Docetaxel Accord

Glavna informacija

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

Dokument

Lokalizacija

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

Terapeutski informacija

  • Terapijska grupa:
  • Antineoplastična sredstva
  • Područje terapije:
  • Karcinom, ne-malih stanica pluća
  • Terapijske indikacije:
  • Rak dojke.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/002539
  • Datum autorizacije:
  • 22-05-2012
  • EMEA koda:
  • EMEA/H/C/002539
  • Zadnje ažuriranje:
  • 27-02-2018

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za bolesnika

Docetaxel Accord 20 mg/1ml koncentrat za otopinu za infuziju

Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju

Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju

docetaksel

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

važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se liječniku, bolničkom ljekarniku ili medicinskoj sestri.

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

medicinsku sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.

Pogledajte dio 4.

Što se nalazi u ovoj uputi

Što je Docetaxel Accord i za što se koristi

Što morate znati prije nego počnete primjenjivati Docetaxel Accord

Kako primjenjivati Docetaxel Accord

Moguće nuspojave

Kako čuvati Docetaxel Accord

Sadržaj pakiranja i druge informacije

1.

Što je Docetaxel Accord i za što se koristi

Ovaj lijek se zove Docetaxel Accord. Uobičajeni naziv je docetaksel. Docetaksel je tvar koja se dobiva

iz iglica drveta tise.

Docetaksel pripada skupini antitumorskih lijekova, koji se nazivaju taksani.

Docetaxel Accord Vam je propisao liječnik za liječenje karcinoma dojke, posebnih oblika karcinoma

pluća (karcinom nemalih stanica pluća), karcinoma prostate, karcinoma želuca ili karcinoma glave i

vrata:

Za liječenje uznapredovalog karcinoma dojke, docetaksel se primjenjuje sam ili u kombinaciji s

doksorubicinom, trastuzumabom ili kapecitabinom.

Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, docetaksel se

primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.

Za liječenje karcinoma pluća docetaksel se primjenjuje sam ili u kombinaciji s cisplatinom.

Za liječenje karcinoma prostate docetaksel se primjenjuje u kombinaciji s prednizonom ili

prednizolonom.

Za liječenje metastatskog karcinoma želuca docetaksel se primjenjuje u kombinaciji s cisplatinom

i 5-fluoruracilom.

Za liječenje karcinoma glave i vrata docetaksel se primjenjuje u kombinaciji s cisplatinom i 5-

fluorouracilom.

2.

Što morate znati prije nego počnete primjenjivati Docetaxel Accord

Docetaxel Accord se ne smije primijeniti:

ako ste alergični (preosjetljivi) na docetaksel ili neki drugi sastojak lijeka Docetaxel Accord.

ako imate premali broj bijelih krvnih stanica.

ako bolujete od teške bolesti jetre.

Upozorenja i mjere opreza

Prije svake primjene lijeka Docetaxel Accord, obavit ćete krvne pretrage kako bi se provjerilo imate li

dovoljno krvnih stanica te odgovarajuću funkciju jetre kako biste mogli primiti Docetaxel Accord. U

slučaju poremećaja broja bijelih krvnih stanica, moguće je da taj poremećaj uzrokuje vrućicu ili

infekciju.

Obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru ako imate problema s vidom. U

slučaju problema s vidom, naročito zamagljenog vida, trebate odmah otići na pregled očiju i vida.

Obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru ako ste doživjeli alergijsku

reakciju na prethodnu terapiju paklitakselom.

Obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru ako imate problema sa srcem.

Ako Vam se jave akutni problemi ili Vam se pogoršaju postojeći problemi s plućima (vrućica,

nedostatak zraka ili kašalj), molimo odmah obavijestite svog liječnika, bolničkog ljekarnika ili

medicinsku sestru. Moguće je da će Vaš liječnik odmah prekinuti Vaše liječenje.

