Capecitabine Accord

Glavna informacija

  • Trgovački naziv:
  • Capecitabine Accord
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Capecitabine Accord
    Europska Unija
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Terapijska grupa:
  • Antineoplastična sredstva
  • Područje terapije:
  • Kolorektalne neoplazme
  • Terapijske indikacije:
  • Kapecitabinski sporazum je indiciran za adjuvantno liječenje pacijenata nakon operacije stadija III (Dukes stage-C) raka debelog crijeva.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/002386
  • Datum autorizacije:
  • 20-04-2012
  • EMEA koda:
  • EMEA/H/C/002386
  • Zadnje ažuriranje:
  • 26-02-2018

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacija za korisnika

Kapecitabin Accord 150 mg filmom obložene tablete

Kapecitabin Accord 300 mg filmom obložene tablete

Kapecitabin Accord 500 mg filmom obložene tablete

kapecitabin

Pažljivo pročitajte cijelu uputu prije nego počnete uzimati ovaj lijek jer sadrži Vama važne

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se svom liječniku ili ljekarniku.

Ovaj je lijek propisan samo Vama. Nemojte ga davati drugima. Može im naškoditi, čak i ako su

njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika. To uključuje

i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Pogledajte dio 4.

Što se nalazi u ovoj uputi:

Što je Kapecitabin Accord i za što se koristi

Što morate znati prije nego počnete uzimati Kapecitabin Accord

Kako uzimati Kapecitabin Accord

Moguće nuspojave

Kako čuvati Kapecitabin Accord

Sadržaj pakiranja i dodatne informacije

1.

Što je Kapecitabin Accord i za što se koristi

Kapecitabin Accord pripada skupini lijekova pod nazivom "citostatici", koji zaustavljaju rast stanica

raka. Kapecitabin Accord sadrži kapecitabin, koji sam po sebi nije citostatik. Tek nakon što se

apsorbira u organizmu, mijenja se u djelatnu antikarcinogenu tvar (više u tumorskom tkivu nego u

zdravom tkivu).

Kapecitabin Accord se koristi za liječenje karcinoma debelog crijeva, rektuma, želuca ili dojke.

Nadalje, Kapecitabin Accord se koristi kako bi se spriječila pojava novog karcinoma debelog crijeva

nakon što je tumor u potpunosti kirurški uklonjen.

Kapecitabin Accord se može primijeniti samostalno ili u kombinaciji s drugim lijekovima.

2.

Što morate znati prije nego počnete

uzimati Kapecitabin Accord

Nemojte uzimati Kapecitabin Accord

ako ste alergični (preosjetljivi) na kapecitabin ili bilo koji drugi sastojak ovog lijeka (navedeni u

dijelu 6). Morate obavijestiti svog liječnika ako znate da ste alergični ili preosjetljivi na ovaj

lijek,

ako ste ranije imali teške reakcije na terapiju fluoropirimidinima (skupinu antikancerogenih

lijekova kao što je fluorouracil)

ako ste trudni ili ako dojite,

ako imate izrazito nisku razinu bijelih krvnih stanica ili trombocita u krvi (leukopenija,

neutropenija ili trombocitopenija)

ako imate teške tegobe jetre ili bubrega,

ako znate da nemate nikakvu aktivnost enzima dihidropirimidin dehidrogenaze (DPD)

ako primate terapiju ili ste primali terapiju brivudinom, sorivudinom ili sličnim tvarima kao dio

liječenja herpes zostera (vodene kozice ili herpes zoster) unutar zadnja 4 tjedna.

Upozorenja i mjere opreza

Prije početka liječenja Kapecitabinom Accord, porazgovarajte s liječnikom ako

znate da imate djelomičan nedostatak aktivnosti enzima dihidropirimidin dehidrogenaze (DPD)

imate bolest jetre ili bubrega

imate ili ste imali srčane probleme (na primjer nepravilan rad srca) ili bolove u prsima, čeljusti i

leđima, koji se javljaju uslijed fizičkog napora, a zbog problema s protokom krvi do srca

imate bolest mozga (na primjer rak koji se proširio na mozak) ili oštećenja živaca (neuropatija)

imate poremećaj razine kalcija (vidljivo u nalazima krvi)

imate šećernu bolest

možete zadržati hranu ili vodu u vašem tijelu usljed jake mučnine ili povraćanja

imate proljev

ste ili postajete dehidrirani

imate neravnotežu iona u krvi (neravnoteža elektrolita vidljiva u nalazima)

ste ranije imali očnih tegoba jer će vam možda biti potrebna dodatna kontrola očiju

imate tešku kožnu reakciju.

