Pharmasin

Main information

  • Trade name:
  • Pharmasin 200 mg/ml Solution for Injection for Cattle, Sheep,Goats and Swine
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Pharmasin 200 mg/ml Solution for Injection for Cattle, Sheep,Goats and Swine
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • tylosin
  • Therapeutic area:
  • Cattle, Goats, Pigs, Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0239/001
  • Authorization date:
  • 21-12-2012
  • EU code:
  • FR/V/0239/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

[Version7.3.2,10/2011]

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Apaleyellowtoamber-colouredliquid.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,sheep,goats,pigs.

4.2 Indicationsforuse(specifyingthetargetspecies)

Infectionscausedmymicroorganismssusceptibletotylosin.

Cattle(adult):

- Treatmentofrespiratoryinfections,metritiscausedbyGram-positive

micro-organisms,mastitiscausedbyStreptococcusspp.,Staphylococcusspp.

orMycoplasmaandinterdigitalnecrobacillosis”,i.e.panaritumorfootrot.

Calves:

- Treatmentofrespiratoryinfectionsandnecrobacillosis.

Pigs:

- Treatmentofenzooticpneumonia,haemorrhagicenteritis,erysipelasand

metritis.

- TreatmentofarthritiscausedbyMycoplasmaandStaphylococcusspp.

Sheepandgoats:

Treatmentofrespiratoryinfections,metritiscausedbyGram-positive

microorganisms,mastitiscausedbyGram+microorganismsorMycoplasmaspp.

4.3 Contraindications

Donotadministertohorses.Intramuscularinjectioncanbefatalinchickensand

turkeys.

Donotadministertoanimalswithaknownhypersensitivitytotylosinorother

macrolides.

4.4 Specialwarnings(foreachtargetspecies)

None.

4.5 Specialprecautionsforuse

4.5i) Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriato

tylosin,bacteriologicalsamplingandsusceptibilitytestingare

recommended.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmay

increasetheprevalenceofbacteriaresistanttotylosinandmaydecreasethe

effectivenessoftreatmentwithothermacrolideantibioticsduetothe

potentialforcrossresistance

Whererepeatinjectionsaretobeadministered,usedifferentsitesforeach

injection.

4.5ii) Specialprecautionsforthepersonadministeringtheveterinary

medicinalproducttoanimals

Careshouldbetakentoavoidaccidentalself-injection.

Ifaccidentalself-injectionoccurs,seekmedicalattentionimmediately.

Intheeventofaccidentalskincontact,washthoroughlywithsoapand

water.Incaseofaccidentaleyecontact,flushtheeyeswithplentyofclean,

runningwater.

Washhandsafteruse.

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocause

hypersensitivity(allergy)followinginjection,inhalation,ingestionor

contactwithskinoreye.Hypersensitivitytotylosinmayleadtocross

reactionstoothermacrolidesandviceversa.Allergicreactionstothese

substancesmayoccasionallybeseriousandthereforedirectcontactshould

beavoided.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshould

seekmedicaladviceandshowthephysicianthiswarning.Swellingofthe

face,lipsandeyesordifficultyinbreathingaremoreserioussymptomsand

requireurgentmedicalattention.

4.6 Adversereactions(frequencyandseriousness)

Blemishesmayoccuratthesiteofinjectionandcanpersistforupto21days

followingadministration.

Possibleadversereactionsattributedtotheproductwhenusedasrecommended

andtheirfrequencyare:Inveryrarecasesthefollowinghavebeenobserved;

swelling/inflammationatthesiteofinjection,vulvularswellingincattle,oedema

oftherectalmucosa,partialanalprotrusion(‘rosebudding’),erythemaand

pruritusinpigs.Anaphylacticshockanddeath.

4.7 Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic,

foetotoxicormaternotoxiceffects.Nostudieshavebeenconductedinthetarget

species.Useonlyaccordingtothebenefit/riskassessmentbytheresponsible

veterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9 Amount(s)tobeadministeredandadministrationroute

Intramuscularorslowintravenousinjection(onlyincattle)

Cattle:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionfor

injectionper100kgbodyweight)Maximuminjectionvolumeperinjectionsite

shouldnotexceed15ml.