Od Vas će se tražiti da uzmete premedikaciju koja se sastoji od oralnih kortikosteroida, poput

deksametazona, dan prije primjene lijeka Docetaxel Accord te još dan ili dva nakon toga, kako bi se

smanjile određene nuspojave, koje se mogu pojaviti nakon infuzije lijeka Docetaxel Accord, osobito

alergijske reakcije i zadržavanje tekućine u tijelu (oticanje ruku, stopala, nogu ili povećanje tjelesne

težine).

Tijekom liječenja možda će Vam se dati lijekovi za održavanje broja krvnih stanica.

Docetaxel Accord sadrži alkohol. Razgovarajte sa svojim liječnikom ako ste ovisni o alkoholu, imate

epilepsiju ili oštećenje funkcije jetre. Također pogledajte dio "Docetaxel Accord sadrži etanol

(alkohol)" niže.

Drugi lijekovi i Docetaxel Accord

Obavijestite svog liječnika ili bolničkog ljekarnika ako uzimate ili ste nedavno uzeli bilo koje druge

lijekove, uključujući i one koje ste nabavili bez recepta. Naime, može se dogoditi da u tom slučaju

Docetaxel Accord ili neki drugi lijek neće djelovati prema očekivanju te da postoji veća vjerojatnost

pojave nuspojava.

Količina alkohola u ovom lijeku može promijeniti učinak drugih lijekova.

Trudnoća, dojenje i plodnost

Obratite se svom liječniku za savjet prije nego uzmete bilo koji lijek.

Docetaxel Accord NE SMIJETE primati ako ste trudni, osim ako to liječnik nije izričito propisao.

Ne smijete zatrudnjeti tijekom uzimanja ovog lijeka i morate provoditi učinkovite mjere kontracepcije

tijekom liječenja, jer docetaksel može biti štetan za nerođeno dijete. Ako zatrudnite tijekom liječenja,

odmah obavijestite svog liječnika.

Ne smijete dojiti tijekom liječenja docetakselom.

Muškarcima koji primaju Docetaxel Accord savjetuje se da ne začinju dijete tijekom liječenja i do 6

mjeseci nakon prestanka terapije te da potraže savjet o konzervaciji sperme prije liječenja, jer

docetaksel može utjecati na plodnost muškarca.

Upravljanje vozilima i strojevima

Količina alkohola u ovom lijeku može smanjiti sposobnost upravljanja vozilima ili strojevima.

Količina alkohola u ovom lijeku može oslabiti bolesnikovu sposobnost upravljanja vozilima i rada sa

strojevima.

Docetaxel Accord sadrži etanol (alkohol)

Docetaxel Accord 20 mg/1 ml sadrži

50 vol% bezvodnog etanola (alkohol), odnosno do 395 mg bezvodnog etanola po bočici, što odgovara

količini od 10 ml piva ili 4 ml vina.

Docetaxel Accord 80 mg/4 ml sadrži

50 vol% bezvodnog etanola (alkohol), odnosno do 1,58 g bezvodnog etanola po bočici, što odgovara

količini od 40 ml piva ili 17 ml vina.

Docetaxel Accord 160 mg/8 ml sadrži

50 vol% bezvodnog etanola (alkohol), odnosno do 3,16 g bezvodnog etanola po bočici, što odgovara

količini od 80 ml piva ili 33 ml vina.

Štetno za ljude koji pate od alkoholizma.

Potrebno je uzeti u obzir kod trudnica, dojilja, djece i visokorizičnih skupina, kao što su bolesnici s

bolešću jetre ili epilepsijom.

Količina alkohola u ovom lijeku može utjecati na središnji živčani sustav (dio živčanog sustava koji

uključuje mozak i kralježničnu moždinu).

3.

Kako primjenjivati Docetaxel Accord

Docetaxel Accord će Vam davati zdravstveni radnik.

Preporučena doza

Doza će ovisiti o Vašoj težini i Vašem općem stanju. Liječnik će izračunati površinu Vašeg tijela u

kvadratnim metrima (m

) i odrediti dozu koju trebate primiti.