Pomanjkanje DPD:

Pomanjkanje DPD je rijetko stanje prisutno kod rođenja koje inače nije povezano

sa zdravstvenim problemima osim u slučaju uzimanja nekih lijekova. Ako imate neprepoznatu DPD

deficijenciju i uzimate Kapecitabin Accord, imate povećan rizik od akutnog ranog nastupa teških

oblika nuspojava navedenih u dijelu 4 Moguće nusppojave. Odmah se javite svim liječniku ako ste

zabrinuti zbog neke od nuspojava ili ako primijetite dodatne nuspojave koje nisu navedene u ovoj

uputi o lijeku (pogledajte dio 4 Moguće nuspojave).

Djeca i adolescenti

Kapecitabin Accord nije indiciran u djece i adolescenata. Kapecitabin Accord nemojte davati djeci i

adolescentima.

Drugi lijekovi i Kapecitabin Accord

Prije početka liječenja obavijestite svog liječnika ili ljekarnika ukoliko uzimate ili ste nedavno uzimali

ili biste mogli uzeti bilo koje druge lijekove. To je vrlo važno jer istovremeno uzimanje više lijekova

može pojačati ili oslabiti učinak lijeka. Osobito budite oprezni ako uzimate neki od ovih lijekova:

lijekove za giht (alopurinol),

lijekove protiv zgrušavanja krvi (kumarin, varfarin),

određene antivirusne lijekove (sorivudin i brivudin),

lijekove protiv napadaja ili nevoljnog drhtanja (fenitoin),

lijek za liječenje raka (interferon alfa)

radioterapiju i određene lijekove za liječenje karcinoma (folinatna kiselina, oksapilatin,

bevacizumab, cisplatin, irinotekan).

lijekove za liječenje nedostatka folne kiseline.

Kapecitabin Accord s hranom i pićem

Kapecitabin Accord uzmite najkasnije 30 minuta nakon jela.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da bi mogli biti trudni ili planirate imati dijete, obratite se svom

liječniku ili ljekarniku za savjet prije mego uzmete ovaj lijek.Kapecitabin Accord ne smijete uzimati

ako ste trudni ili mislite da ste trudni.

Ako uzimate Kapecitabin Accord ne smijete dojiti.

Obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Upravljanje vozilima i strojevima

Dok uzimate Kapecitabin Accord možete osjećati omaglicu, mučninu ili umor. Stoga postoji

mogućnost utjecaja Kapecitabina Accord na sposobnost upravljanja vozilima i strojevima. Nemojte

voziti ako osjećate omaglicu, mučninu ili umor nakon uzimanja ovog lijeka.

Kapecitabin Accord sadrži laktozu

Ovaj lijek sadrži laktozu. Ako vam je liječnik rekao da ne podnosite neke vrste šećera, obratite mu se

prije uzimanja ovog lijeka.

3.

Kako uzimati Kapecitabin Accord

Ovaj lijek uvijek uzimajte točno onako kako vam je rekao vaš liječnik ili ljekarnik. Posavjetujte se s

vašim liječnikom ili ljekarnikom ako niste sigurni.

Kapecitabin Accord treba propisati samo liječnik s iskustvom u primjeni lijekova protiv karcinoma.

Liječnik će Vam propisati dozu i način primjene koji je najučinkovitiji za Vas. Doza Kapecitabina

Accord ovisi o Vašoj tjelesnoj površini, a izračunava se na temelju Vaše visine i težine. Uobičajena

doza za odrasle iznosi 1250 mg/m

tjelesne površine koja se uzima dvaput dnevno (ujutro i navečer).

Ovdje su navedena dva primjera: osoba čija tjelesna težina iznosi 64 kg, a visina 1,64 m ima tjelesnu

površinu od 1,7 m

te mora uzimati 4 tablete od 500 mg i 1 tabletu od 150 mg dvaput dnevno. Osoba

čija tjelesna težina iznosi 80 kg, a visina 1,80 m ima tjelesnu površinu od 2,00 m

mora uzimati 5

tableta od 500 mg dvaput dnevno.