Sheepandgoats:

10mgtylosin/kgbodyweightperdayduring3days(5mlsolutionforinjection

per100kgbodyweight)

Pigs:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionfor

injectionper100kgbodyweight)

Theclosuresshouldnotbebroachedmorethan15times.Inordertoprevent

excessivebroachingofthestopper,asuitablemultipledosingdeviceshouldbe

used.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyas

possibletoavoidunderdosing.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inpigsandcalvesanintramuscularinjectionof30mg/kgperdayduring5

consecutive

daysproducednoadverseeffects.

4.11 Withdrawalperiod(s)

Cattle

Meatandoffal:28days.

Milk:108hours.

Sheepandgoats:

Meatandoffal:42days.

Milk:108hours

Pigs:

Meatandoffal:14days.

5. PHARMACOLOGICALORIMMUNOLOGICALPROPERTIES

ATCVetCode:

Pharmacotherapeuticgroup:Antibacterialsforsystemicuse,macrolides,tylosin

ATCvetcode:QJ01FA90

5.1 Pharmacodynamicproperties

TylosinisamacrolideantibioticwithapKaof7.1.Tylosinisstructurallysimilarto

erythromycin.ItisproducedbyStreptomycesfradiae.Tylosinhasalowsolublilityin

water.Tylosinexertsitsantibioticactivitybyasimilarmechanismtoother

macrolides,i.e.bybindingthe50Sfractionoftheribosomesresulting,inan

inhibitionofthesynthesisofproteins.Tylosinhasmainlyabacteriostaticactivity.

TylosinhasanantibioticeffectagainstGrampositivecocci(Staphylococci,

Streptococci),Grampositivebacilli(Arcanobacteriumspp.,Clostridiumspp.,

Erysipelothrix,Actinomyces),certainGram-negativebacilles(Haemophilusspp.,

Pasteurellaspp.,Mannheimiaspp.)andMycoplasma.Theantibioticspectrumof

tylosincoversthemajorityofmicroorganismresponsibleforprimaryinfectionsin

younglivestock.

5.2 Pharmacokineticproperties

Absorption:

Followingintramuscularinjectionthetylosinconcentrationreachesitsmaximum

at3-4hoursfollowingadministration.

Distribution:

Themaximumconcentrationinmilkofcattleandsowsis3-6timeshigherthanthe

bloodconcentrationabout6hoursfollowinginjection.Inbovineandporcinelungs

maximumtylosinconcentrationsof7-8timeshigherthanthemaximum

concentrationsinserumwerefoundat6-24hoursfollowingintramuscular

injection.Incattle(whetherinheatornot)theMeanResidenceTime(MRT)in

uterussecretionsoftylosininjectedbyintravenousrouteatadoserateof10

mg/kgwasabout6-7timeshigherthantheonemeasuredinserum.This

illustratesthatinuterinesecretionsasingletylosininjectionatadoserateof10

mg/kgduring24hourscanresultinconcentrationsexceedingtheMIC

oftylosinforArcanobacteriumpyogenes,oneofthepathogensfrequentlyisolated

whenmetritisisdiagnosedincattle.

Elimination:

Tylosiniseliminatedinunchangedforminbileandurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Benzylalcohol(E1519)

Propyleneglycol

Waterforinjections

6.2 Incompatibilities

Inabsenceofcompatibilitystudiesthisveterinaryproductmustnotbemixedwith

otherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months.

Shelflifeafterfirstopeningoftheimmediatepackaging:28days.Discardany

productremaininginthecontaineratthistime.

6.4 Specialprecautionsforstorage

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25°C.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Theproductispresentedin50ml,100mlor250mlTypeIIcolourlessglassvials,

sealedwithabromobutylstopperandaluminiumcapsuppliedinacarton.One

vialpercarton.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7.1 MARKETINGAUTHORISATIONHOLDER

HuvepharmaN.V.