Način i put primjene

Docetaxel Accord ćete dobiti infuzijom u jednu od vena (intravenska primjena). Infuzija će trajati oko

jedan sat i primit ćete je u bolnici.

Učestalost primjene

Obično ćete primati infuziju svaka tri tjedna.

Vaš liječnik može mijenjati dozu i učestalost primjene lijeka ovisno o rezultatima krvnih pretraga,

Vašem općem stanju i terapijskom odgovoru na Docetaxel Accord. Osobito je važno obavijestiti

liječnika u slučaju proljeva, ranica u ustima, osjećaja utrnulosti ili bockanja u udovima i povišene

temperature te mu pokazati rezultate krvnih pretraga. Na osnovu tih informacija liječnik će odlučiti je

li potrebno smanjiti dozu. U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka obratite se

liječniku ili bolničkom ljekarniku.

4.

Moguće nuspojave

Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.

O mogućim nuspojavama će Vaš liječnik razgovarati s Vama i objasniti Vam rizike i koristi liječenja.

Najčešće prijavljivane nuspojave docetaksela kada se primjenjuje sam su: pad broja crvenih ili bijelih

krvnih stanica, gubitak kose, mučnina, povraćanje, ranice u ustima, proljev i umor.

Težina nuspojava docetaksela može se povećati kada se daje u kombinaciji s drugim

kemoterapeuticima.

Tijekom infuzije u bolnici mogu se javiti sljedeće alergijske reakcije (javljaju se u više od 1 na 10

osoba):

crvenilo praćeno osjećajem vrućine, kožne reakcije, svrbež

stezanje u prsima, otežano disanje

vrućica ili zimica

bol u leđima

nizak krvni tlak.

Također se mogu javiti i teže nuspojave.

Ako ste imali alergijsku reakciju na paklitaksel, možete također doživjeti alergijsku reakciju na

docetaksel, koja može biti teža.

Vaše stanje pomno će nadzirati medicinsko osoblje za vrijeme liječenja. Odmah ih obavijestite ako

zamijetite bilo koju od ovih nuspojava.

Između infuzija docetaksela mogu se pojaviti sljedeće nuspojave, a učestalost može varirati ovisno o

kombinacijama lijekova koje ste primili:

Vrlo često

(javljaju se u više od 1 na 10 osoba):

infekcije, smanjenje broja crvenih krvnih stanica (anemija) ili bijelih krvnih stanica (koje su važne

u borbi protiv infekcija) i krvnih pločica

vrućica: ako imate povišenu temperaturu odmah obavijestite svog liječnika

alergijske reakcije kao što je opisano gore

gubitak apetita (anoreksija)

nesanica

osjećaj utrnulosti ili bockanja ili bol u zglobovima i mišićima

glavobolja

promjene osjeta okusa

upala oka ili povećano suzenje očiju

oticanje uzrokovano lošom limfnom drenažom

nedostatak zraka

curenje iz nosa; upala grla i nosa; kašalj

krvarenje iz nosa

ranice u ustima

nelagoda u trbuhu uključujući mučninu, povraćanje i proljev, zatvor

bolovi u trbuhu

probavne tegobe

gubitak kose: u većini slučajeva trebao bi se vratiti normalan rast kose. U nekim slučajevima

(nepoznata učestalost) zabilježen je trajan gubitak kose

crvenilo i otic

anje dlanova ili tabana koje može uzrokovati ljuštenje kože (ovo se može također

pojaviti na rukama, licu ili tijelu)

promjena boje noktiju koji nakon toga mogu otpasti

bolovi u mišićima; bol u leđima ili bol u kostima

promjene ili izostanak menstruacijskog ciklusa

oticanje ruku, stopala, nogu

umor; ili simptomi nalik gripi

dobitak ili gubitak na težini.

Često

(javljaju se u do 1 na 10 osoba):

oralna kandidijaza

dehidracija

omaglica

oštećenje sluha

pad krvnog tlaka; nepravilni ili brzi srčani otkucaji

zatajenje srca

upala jednjaka

suha usta

otežano ili bolno gutanje

krvarenje

povišeni jetreni enzimi (potrebne redovite krvne pretrage).