Liječnik će Vam reći koja doza Vam je potrebna, kada je uzeti i koliko dugo je morate uzimati.

Liječnik će možda zahtijevati da za svaku dozu uzimate kombinaciju tableta od

150 mg

500 mg

Tablete uzimajte

ujutro i navečer

, kako Vam je propisao liječnik.

Tablete uzimajte najkasnije

30 minuta nakon što završite s jelom

(doručkom i večerom)

i

progutajte ih cijele, s vodom

Važno je da lijek uzimate na način koji Vam je propisao liječnik.

Kapecitabin Accord

se preporučuje uzimati 14 dana, nakon čega slijedi 7 dana pauze (bez uzimanja

tableta). To razdoblje od 21 dan smatra se jednim ciklusom liječenja.

U kombinaciji s drugim lijekovima uobičajena doza za odrasle može biti manje od 1250 mg/m

tjelesne površine, i moguće je da ćete uzimati tablete u drugo vrijeme (npr. svaki dan, bez prekida).

Ako uzmete više Kapecitabina Accord nego što ste trebali

Ako uzmete više Kapecitabina Accord nego što ste trebali obratite se svom liječniku čim prije, prije

uzimanja sljedeće doze.

Možda ćete imati sljedeće nuspojave ako uzmete puno više kapecitabina nego što ste trebali, mučninu

i povraćanje, proljev, upalu ili ulceraciju u probavnom sustavu ili ustima, bol ili krvarenje iz crijeva ili

želuca, ili smanjenje koštane srži (smanjenje određene vrste krvnih stanica). Odmah obavijestite svog

liječnika ako imate bilo koji od ovih simptoma.

Ako ste zaboravili uzeti Kapecitabin Accord

Nemojte uzeti propuštenu dozu. Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu

dozu. Umjesto toga nastavite uzimati lijek prema propisanom rasporedu i posavjetujte se sa svojim

liječnikom.

Ako prestanete uzimati Kapecitabin Accord

Nema nuspojava uzrokovanih prestankom liječenja kapecitabinom. Ako slučajno uzimate

antikoagulanse kumarinskog tipa (koji sadrže npr. fenoprokumon), nakon prestanaka uzimanja

kapecitabina možda će vam liječnik morati prilagoditi dozu antikoagulansa.

Ako imate dodatnih pitanja kako uzimati ovaj lijek, obratite se svom liječniku ili ljekarniku.

4.

Moguće nuspojave

Kao i svi drugi lijekovi, i ovaj lijek

može izazvati nuspojave, iako se one ne javljaju kod svih osoba.

Odmah

PRESTANITE

uzimati Kapecitabin Accord i obratite se liječniku ako se pojave neki od ovih

simptoma:

proljev:

ako se pražnjenje crijeva poveća za 4 ili više pražnjenja u usporedbi s normalnim

svakodnevnim pražnjenjem crijeva ili ako imate proljev noću.

povraćanje:

ako povratite više od jednom u 24 sata.

mučnina:

ako izgubite apetit, a količina hrane koju svakodnevno konzumirate znatno je manja

nego inače.

stomatitis:

osjećate li bol, crvenilo, oteklinu ili imate rane u ustima.

kožna reakcija na rukama i stopalima:

ako osjećate bol, imate otečene, crvene ruke i/ili stopala

ili trnci u rukama i/ili stopalima.

vrućica:

ako imate temperaturu od 38°C ili višu.

upala:

ako primijetite znakove upale uzrokovane bakterijom ili virusom, ili drugim

organizmima.

bol u prsima:

ako osjetite bol u sredini prsnog koša, osobito ako se pojavi tijekom vježbanja.

Stevens-Johnsonov sindrom:

ako dobijete bolan crveni ili ljubičasto-crveni osip koji se širi i

počnu se javljati mjehurići i/ili druga oštećenja na sluznici (npr. u ustima i na usnicama),

osobito ako ste ranije bili osjetljivi na svjetlost ili imali infekcije dišnog sustava (npr. bronhitis)

i/ili vrućicu.

