مليىان

المعلومات الرئيسية

  • اسم تجاري:
  • مليىان
  • الشكل الصيدلاني:
  • COATED TABLETS
  • طريقة التعاطي:
  • PER OS
  • يسخدم من اجل:
  • البشر
  • نوع الدواء:
  • المخدرات الوباتشيك
  • المصنعة من قبل:
  • DELPHARM LILLE, SAS, FRANCE

المستندات

الأقلمة

  • متاح في:
  • مليىان
    إسرائيل
  • اللغة:
  • العربية

معلومات العلاجية

  • المجموعة العلاجية:
  • GESTODENE AND ESTROGEN
  • الخصائص العلاجية:
  • Oral contraceptive.

معلومات أخرى

الحالة

  • المصدر:
  • Ministry of Health - State of Israel
  • تخويل:
  • 109122909400
  • تاريخ الترخيص:
  • 01-01-2013
  • اخر تحديث:
  • 09-08-2016

معلومات المرضى النشرة: نشرة المعلومات, خصائص المنتج

Layout Management AM Seite 1 Bayer Schering Pharma

Mandant: 534 Stof f-Nr .: 64013113 PZ: 2613A-3 Code-Nr .: 20

Bezeichnung: Meliane 1x21, 3x21 Aufmachung: Israel BSP

Farben: Black

Version: 25.11.2008/01 Freigabe:

COMPOSITION:

Each tablet contains:

Gestodene 0.075 mg

Ethinylestradiol0.020 mg

Inactive ingredients:

Lactosemonohydrate,maizestarch,povidone25000,magnesiumstearate,sucrose,povidone

700000,polyethylene glycol 6000,calcium carbonate,talc,montanglycol wax(wax E).

Each tablet contains: 37.15 mg lactose monohydrate.

Each tablet contains: 19.66 mg sucrose.

THERAPEUTIC GROUP:Combined oral contraceptive pill(estrogen and progestogen).

THERAPEUTIC ACTIVITY:Oral contraception.

WHEN SHOULD THE PREPARATION NOT BE USED?

Do not use this medicine ifyou are pregnant or ifyou suspect you are pregnant.

Do not use this medicine ifyou are sensitive to any ofits ingredients.

Donotuseacombinedoralcontraceptivepill,suchas Meliane,inthefollowing

conditions:

Ifyouaresuffering,orhavesufferedinthepast,fromanillnessthataffectstheblood

circulation,especiallythromboticevents(thrombosis-theformationofabloodclot)that

mayoccurinthebloodvesselsofthelegs(deepveinthrombosis),inthelungs(pulmonary

embolism),intheheart(heartattack),inthebrain(cerebrovascularaccidentasaresultof

a blood clot or hemorrhage),or in other parts ofthe body.

Incases,pastorpresent,thatsignifyafirstsignofheartattack(e.g.anginapectorisor

chestpain)orofcerebrovascularaccident(e.g.transientischemicattackormildreversible

stroke).Ahistoryofmigraineaccompaniedbyvisiondisturbances,speechdisturbancesor

weakness/tinglingsensationinanypartofthebody,incasesofdiabeteswithvascular

damage,inpastorpresentcasesofpancreatitisaccompaniedbyhighbloodlipidlevels,in

casesofjaundiceoracuteliverdisease,pastorpresentcasesofhormonedependent

tumors(e.g.cancerofthebreastorofthereproductiveorgans),pastorpresentbenignor

malignantlivertumors,undiagnosedvaginalbleeding,sicklecellanemia,lipidmetabolism

disorders,historyofaggravatedotosclerosisduringpregnancy,itchingovertheentirebody,

jaundice during pregnancy.

Ifanyoftheabovecasesoccursforthefirsttimewhileusingthismedicine,discontinueuse

andconsultyourattendingdoctor.Inthemeantimeusenon-hormonalcontraceptive

measures.

Do not use the medicine without consulting a doctor before starting treatment:

Ifyou are breastfeeding.