Uitbreidingsstraat80

2600Antwerpen

Belgium

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

ANNEXIII

LABELLINGANDPACKAGELEAFLET

A.LABELLING

PARTICULARSTOAPPEARONTHEOUTERPACKAGE

50/100/250mlglassvial

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs

Tylosin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

50(100and250ml)

5. TARGETSPECIES

Cattle,sheep,goats,pigs.

6. INDICATION(S)

Readthepackageleafletbeforeuse

7. METHODANDROUTE(S)OFADMINISTRATION

Forintramuscularorintravenous(cattleonly)use

Readthepackageleafletbeforeuse

8. WITHDRAWALPERIOD

Meatandoffal:

Cattle:28days

Sheepandgoats:42days

Pigs:14days

Milk:108hours

9. SPECIALWARNING(S),IFNECESSARY

Seepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Oncebroachedusewithin28days.Discardanyproductremaininginthecontaineratthis

time.

Onceopened,useby

11.SPECIALSTORAGECONDITIONS

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25 C.Donot

freeze.

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Seepackageleaflet.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

Tel:+3232881849

Fax:+3232897845

E-mail: customerservice@huvepharma.com

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

PARTICULARSTOAPPEARONTHEIMMEDIATEPACKAGE

50/100/250mlglassvial

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs

Tylosin

2. STATEMENTOFACTIVEANDOTHERSUBSTANCES

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

3. PHARMACEUTICALFORM

Solutionforinjection.

4. PACKAGESIZE

50(100and250ml)

5. TARGETSPECIES

Cattle,sheep,goats,pigs.

6. INDICATION(S)

Readthepackageleafletbeforeuse

7. METHODANDROUTE(S)OFADMINISTRATION

Forintramuscularorintravenous(cattleonly)use

Readthepackageleafletbeforeuse

8. WITHDRAWALPERIOD

Meatandoffal:

Cattle:28days

Sheepandgoats:42days

Pigs:14days

Milk:108hours

9. SPECIALWARNING(S),IFNECESSARY

Seepackageleafletbeforeuse.

10.EXPIRYDATE

EXP{month/year}

Oncebroachedusewithin28days.Discardanyproductremaininginthecontaineratthis

time.

Onceopened,useby

11.SPECIALSTORAGECONDITIONS

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25 C.Donotfreeze

12.SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTSOR

WASTEMATERIALS,IFANY

Seepackageleaflet.

13.THEWORDS“FORANIMALTREATMENTONLY”ANDCONDITIONSOR

RESTRICTIONSREGARDINGSUPPLYANDUSE,ifapplicable

Foranimaltreatmentonly.Tobesuppliedonlyonveterinaryprescription.

14.THEWORDS“KEEPOUTOFTHEREACHANDSIGHTOFCHILDREN”

Keepoutofthereachandsightofchildren.

15.NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

HuvepharmaNV

Uitbreidingstraat80

2600Antwerpen

Belgium

Tel:+3232881849

Fax:+3232897845

E-mail: customerservice@huvepharma.com

16.MARKETINGAUTHORISATIONNUMBER(S)

17.MANUFACTURER’SBATCHNUMBER

<Batch><Lot><BN>{number}

B.PACKAGELEAFLET

PACKAGELEAFLET

PHARMASIN200mg/mlSolutionforInjectionforcattle,sheep,goatsandpigs

tylosin

1. NAMEANDADDRESSOFTHEMARKETINGAUTHORISATIONHOLDER

AND OF THE MANUFACTURING AUTHORISATION HOLDER

RESPONSIBLEFORBATCHRELEASE,IFDIFFERENT

Marketingauthorisationholder

HuvepharmaNV,Uitbreidingstraat80,2600Antwerpen,Belgium

Manufacturer

BiovetJSC,39PetarRakovStr,4550Peshtera-Bulgaria

2. NAMEOFTHEVETERINARYMEDICINALPRODUCT

PHARMASIN200mg/mlsolutionforinjectionforcattle,sheep,goatsandpigs.

tylosin

3. STATEMENT OF THE ACTIVESUBSTANCE(S)ANDOTHER

INGREDIENT(S)

Activesubstance:

Tylosin200000IU/ml

Excipients:

Benzylalcohol(E1519) 40mg/ml.