Nedostatak DPD-a:

Ako imate nedostatak DPD-a, imate povećan rizik od akutnog ranog

nastupa toksičnosti i teških, po život opasnih ili smrtonosnih nuspojava koje uzrokuje

Kapecitabin Accord (npr. stomatitis, upala sluznica, proljev, neutropenija i neurotoksičnost).

Ako se zamijete u ranoj fazi, te se nuspojave povlače unutar 2 do 3 dana nakon prestanka liječenja.

Ako se nuspojave ne povuku, odmah se obratite svom liječniku. Liječnik će vam možda savjetovati da

ponovno počnete liječenje manjom dozom.

Kožna reakcija na šakama i stopalima može dovesti do gubitka otisaka prstiju, što može utjecati na

Vašu identifikaciju skeniranjem otisaka prstiju.

Dodatno na gore navedeno, kada se kapecitabin koristi sam,

vrlo česte

nuspojave koje se mogu javiti u

više od 1 na 10 osoba su:

Bol u trbuhu

Osip, suha koža ili svrbež

Umor

Gubitak apetita (anoreksija)

Ove nuspojave mogu postati teške, stoga je važno da se

uvijek obratite svom liječniku odmah

čim

uočite nuspojave. Liječnik vam može savjetovati da smanjite dozu i/ili privremeno prestanete uzimati

Kapecitabin Accord. Time će se smanjiti vjerojatnost da se nuspojave produlje i razviju u težem

obliku.

Ostale nuspojave su:

Česte

nuspojave (mogu se javiti u do 1 na 10 osoba) su:

smanjenje broja bijelih krvnih stanica ili crvenih krvnih stanica (uočeno u nalazima)

dehidracija, gubitak tjelesne težine

nesanica (insomnija), depresij

glavobolja, pospanost, omaglica, abnormalna osjetljivost kože (obamrlost ili trnci), promjene

okusa

nadražaj očiju, pojačano suzenje očiju, crvenilo očiju (konjunktivitis)

upala vena (tromboflebitis)

nedostatak zraka, krvarenje iz nosa, kašalj, curenje iz nosa

herpes na usnici ili druge infekcije herpesom

infekcije pluća ili dišnih puteva (npr. upala pluća ili bronhitis)

krvarenje iz crijeva, zatvor, bolovi u gornjem dijelu trbuha, probavne tegobe, prekomjerni

vjetrovi, suhoća usta

osip na koži, gubitak kose (alopecija), crvenilo kože, suhoća kože, svrbež (pruritus), promjena

boje kože, gubitak kože, upala kože, poremećaj noktiju

bolovi u zglobovima ili udovima (ekstremitetima), bolovi u prsima ili leđima

vrućica, oticanje udova, osjećaj da ste bolesni

problemi s funkcijom jetre (na rezultatima nalaza krvi) i povišen bilirubin u krvi (koji se

izlučuje iz jetre)

Manje česte

nuspojave (mogu se javiti u do 1 na 100 osoba) su:

infekcije krvi, infekcije mokraćnog sustava, infekcija kože, infekcije u nosu i grlu, gljivične

infekcije (uključujući i u ustima), gripa, gastroenteritis, apsces zuba

kvržice ispod kože (lipom)

smanjenje broja krvnih stanica, uključujući trombocite, razrjeđivanje krvi (vidjlivo u nalazima)

alergija

dijabetes, smanjenje kalija u krvi, pothranjenost, povišenje triglicerida u krvi

osjećaj zbunjenosti, napadi panike, depresivno raspoloženje, smanjen libido

poteškoće pri govoru, slabljenje pamćenja, gubitak koordinacije pokreta, poremećaji ravnoteže,

nesvjestica, oštećenja živaca (neuropatija) i problemi s osjetilima

zamagljenje vida i dvoslike

vrtoglavica, bolovi u uhu.

nepravilan rad srca i lupanje srca (aritmija), bolovi u prsnom košu i srčani udar (infarkt)

krvni ugrušci u dubinskim venama, visoki ili niski krvni tlak, navale vrućine, hladni udovi