Ifyousmoke,ifyouaresuffering,orhavesufferedinthepast,fromimpairedfunctionofthe

heart-abnormalvalveorarrhythmia,theliver(jaundice)orgallbladder,thekidney/urinary

tract,andalsoifyouaresufferingorhavesufferedfromoneofthefollowingailments:

hypertension,diabetes,overweight,varicoseveins,phlebitis,familyhistoryofthrombosis,

heartattackorcerebrovascularaccident,migraine,epilepsy,highlevelsofcholesterolor

triglyceridesintheblood(alsoifthereisafamilyhistory),familyhistoryofbreastcancer,

Crohn’sdisease,ulcerativecolitis,systemiclupuserythematosus,hemolyticuremicsyndrome,

conditionswhichoccurforthefirsttimeorworseninthecourseofpregnancyortaking

hormones,suchasporphyria,ahistoryofgestationalherpes,Sydenham’schorea(a

neurologicaldisease),chloasma(pigmentpatchesontheskin,especiallytheface),

depression,multiple sclerosis,or intolerance to contact lenses.

Ifanyoftheabovephenomenaoccursforthefirsttime,recursorworsenswhileusingthe

medicine,consult your doctor.

HOW WILL THE MEDICINE AFFECT YOUR DAILY LIFE?

Theriskofarterialthrombosisandseriouscardiovascularsideeffectsassociatedwithoral

contraceptivepillincreaseswithage.Thisriskincreasesinwomenwhoareheavysmokers,

especiallyiftheyareabove35yearsofage.Itisthereforerecommendednottosmokewhile

using the medicine.

WARNINGS:

Thismedicine,likeeveryoralcontraceptivepill,doesnotprotectyoufromcontractingAIDS

or any other sexually transmitted disease.

Beforestartingtreatment,youshouldundergoacompletegeneralandgynecological

examination and ascertain that you are not pregnant.

Aswithanylong-termuseofhormonalpreparations,ifyouareusingthismedicinefora

prolongedperiod,youshouldvisityourdoctorevery6monthsforaroutinegynecological

examination.Itisalsorecommendedthatyouhaveyourbloodpressuremonitoredevery6

months.

Familyhistoryshouldbeseriouslytakenintoconsideration.Bloodcoagulationdisorders

mustberuledoutifanymemberofthefamilyhassufferedathrombo-embolicdisease(for

instance,deepveinthrombosis,cerebrovascularaccident,myocardialinfarction)atayoung

age.

Venous thrombosis is rare.

Theriskofdevelopingvenousthrombosiswhiletakingoralcontraceptivepillisgreatest

Venousthrombosiscandevelopevenifyouarenottakinganoralcontraceptivepill;itcan

occurevenifyoubecomepregnant.Theriskofvenousthrombosisishigheramongusersof

the pill than among non-users,but it is not as great as the risk during pregnancy.

Rarely,bloodclotsmay forminthebloodvesselsoftheheart(causingheartattack),orofthe

brain(causingstroke).Intherarestcases,bloodclotsmayoccurintheliver,intestines,kidneys

or in the eyes.Sometimes thrombosis may cause functional impairments or even death.

Theriskofthrombosisincreasestemporarilyaftersurgeriesorduringperiodsofimmobilization.

Therefore,ifyouhavetoundergosurgeryorbehospitalized,informyourdoctoratleast4

weeksinadvancethatyouaretakingthepill.Ifyoudevelophighbloodpressurewhileusing

the medicine,you may have to stop using it.

Amongwomenwhousedoralcontraceptivepillafewmorecasesofbreastcancerwere

diagnosedthanamongwomenofthesameagewhodidnotusethepill.Thissmallincrease

inthenumberofbreastcancerdiagnosesgraduallydisappearsduringthe10yearsfollowing

discontinuation oftaking the pill.

Itisnotknownifthedifferenceiscausedasaresultofusingthepill.Itmaybethatthefact

thatthesewomenwereexaminedmorefrequentlyledtoearlierdiagnosisofthebreast

cancer.

Inrarecases,benigntumorsoftheliverwereobservedandinrarercases,malignanttumors

oftheliverwereobserved,thatledinisolatedcasestodangerousintra-abdominal

hemorrhage,followingtheuseoftheoralcontraceptivepill.Thus,youshouldnotifyyour

doctorofanyseverepainintheupperabdomenthatdoesnotdisappearspontaneouslyafter

a short time.