Apaleyellowtoamber-colouredliquid.

4. INDICATION(S)

Infectionscausedbymicroorganismssusceptibletotylosin.

Cattle(adult):

- Treatmentofrespiratoryinfections,metritiscausedbyGram-positivemicro-

organisms,mastitiscausedbyStreptococcusspp.,Staphylococcusspp.orMycoplasma

andinterdigitalnecrobacillosis”,i.e.panaritumorfootrot..

Calves:

- Treatmentofrespiratoryinfectionsandnecrobacillosis.

Pigs:

- Treatmentofenzooticpneumonia,haemorrhagicenteritis,erysipelasandmetritis.

- TreatmentofarthritiscausedbyMycoplasmaandStaphylococcusspp.

Sheepandgoats:

- Treatmentofrespiratoryinfections,metritiscausedbyGram-positive

microorganisms,mastitiscausedbyGram+microorganismsorMycoplasmaspp.

5. CONTRAINDICATIONS

Donotadministertohorses.Intramuscularinjectioncanbefatalinchickensandturkeys.

Donotadministertoanimalswithaknownhypersensitivitytotylosinorothermacrolides.

6. ADVERSEREACTIONS

Blemishesmayoccuratthesiteofinjectionandcanpersistforupto21daysfollowing

administration.

Possibleadversereactionsattributedtotheproductwhenusedasrecommendedandtheir

frequencyare:Inveryrarecasesthefollowinghavebeenobserved;swelling/inflammation

atthesiteofinjection,vulvularswellingincattle,oedemaoftherectalmucosa,partialanal

protrusion(‘rosebudding’),erythemaandpruritusinpigs.Anaphylacticshockanddeath.

7. TARGETSPECIES

Cattle,sheep,goats,pigs.

8. DOSAGE FOR EACH SPECIES, ROUTE(S)ANDMETHODOF

ADMINISTRATION

Amount(s)tobeadministeredandadministrationroute

Intramuscularorslowintravenousinjection(onlyincattle)

Cattle:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionforinjection

per100kgbodyweight.Maximuminjectionvolumeperinjectionsiteshouldnotexceed15

ml.

Sheepandgoats:

10mgtylosin/kgbodyweightperdayduring3days(5mlsolutionforinjectionper100kg

bodyweight.

Pigs:

5-10mgtylosin/kgbodyweightperdayduring3days(2,5to5mlsolutionforinjection

per100kgbodyweight.

Toensureacorrectdosage,bodyweightshouldbedeterminedasaccuratelyaspossibleto

avoidunderdosing.

9. ADVICEONCORRECTADMINISTRATION

Theclosuresshouldnotbebroachedmorethan15times.Inordertopreventexcessive

broachingofthestopper,asuitablemultipledosingdeviceshouldbeused.

10. WITHDRAWALPERIOD

Cattle:

Meatandoffal:28days.

Milk:108hours.

Sheepandgoats:

Meatandoffal:42days.

Milk:108hours

Pigs:

Meatandoffal:14days.

11. SPECIALSTORAGEPRECAUTIONS

Keepoutofthereachandsightofchildren.

Shelflifeafterfirstopeningtheimmediatepackaging:28days.Discardanyproduct

remaininginthecontaineratthistime

Protectfromlight.Storeintheoriginalcontainer.Donotstoreabove25°C.Donotfreeze.

Donotuseaftertheexpirydatestatedonthelabel.

12. SPECIALWARNING(S)

None.

Specialprecautionsforuseinanimals

Duetolikelyvariability(time,geographical)insusceptibilityofbacteriatotylosin,

bacteriologicalsamplingandsusceptibilitytestingarerecommended.

UseoftheproductdeviatingfromtheinstructionsgivenintheSPCmayincreasethe

prevalenceofbacteriaresistanttotylosinandmaydecreasetheeffectivenessoftreatment

withothermacrolideantibioticsduetothepotentialforcrossresistance

Whererepeatinjectionsaretobeadministered,usedifferentsitesforeachinjection.