Manje često

(javljaju se u do 1 na 100 osoba):

nesvjestica

na mjestu injiciranja: kožne reakcije, flebitis (upala vena) ili oticanje

upala debelog crijeva, tankog crijeva; probušenje crijeva

krvni ugrušci.

Učestalost nije poznata

(ne može se procijeniti iz dostupnih podataka)

:

intersticijska bolest pluća (upala pluća koje uzrokuje kašalj i otežano disanje. Upala pluća se

također može javiti kad se liječenje docetakselom primjenjuje s radioterapijom)

pneumonija (infekcija pluća)

plućna fibroza (ožiljci i zadebljanja na plućima praćeno nedostatkom zraka)

zamagljen vid uzrokovan oticanjem mrežnice oka (cistoidni edem makule)

smanjenje razina natrija, kalija, magnezija i/ili kalcija u krvi (poremećaji ravnoteže elektrolita).

ventrikularna aritmija ili ventrikularna tahikardija (koja se manifestira kao nepravilni i/ili ubrzani

otkucaji srca, teški nedostatak zraka, omaglica i/ili nesvjestica). Neki od ovih simptoma mogu biti

ozbiljni. Odmah obavijestite svog liječnika ako se to dogodi.

reakcije na mjestu primjene injekcije koje se javljaju na mjestu prethodne reakcije.

Prijavljivanje nuspojava

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

medicinsku sestru. To uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.

Nuspojave možete prijaviti izravno putem nacionalnog sustava prijavljivanja: navedenog u Dodatku

V. Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Docetaxel Accord

Lijek čuvajte izvan pogleda i dohvata djece.

Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i

naljepnici bočice iza oznake Rok valjanosti. Rok valjanosti odnosi se na zadnji dan navedenog

mjeseca.

Ne čuvati na temperaturi iznad 25°C. Čuvati u originalnom pakiranju, radi zaštite od svjetlosti.

Upotrijebite bočicu lijeka odmah nakon otvaranja. Ako se lijek ne primjeni odmah, vrijeme i uvjeti

čuvanja lijeka u primjeni su odgovornost korisnika.

S mikrobiološkog stajališta, razrjeđivanje se mora odvijati u kontroliranim i aseptičkim uvjetima.

Nakon dodavanja lijeka u infuzijsku vrećicu, odmah upotrijebite pripremljenu otopinu. Ako se otopina ne

upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u uporabi su odgovornost korisnika, a ne bi smjeli biti

duži od 6 sati pri temperaturi ispod 25

C, uključujući u to i jednosatnu infuziju

Fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do

48 sati u ne-PVC vrećici kada se čuvaju pri temperaturi od 2ºC do 8ºC.

Pripremite infuzijsku otopinu na način na koji je to preporučeno. Neka infuzijska otopina ne bude

priključena na infuzijski set više od 8 sati na temperaturi od

25°C.

Infuzijska otopina docetaksela je prezasićena, stoga tijekom vremena može doći do kristalizacije. Ako

se kristali pojave, otopina se više ne smije koristiti, te ju je potrebno baciti.

Nikada nemojte nikakve lijekove bacati u otpadne vode. Pitajte svog ljekarnika kako baciti lijekove koje

više ne koristite. Ove će mjere pomoći u očuvanju okoliša.

6.

Sadržaj pakiranja i druge informacije

Što Docetaxel Accord sadrži

Djelatna tvar je docetaksel. Jedan ml koncentrata za otopinu za infuziju sadržava 20 mg

docetaksela.

Jedna bočica od 1 ml koncentrata sadržava 20 mg docetaksela.

Jedna bočica od 4 ml koncentrata sadržava 80 mg docetaksela.

Jedna bočica od 8 ml koncentrata sadržava 160 mg docetaksela.