(ekstremiteti), ljubičaste mrlje na koži

krvni ugrušci u venama u plućima (plućna embolija), kolaps pluća, iskašljavanje krvi, astma,

nedostatak zraka pri naporu

opstrukcija crijeva, skupljanje tekućine u trbuhu, upala tankog ili debelog crijeva, želuca ili

jednjaka, bol u donjem dijelu trbuha, nelagoda u trbuhu, žgaravica (refluks hrane iz želuca), krv

u stolici

žutica (žutilo kože i očiju)

čirevi i mjehurići na koži, reakcije kože na sunce, crvenilo dlanova, oteklina ili bol lica

oticanje zglobova ili ukočenost zglobova, bol u kostima, slabost mišića ili ukočenost

skupljanje tekućine u bubrezima, učestalo mokrenje tijekom noći, inkontinencija, krv u mokraći,

povišeni kreatinin u krvi (znak disfunkcije bubrega)

neuobičajeno krvarenje iz vagine

oticanje (edemi), zimica i tresavica

Neke od ovih nuspojava javljaju se češće kad se kapecitabin primjenjuje zajedno s drugim lijekovima

za liječenje raka. Ostale nuspojave primijećene u takvim okolnostima su:

Česte nuspojave

(mogu se javiti u do 1 na 10 osoba) uključuju:

smanjenje natrija, magnezija ili kalcija u krvi, povišenje šećera u krvi

bol u živcima

zvonjava ili zujanje u ušima (tinitus), gubitak sluha

upale vena

štucanje, promjene glasa

bol ili izmijenjen/abnormalan osjećaj u ustima, bol u čeljusti

znojenje, noćno znojenje

grčenje mišića

poteškoće pri mokrenju, krv ili proteini u mokraći

modrice ili reakcija na mjestu injekcije (uzrokovana lijekovima koje se daju putem injekcija u

isto vrijeme)

Rijetke

nuspojave (mogu se javiti u do 1 na 1 000 osoba) uključuju:

suženje ili začepljenje suznog kanala (stenoza suznog kanala)

zatajenje jetre

upale koje dovode do disfunkcije ili zapreke u izlučivanju žuči (kolestatski hepatitis)

specifične promjene u elektrokardiogramu (produljenje QT intervala)

određene vrste aritmija (uključujući ventrikularnu fibrilaciju,

torsade de pointes

i bradikardiju)

upala oka koja uzrokuje bol u očima i moguće tegobe s vidom

upala kože koja uzrokuje crvene ljuskave mrlje, a posljedica je bolesti imunološkog sustava

Vrlo rijetke

nuspojave (mogu se javiti u do 1 na 10 000 osoba):

teške kožne reakcije poput osipa kože, vrijedova i mjehurića koji mogu obuhvaćati vrijedove u

ustima, nosu, spolnim organima, šakama, stopalima i očima (crvene i otečene oči).

Prijavljivanje nuspojava

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika ili medicinsku

sestru. Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete

prijaviti izravno putem nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V.

Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Kapecitabin Accord

Ovaj lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza „Rok

valjanosti“.

Za aluminij-aluminijske blistere

Lijek ne zahtijeva posebne uvjete čuvanja.

Za PVC/PVdC-aluminijske blistere (perforirane djeljive na jedinične doze)

Nečuvati na temperaturi iznad 30°C.

Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad. Pitajte svog ljekarnika kako

baciti lijekove koje više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i dodatne informacije

Što Kapecitabin Accord sadrži

Djelatna tvar je kapecitabin.

Jedna filmom obložena tableta sadrži 150 mg kapecitabina.

Jedna filmom obložena tableta sadrži 300 mg kapecitabina.

Jedna filmom obložena tableta sadrži 500 mg kapecitabina.

Pomoćne tvari su:

Jezgra tablete: bezvodna laktoza, umrežena karmelozanatrij, hipromeloza,

mikrokristalična celuloza, magnezijev stearat

Ovojnica tablete (za 150 mg): hipromeloza, titanijev dioksid (E171), žuti željezov oksid,

crveni željezov oksid (E172), talk

Ovojnica tablete (za 300 mg): hipromeloza, titanijev dioksid (E171), talk

Ovojnica tablete (za 500 mg): hipromeloza, titanijev dioksid (E171), žuti željezov oksid,

crveni željezov oksid (E172), talk

Kako Kapecitabin Accord izgleda i sadržaj pakiranja

Kapecitabin Accord 150 mg filmom obložene tablete su svijetle boje breskve, duguljaste, bikonveksne

filmom obložene tablete, duljine 11,4 mm i širine 5,3 mm s utisnutom oznakom „150“ na jednoj i bez

oznake na drugoj strani.

Kapecitabin Accord 300 mg filmom obložene tablete su bijele do gotovo bijele boje, duguljaste,

bikonveksne filmom obložene tablete, duljine 14,6 mm i širine 6,7 mm s utisnutom oznakom „300“ na

jednoj i bez oznake na drugoj strani.

Kapecitabin Accord 500 mg filmom obložene tablete su boje breskve, duguljaste, bikonveksne filmom

obložene tablete, duljine 15,9 mm i širine 8.4 mm s utisnutom oznakom „500“ na jednoj i bez oznake

na drugoj strani.

Kapecitabin Accord je dostupan u blister pakiranjima koja sadrže 30, 60 ili 120 filmom obloženih

tableta ili perforiranim blisterima djeljivim na jedinične doze koji sadrže 30 x 1, 60 x 1 ili 120 x 1

filmom obloženih tableta.

Na tržištu se ne moraju nalaziti sve veličine pakiranja.

Nositelj odobrenja za stavljanje gotovog lijeka u promet

Accord Healthcare Limited,

Sage house, 319 Pinner Road,

North Harrow,

Middlesex HA1 4HF,

Ujedinjeno Kraljevstvo

Proizvođač

Accord Healthcare Limited,

Sage house, 319 Pinner Road,

North Harrow,

Middlesex HA1 4HF,

Ujedinjeno Kraljevstvo

Pharmacare Premium Limited,

HHF 003, Hal Far Industrial Estate Birzebbugia, BBG 3000, Malta

Ova uputa je zadnji puta revidirana u

Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove:

http://www.ema.europa.eu

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

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

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

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

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

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

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

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

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

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

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

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

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

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 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

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

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

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

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

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

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

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

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

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

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

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

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

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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 fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Tue, 28 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 sintofen. To assess the occurrence of sintofen 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 ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 27 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 prochloraz. To assess the occurrence of prochloraz residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as th...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Fri, 24 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

29-8-2018

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Explanatory note on the determination of newly expressed protein levels in the context of genetically modified plant applications for EU market authorisation

Published on: Mon, 20 Aug 2018 00:00:00 +0200 Genetically modified organisms are subject to a risk assessment and regulatory approval before entering the European market. According to legislation (Directive 2001/18/EC, Regulation (EC) No 1829/2003 and Regulation (EU) No 503/2013) and the EFSA guidance documents on the risk assessment of food and feed from genetically modified (GM) plants and on the environmental risk assessment of GM plants, applicants need to perform a molecular characterisation of any...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

Published on: Mon, 13 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 myclobutanil. To assess the occurrence of myclobutanil residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, the MRLs established by the Codex Alimentarius Com...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

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

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

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

FDA - U.S. Food and Drug Administration

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety

7-8-2018

Accofil (Accord Healthcare Limited)

Accofil (Accord Healthcare Limited)

Accofil (Active substance: Filgrastim) - Centralised - Yearly update - Commission Decision (2018)5428 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Accord Healthcare Limited)

Memantine Accord (Active substance: memantine) - Centralised - Renewal - Commission Decision (2018)5421 of Tue, 07 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2766/R/10

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

18-7-2018

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011.  Read more about preventing surgical fires here:  https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

#ICYMI - According to @PAPATIENTSAFETY June 2018 report, the number of reported surgical fires has decreased since 2011. Read more about preventing surgical fires here: https://go.usa.gov/xU5zs  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

4-7-2018

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Accord Healthcare Limited)

Docetaxel Accord (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)4341 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

3-7-2018

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Accord Healthcare Limited)

Temozolomide Accord (Active substance: temozolomide) - Centralised - Yearly update - Commission Decision (2018) 4240 of Tue, 03 Jul 2018

Europe -DG Health and Food Safety

11-6-2018

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Accord Healthcare Limited)

Pemetrexed Accord (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3761 of Mon, 11 Jun 2018

Europe -DG Health and Food Safety