Themostimportantriskfactorforcervicalcancerisaprolongedviralinfectioncausedby

humanpapillomavirus.Severalstudieshaveshownthatprolongeduseofthepillmay

contributetoincreasingtherisk;however,controversystillexistsastowhetherthesefindings

mayalsoberelatedtootherfactors,suchascervicalexaminations,sexualhabitsofusers

and the use ofadditional contraceptive measures(barrier contraceptives).

Ifyouareabouttoundergolaboratorytestsyoumustnotifyyourdoctor,sincetheremaybe

changes in their results.

Ifyouaresensitivetoanytypeoffoodormedicine,informyourdoctorbeforecommencing

treatment with the medicine.

The medicine contains lactose monohydrate and sucrose.

DRUG INTERACTIONS:

Ifyouaretakingotherdrugsconcomitantlyorifyouhavejustfinishedtreatmentwithother

medicines,includingnon-prescriptionmedicinesandfoodsupplements,informtheattending

doctorinordertopreventhazardsorlackofefficacyarisingfromdruginteractions.Thisis

especiallyimportantformedicinesbelongingtothefollowinggroups:antiepileptics(e.g.:

phenytoin,barbiturates,primidone,carbamazepine,oxcarbazepine,topiramate,felbamate),

medicinesfortreatmentoftuberculosis(e.g.:rifampicin,rifabutin),antibioticsforthe

treatmentofinfectiousdiseases(e.g.:penicillin,tetracycline,griseofulvin-antifungal),

medicinesfortreatingAIDS-relatedinfections(suchasritonavir),theherbalpreparationSt.

John‘s wort( hypericum,for treatment ofdepressive moods).

Someofthesedrugsmayreducetheefficacyofthismedicineasacontraceptive.Therefore,

duringconcomitantuseitisrecommendedtouseanadditional,non-hormonal,contraceptive

method.

For further questions,consult your doctor.

SIDE EFFECTS:

Inadditiontothedesiredeffectofthemedicine,adversereactionsmayoccurduringthe

course oftreatment.

Commonsideeffects:nausea,abdominalpain,weightgain,headache,moodchanges/

depressive mood,breast pain or tenderness.

Uncommonsideeffects:vomiting,diarrhea,fluidretention,migraine,decreasedlibido,

enlargement ofthe breasts,rash,urticaria.

Raresideeffects:intolerancetocontactlenses,hypersensitivityreactions,weightloss,

increasedlibido,vaginaldischarge,dischargefromthebreasts,erythemanodosum,erythema

multiforme.

Thesesideeffectsusuallydisappearwithinashorttimefollowingtheperiodofadaptationto

the medicine.Ifthey persist or become bothersome,refer to your doctor.

Prolongeduseofthemedicinemaysometimescausebrownspotsontheskininsensitive

women.Prolongedexposuretosunlightmayaggravatethesespots.Therefore,womenwith

such a tendency must avoid prolonged exposure to sunlight or to ultra-violet radiation.

Effects that require special attention:

Stoptakingthemedicineimmediatelyandconsultyourdoctorinthefollowingcases,which

may be signs ofthrombosis,ofheart attack or ofcerebrovascular accident:

Unusualcough,sharpchestpainradiatingtotheleftarm,suddenshortnessofbreathor

difficultybreathing,migrainetypeheadacheoccurringforthefirsttime,anyheadachesthat

occurwithunusualfrequencyorunusualintensity,anyacutedisturbancesinvision,speech

disorders,sudden changes in hearing,or in the sense ofsmell or taste,dizzinessor fainting,a

feelingofweaknessortinglinginanypartofthebody,strongabdominalpains,unusualpain

or swelling ofthe legs.

Further reasons to rapidly consult the doctor are:

itchingalloverthebody,increasedfrequencyofepilepticseizures(involuntarymovements),

significantincreaseinbloodpressure,pregnancyorsuspicionofpregnancy,heavyand

unusualvaginalbleeding,severediarrhea,incaseyouforgottotakethetabletinthefirst

weekandhadsexualintercourseduringtheprecedingweek(duringthetablet-freeweek),

fourweeksbeforeplannedsurgeryorduringperiodsofimmobility,forexample:afteran

accident.

Intheeventthatyouexperiencesideeffectsnotmentionedinthisleaflet,orifthereisa

change in your general health,consult your doctor immediately.

DOSAGE AND INSTRUCTIONS FOR USE:

Apackageof Melianecontains21tablets.Thedayoftheweekandanarrowindicatingin

whichdirectiontoproceedaremarkedonthepackaboveeachtablet.Takethetabletwhole

withwaterasneeded,eachdayatthescheduledhour.Donotchewthetablet.Takethe

tablets according to the direction ofthe arrows until the package is finished.

After21daysoftakingthetablets,takea7dayintermission.Duringthese7intermission

daysmenstrualbleedingshouldoccur,usually2-3daysaftertakingthelasttablet.Start

takingthetabletsfromthenextpackageontheeighthday,evenifmenstrualbleeding

continues.

In this way you will start a new package each month on the same day ofthe week.

TakingMelianefor the first time:

Takethefirsttabletonthefirstdayofmenstrualbleeding.Takethetabletmarkedwiththe

appropriate day ofthe week.

Continuetakingthetabletsaccordingtothedirectionofthearrowsuntilthepackisfinished.

Youareprotectedfrompregnancyimmediately.Youcanevenbegintakingthetabletsbetween

thesecondtofifthdayofmenstrualbleeding,butinthiscaseyoumustuseanadditional

method ofcontraception during the first 7 days ofthe first month oftaking the pill.

Changing from another combined pill toMeliane:

Starttaking Melianethefirstdayafteryoufinishtakingtheotheroralcontraceptivepill(i.e.

thereisnointermissionbetweentakingthepills).Ifyourpresentpackagecontainsinactive

tablets,starttaking Melianethedayaftertakingthelastactivetablet(ifyouarenotsure

what an active tablet is,consult your doctor or pharmacist).

Changing from a progestogen only pill to Meliane:

Start on the first day ofmenstrual bleeding.

Afterdelivery:Thedoctorwillgenerallyadviseyoutowaituntilafterthefirstperiodbefore

starting to use Meliane.

After abortion/curettage:Consult your doctor.

HOW CAN YOU CONTRIBUTE TO THE SUCCESS OF THE TREATMENT?

Ifyou forgot to take one or more Meliane tablets:

A less than 12-hour delay in taking one tablet:

Ifyouforgottotake Meliane,takethetabletasquicklyaspossibleandcontinuetakingthe

restofthetabletsasusualinthedirectionofthearrow.Yourprotectionfrompregnancyhas

not been impaired.

A delay ofmore than 12 hours in taking one tablet:

Ifmorethan12hourshaveelapsedtakethemissedtabletassoonasyouremember,then

continuetakingtherestofthetabletsasusual,evenifthismeanstaking2tabletsonthe

sameday.Concurrently,youshoulduseanadditionalcontraceptivemethod(forinstance,a

condom,spermicide,etc.)for the next 7 days.

Additionally,ifyouforgottotakethetabletduringthelast7days,finishthepackand

continuewiththenextpackwithoutanybreak.Ifnobleedingoccursafterfinishingthe

second pack,consult your doctor before you resume taking the tablets.

Ifyou forgot to take more than one Melianetablet,consult your doctor.

Efficacy in cases ofvomiting or diarrhea:

Mildlaxativesdonotreducethereliabilityofthepill.However,ifyousufferfromastomach

upsetleadingtoseverevomitingordiarrhea,thereisnoabsoluteguaranteethatthedaily

tabletwillbetotallyabsorbedfromthegastrointestinaltract.Ifvomitingoccurswithin3-4

hoursaftertakingthetablet,thesituationissimilartohavingforgottentotakethetablet;

therefore,follow the directions given for such a situation.

Ifyou have severe diarrhea,consult your doctor.

Ifbleeding occurs in between cycles:

Duringthefirstmonthsbreakthroughbleeding(spottingorlightbleeding)mayoccur.This

breakthroughbleedingwillgenerallystoponceyourbodyadaptstotheuseofthepill

(usuallyafterthreecyclesoftakingthepill).Therefore,continuetakingthetablets.If

bleedingisheavy,persistentorrecursrefertoyourdoctor.Ifmenstrualbleedingdoesnot

occurrefertoyourdoctorimmediatelyinordertoruleoutthepossibilityofpregnancy.Inany

case,do not start a new series oftablets without consulting the doctor.

AVOID POISONING!