Specialprecautionsforthepersonadministeringtheveterinarymedicinalproductto

animals

Careshouldbetakentoavoidaccidentalself-injection.

Ifaccidentalself-injectionoccurs,seekmedicalattentionimmediately.

Intheeventofaccidentalskincontact,washthoroughlywithsoapandwater.Incaseof

accidentaleyecontact,flushtheeyeswithplentyofclean,runningwater.

Washhandsafteruse.

Tylosinmayinduceirritation.Macrolides,suchastylosin,mayalsocausehypersensitivity

(allergy)followinginjection,inhalation,ingestionorcontactwithskinoreye.

Hypersensitivitytotylosinmayleadtocrossreactionstoothermacrolidesandviceversa.

Allergicreactionstothesesubstancesmayoccasionallybeseriousandthereforedirect

contactshouldbeavoided.

Donothandletheproductifyouareallergictoingredientsintheproduct.

Ifyoudevelopsymptomsfollowingexposure,suchasskinrash,youshouldseekmedical

adviceandshowthephysicianthiswarning.Swellingoftheface,lipsandeyesor

difficultyinbreathingaremoreserioussymptomsandrequireurgentmedicalattention.

Useduringpregnancy,lactationorlay

Studiesinlaboratoryanimalshavenotproducedanyevidenceofteratogenic,foetotoxicor

maternotoxiceffects.Nostudieshavebeenconductedinthetargetspecies.Useonly

accordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inpigsandcalvesanintramuscularinjectionof30mg/kgperdayduring5consecutive

daysproducednoadverseeffects.

Incompatibilities

Inabsenceofcompatibilitystudiesthisveterinaryproductcannotbemixedwithother

veterinarymedicinalproducts.

13. SPECIALPRECAUTIONSFORTHEDISPOSALOFUNUSEDPRODUCTOR

WASTEMATERIALS,IFANY

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

14. DATEONWHICHTHEPACKAGELEAFLETWASLASTAPPROVED

15. OTHERINFORMATION

Theproductispresentedin50,100or250mlTypeIIcolourlessglassvials,sealedwitha

bromobutylstopperandaluminiumcapsuppliedinacarton.Onevialpercarton.

Notallpacksizesmaybemarketed.

Foranyinformationaboutthisveterinarymedicinalproduct,pleasecontactthelocal

representativeofthemarketingauthorisationholder.

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Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 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 Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

Published on: Thu, 15 Nov 2018 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for pyraclostrobin in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residues trials supporting the existing use of pyraclostrobin on table grapes authorised in southern EU Member States and an analytical method for analysing residues of pyraclostrobin in ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

The recalled products are not provided with the required child-resistant containers required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

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

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

The recalled products do not have proper hazard labelling required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

23-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Evaluation of confirmatory data following the Article 12 MRL review for pendimethalin

Published on: Mon, 22 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in the Netherlands to evaluate the confirmatory data that were identified in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, residue trials on strawberries, onions, garlic, tomatoes, peppers, cucumbers, artichokes, leeks and rape seeds were submitted. The data gaps are considere...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Evaluation of confirmatory data following the Article 12 MRL review for pyraflufen‐ethyl

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant, Nichino Europe Co. Ltd., submitted application request to the competent national authority in the Netherlands to evaluate confirmatory data that were identified for pyraflufen‐ethyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted data were sufficient to confirm the MRLs for citrus fruits, tree nuts, pome fruits, stone fruits, table and wine grapes, curra...

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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

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

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

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

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

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

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

Osmo Wood and Colour Canada Ltd. recalls Various Wood Finishing Products

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

26-11-2018

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient

Today’s statement highlights increased expectations for information required in 510(k) submissions; each averages 1,185 pages, compared to 475 pages in 2009. Reviewers spend more time reviewing applications, but time to decision has become more efficient https://go.usa.gov/xPHdE 

FDA - U.S. Food and Drug Administration

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency