mm

210mm

150mm

APPROVED

LABEL

File Name

Freestyle Granular_30894_10kg_Back_MPL_V02

Dimensions

210mm x 160mm

Scale

100% Scale on A4

Date

April 2007 V01

160mm

210mm

150mm

TYPE

POOL

UNSTABILIZED

STABILIZED

LEVEL OF

STABILIZER

(mg/L)

30-50#

(optimum

range)

TOTAL

ALKALINITY

(mg/L)

60-200

60-200

MINIMUM FREE

CHLORINE LEVEL(mg/L)

Cold Water

1.0 Indoor Pool

2.0 Indoor Pool

Above 26˚C

# Do not exceed a concentration of 100mg/L of isocyanurate.

POSITIONAL ONLY

WATERCO LIMITED

ABN 62 002 070 733

390 Marion Street Bankstown

NSW 2200 Australia

Ph: (02) 9795 5500

Cat. No. 1001110/J05

APVMA Approval no. 30894/10kg/0507

D.O.M. B.N.

CALCIUM HYPOCHLORITE

HYDRATED, UN No. 2880

PG II, HAZCHEM 2W

IN A TRANSPORT EMERGENCY

DIAL 000 (POLICE OR FIRE BRIGADE)

POOL

VOLUME,

LITRES

10,000

INITIAL START UP

SHOCK TREATMENT

SUPER

CHLORINATION

*STABILIZED POOLS

DAILY CHLORINE

DOSAGE

7 x Daily Dosage

4 x Daily Dosage

*UNSTABILIZED POOLS

DAILY CHLORINE

DOSAGE

4 x Daily Dosage

2 x Daily Dosage

FREE

CHLORINE

CONCENTRATION

Refer to Required

Levels Table

10-15mg/L

10mg/L

FREESTYLE

POOL CHLORINE

DIRECTIONS FOR USE

RESTRAINTS:

DO NOT use this product in spa pool water.

DO NOT use in a fixed or floating dispenser.

* Contains chlorine stabilizer, such as cyanuric acid .

These dasage rates are only a guide to assist in achieving the required

levels of free chlorine.

REQUIRED LEVELS:

NOT TO BE USED FOR ANY PURPOSE OR IN ANY MANNER

CONTRARY TO THIS LABEL UNLESS AUTHORISED UNDER

APPROPRIATE LEGISLATION

FREESTYLE™ POOL CHLORINE has been formulated to provide fast and effective

sanitation of your pool water. The fast dissolving granules make it ideal for

routine chlorination since it quickly destroys harmful germs, bacteria and

contaminants leaving the water clear for bather comfort and protection. Its

consistently high quality, that is low in residue, ensures crystal clear water quality.

GENERAL INSTRUCTIONS

Dissolve granules in water prior to dosing, or add directly to pool water.

The correct level of free chlorine should be maintained for several hours

prior to and during swimming activity.

Chlorine levels and pH should be tested daily by use of a reliable test kit

using fresh testing reagents.

If pH falls below the required level add Freestyle pH Buffer, if it rises above

add Freestyle Dry Acid.

Dose pool in the evening when the pool is not in use. Dosage rates indicated

are only a guide. Dose pool and then test to ensure the required free chlorine

levels are reached.

If stabilizers are present in the pool, Stabilizer levels should be tested

fortnightly by your local pool shop or by use of a reliable test kit. If 50mg/L of

stabilizer is exceeded the ability of the chlorine to control algae and bacteria

is reduced. UNDER NO CIRCUMSTANCES should stabilizer concentrations

be allowed to exceed 100mg/L. If stabilizer concentrations needs to be

reduced consult your local pool shop.

SUPER-CHLORINATION

During the Summer season Super-Chlorinate once per week. After Super-

Chlorination, the pH balance of your pool should be checked.

WINTER MAINTENANCE

A Super-Chlorination dose once a month is necessary to maintain your pool in

good condition during winter.

CAUTION: Not to be used as a food container.

S

AFETY DIRECTIONS

Highly reactive oxidising chlorine compound. May cause fire and

explosion or produce severe burns. Product will irritate the eyes,

nose, throat and skin. Avoid contact with the eyes, skin and

clothing. Do not inhale dust. DO NOT allow the product to come

into

contact

with

other

chemicals,

especially

acids,

with

combustible material such as paper, fabric, sawdust or kerosene.

Do not allow to get damp. Use clean containers for dispensing.

DO NOT mix with other chemicals. DO NOT mix with different

types of chlorinating chemicals. Mix with water only. Do not add

water to the product - add the product to water, but in case of fire,

drench with water. Store undercover in a dry, clean, cool, well

ventilated place away from sunlight. Store and transport in an

upright container. In case of spillage, flush with large quantities

of water. Wash hands after use.

FIRST AID

If poisoning occurs contact a doctor or Poisons Information

Centre (Phone eg Australia 131126; New Zealand 0800 764

766). If swallowed, DO NOT induce vomiting. If skin or hair

contact occurs, remove contaminated clothing and flush skin and

hair with running water. If in eyes, hold eyelids apart and flush

the eye continuously with running water for at least 15 minutes

and see a doctor.

APPROVED

LABEL

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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

18-12-2018

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

Atherstone Foods Inc Issues Allergy Alert on Undeclared Soy in “Greens and Grains Hummus and Quinoa Tabouleh Wrap”

ATHERSTONE FOODS INC of Richmond, CA is recalling 14.6 ounce (414g) Greens and Grains Hummus and Quinoa Tabouleh Wrap, because it may contain undeclared soy, people who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

17-12-2018

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Blokhuis stelt prioriteiten van actieprogramma Zwerfjongeren vast

Een betaalbare woonplek, voldoende kansen op een opleiding en een baan, financiële zelfredzaamheid en voldoende zorg en ondersteuning. Basisbehoeften voor ieder mens, maar waaraan de 10.700 zwerfjongeren (18 – 27 jaar) in Nederland nog te vaak tekortkomen. Op die vier ‘levensbrede’ prioriteiten zal de staatssecretaris zich richten met zijn actieprogramma Zwerfjongeren, dat hij afgelopen oktober in Tweede Kamer aankondigde. Met het actieprogramma brengt hij lokale partijen en gemeenten, maar ook andere ve...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

14-11-2018

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The chocolate bars can be enjoyed if you do not have milk allergies or sensitivities. Recchiuti Confections is...

FDA - U.S. Food and Drug Administration

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

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

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

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

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

13-9-2018

Sarap Asian Fusion Recalls Cookies due to Undeclared Allergens

Sarap Asian Fusion Recalls Cookies due to Undeclared Allergens

Sarap Asian Fusion of Garden Grove, CA is recalling Asian Fusion Cookies due to undeclared allergens of wheat, milk and soy. People who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

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

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

22-11-2018

Pelmeg (Cinfa Biotech S.L.)

Pelmeg (Cinfa Biotech S.L.)

Pelmeg (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)7894 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4700

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (MaaT PHARMA)

EU/3/18/2083 (Active substance: Allogeneic faecal microbiota, pooled) - Orphan designation - Commission Decision (2018)7792 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/123/18

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

28-8-2018

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Pfizer Europe MA EEIG)

LIFMIOR (Active substance: etanercept) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5700 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4167T/17

Europe -DG Health and Food Safety