Thismedicineandallothermedicines,mustbestoredinasafeplaceoutofthereachof

childrenand/orinfants,toavoidpoisoning.Ifyouhavetakenanoverdose,orifachildhas

accidentallyswallowedthepreparation,proceedimmediatelytoahospitalemergencyroom

and bring the package ofthe medicine with you.

Do not induce vomitingunless explicitly instructed to do so by a doctor!

Thismedicinehasbeenpersonallyprescribedforyouasanoralcontraceptive,inanother

womenitmaycauseharm. Donotgivethismedicinetoyourrelatives,neighboursor

acquaintances. Donottakemedicinesinthedark!Checkthelabelandthedoseeachtime

you take this medicine.Wear glasses ifyou need them.

STORAGE:

Do not store at a temperature above25°C.Protect from light.

Evenifkeptintheiroriginalcontainerandstoredasrecommended,medicinesmaybekeptfor

alimitedperiodonly.Pleasenotetheexpirydateofthemedicine!Incaseofdoubt,consultthe

pharmacist who dispensed the preparation to you.

Do not store different medications in the same package.

LICENSE NUMBER:109 12 29094 00

MANUFACTURER:Delpharm Lille S.A.S.,Lys Lez Lannoy,France.

REGISTRATION HOLDER:Bayer Israel Ltd.,

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS(PREPARATIONS)- 1986

The dispensing ofthis medicine requires a doctor‘s prescription

Read this package insert carefully in its entirety before using this medicine

The format ofthis leaflet was determined by the Ministry ofHealth and its content was checked and approved by it in August 2010

Meliane®

Coated Tablets

Layout Management AM Seite 2 Bayer Schering Pharma

Mandant: 534 Stof f-Nr .: 64013113 PZ: 2613A-3 Code-Nr .: 20

Bezeichnung: Meliane 1x21, 3x21 Aufmachung: Israel BSP

Farben: Black

Version: 25.11.2008/01 Freigabe:

1986- ו"משתה )םירישכת( םיחקורה תונקת יפל תינכרצל ןולע

אפור םשרמב תבייח וז הפורת

הפורתב ישמתשת םרטב ופוס דע ןולעה תא ןויעב יארק

2010טסוגואב ודי-לע רשואו קדבנ ונכותו תואירבה דרשמ ידי-לע עבקנ הז ןולע טמרופ

:בכרה

:הליכמ הילבט לכ

Gestodene 0.075 mg

Ethinylestradiol 0.020 mg

:םיליעפ יתלב םירמוח

Lactosemonohydrate,maizestarch,povidone25000,magnesiumstearate,sucrose,

povidone700000,polyethyleneglycol6000,calciumcarbonate,talc,montanglycolwax

(wax E).

.טארדיהונומ זוטקל ג"מ37.15:הליכמ הילבט לכ

.זורכוס ג"מ19.66:הליכמ הילבט לכ

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.ןוירה תעינמל הלולג:תיאופר תוליעפ

?רישכתב שמתשהל ןיא יתמ

.ןוירהל ששח םייק םא וא ןוירהב ךניה רשאכ הפורתב ישמתשת לא

.הפורתה יביכרממ דחאל תושיגר ךל העודי םא שמתשהל ןיא

:םיאבה םיבצמב ,ןאילמןוגכ ,ןוירה תעינמל תבלושמ הלולג לוטיל ןיא

םיכילהתבדחוימב,םדהרוזחמלעהעיפשמההלחממרבעבתלבסואתלבוסךניהםא

תקקפ(םיילגרהלשםדהילכברצוויהלםילולעש)םדשירקתורצוויה-תקקפ(םייטובמורת

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.ףוגה לש םירחא םיקלחב וא )םומיד וא םד שירקמ

ואסירוטקפהניגנאןוגכ(בלףקתהלןושארןמיסםיווהמה,הווהבוארבעב,םירקמב

לשהירוטסיה.)ךיפהלקץבשואףלוחימכסיאףקתהןוגכ(יחומעוריאלוא)הזחבםיבאכ

יקלחמדחאבלומינתשוחת/השלוחוארובידבתוערפה,הייארבתוערפהבהוולמההנרגימ

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.םיילנומרוה אל העינמ יעצמאב שמתשהל שי םייתניב .לפטמה אפורה םע ץעייתהלו

:לופיטה תלחתה ינפל אפורב ץעוויהל ילבמ הפורתב שמתשהל ןיא

.הקינמ ךניה םא

ןיקתאלםתסמ-בלהדוקפתביוקילמרבעבתלבסואתלבוסךניהםא,תנשעמךניהםא

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,םיילגרבתוילד,רתילקשמ,תרכוס,םדץחלרתי:תואבהתולחמהתחאמתלבסואתלבוס

ןויפכ,הנרגימ,יחומעוריאואבלףקתה,הזובמורתלשתיתחפשמהירוטסיה,םידירותקלד

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,ןוירהבספרהלשהירוטסיה,היריפרופןוגכםינומרוהתליטנואןוירהךלהמבורימחהוא

,)םינפבדחוימב,רועהלעהיצטנמגיפימתכ(המזאולכ,)תיבצעהלחמ( Sydenham’schorea

.עגמ תושדעל תוליבס יא וא ,הצופנ תשרט ,ןואכיד

שומישהתעבהרימחהואבושהעיפוה,הנושארלהעיפוהתורכזנהתועפותהמתחאםא

.אפורב ץעוויהל ךיילע ,הפורתב

?ךלש םוי םויה ייח לע הפורתה עיפשת ךיא

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.הפורתב שומישה ןמזב ןשעל אל ץלמומ ,ךכל יא .35ליג לעמ ןה םא דחוימב ,תוירגיס

:תורהזא

לכואסדייאהתלחמבתוקבדיהינפמהנגמהניא,ןוירהתעינמלהלולגלכומכ,וזהפורת

.ינימ עגמב תרבעומה תרחא הלחמ

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םינמיסתויהלםילוכיש,םיאבהםירקמבאפורבץעוויהלודימהפורתהתליטנתאקיספהלשי

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םילוח-תיבלשןוימרדחלדימינפ,הפורתהןמדליעלבתועטבםאוארתיתנמתלטנםא

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ינתיתלא.קיזהלהלולעאיהתרחאהשיאל,ןוירהתעינמלךרובעתישיאהמשרנוזהפורת

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ןאילמ

תופוצמ תוילבט

24-11-2018

Blokhuis: 1,25 miljoen euro voor educatie Tweede Wereldoorlog

Blokhuis: 1,25 miljoen euro voor educatie Tweede Wereldoorlog

Staatssecretaris Paul Blokhuis van Volksgezondheid, Welzijn en Sport heeft 1,25 miljoen euro beschikbaar gesteld voor educatieprojecten over de Tweede Wereldoorlog. In 2019 en 2020 vieren we dat Nederland 75 jaar is bevrijd, eerst het zuidelijke deel in 1944 en daarna de rest van Nederland en Nederlands-Indië in 1945. Dit lustrumjaar wordt de bevrijding nog groter gevierd dan anders en wordt er extra nadruk gelegd op het herinneren van de oorlog. De 1,25 miljoen euro komt boven op de 3,5 miljoen voor ond...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

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

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

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

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

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

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

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

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Nederland organiseert volgende wereldwijde WHO conferentie tegen tabak

Nederland organiseert volgende wereldwijde WHO conferentie tegen tabak

In 2020 organiseert Nederland de volgende wereldwijde conferentie van de Wereldgezondheidsorganisatie tegen tabak. Het gaat om de negende editie van de zogenaamde Conference of the Parties (COP) van het WHO FCTC verdrag. Dat is vandaag bekendgemaakt in Genève tijdens de sluitingsceremonie van de achtste COP. Staatssecretaris Paul Blokhuis (VWS) heeft het initiatief genomen om de conferentie naar Nederland te halen en was op 1 oktober in Genève om de Nederlandse kandidatuur kracht bij te zetten.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

4-10-2018

Peer review of the pesticide risk assessment of the active substance ethoprophos

Peer review of the pesticide risk assessment of the active substance ethoprophos

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

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

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

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

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch, because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

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

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

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

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

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

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 authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

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

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

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

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

22-10-2018

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Eisai GmbH)

EU/3/01/075 (Active substance: Denileukin diftitox) - Transfer of orphan designation - Commission Decision (2018)6991 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/038/01/T/02

Europe -DG Health and Food Safety