Pomoćne tvari su polisorbat 80, etanol bezvodni (vidjeti dio 2) i citratna kiselina, bezvodna.

Kako Docetaxel Accord izgleda i sadržaj pakiranja

Docetaxel Accord koncentrat za otopinu za infuziju je bistra svijetložuta do smeđežuta otopina.

Docetaxel Accord 20 mg/1 ml se isporučuje u prozirnoj staklenoj bočici od 5 ml, s fluorotec plus

gumenim čepom, aluminijskim zatvaračem i narančastom „flip-off „ zaštitnom kapicom

Docetaxel Accord 80 mg/4 ml se isporučuje u prozirnoj staklenoj bočici od 5 ml , s fluorotec plus

gumenim čepom, aluminijskim zatvaračem i crvenom „flip-off „ zaštitnom kapicom

Docetaxel Accord 160 mg/8 ml se isporučuje u prozirnoj staklenoj bočici od 10 ml, s fluorotec plus

gumenim čepom, aluminijskim zatvaračem i crvenom „flip-off „ zaštitnom kapicom

Pakiranje:

Jedno pakiranje sadrži po jednu bočicu s 1 ml koncentrata,

Jedno pakiranje sadrži po jednu bočicu s 4 ml koncentrata.

Jedno pakiranje sadrži po jednu bočicu s 8 ml koncentrata.

Nositelj odobrenja za stavljanje lijeka u promet

Accord Healthcare Limited

Sage House

319, Pinner Road

North Harrow, Middlesex HA1 4HF

Ujedinjeno Kraljevstvo

Ova uputa je zadnji puta revidirana u.

Drugi izvori informacija

Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za

lijekove: http://www.ema.europa.eu.

Sljedeće informacije namijenjene su samo zdravstvenim radnicima:

UPUTE ZA PRIPREMU ZA PRIMJENU DOCETAXEL ACCORD KONCENTRATA ZA

OTOPINU ZA INFUZIJU

Važno je pročitati cijeli sadržaj ove upute prije pripreme Docetaxel Accord infuzijske otopine.

Preporuke za sigurno rukovanje

Docetaksel je antineoplastična tvar te se njime, kao što je slučaj i sa svim ostalim potencijalno

toksičnim spojevima, potreban je oprez prilikom rukovanja i pripreme otopina koje ga sadrže.

Preporuča se uporaba rukavica.

Ako Docetaxel Accord koncentrat ili infuzijska otopina dođu u dodir s kožom, to mjesto odmah

temeljito isprati sapunom i vodom. Ako dođe u dodir sa sluznicom, odmah temeljito isperite vodom.

Priprema za intravensku primjenu

Priprema infuzijske otopine

NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s

ovim lijekom (Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadržava samo 1

bočicu).

NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s

ovim lijekom (Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadržava samo 1

bočicu).

NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s

ovim lijekom (Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadržava samo 1

bočicu).

Docetaxel Accord koncentrat za otopinu za infuziju NE ZAHTIJEVA prethodno

razrjeđivanje s otapalom i spreman je za dodavanje infuzijskoj otopini.

Svaka bočica namijenjena je za jednokratnu primjenu te se treba primijeniti odmah nakon

otvaranja. Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u primjeni su odgovornost

korisnika. Ponekad je potrebno upotrijebiti više od jedne bočice koncentrata

za otopinu za

infuziju

kako bi se

dobila potrebna doza za bolesnika. Primjerice, za dozu od 140 mg

docetaksela bilo bi potrebno 7 ml docetaksel koncentrata za otopinu.

Aseptički izvucite potreban volumen koncentrata za otopinu za infuziju koristeći graduiranu

štrcaljku.

U bočici lijeka DocetaxelAccord koncentracija docetaksela iznosi 20 mg/ml.

Injicirati jednokratnom injekcijom (jedno injiciranje) u infuzijsku vrećicu od 250 ml koja sadrži ili

5%-tnu

otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.

je potrebna doza veća od 190 mg docetaksela, upotrijebite veći volumen infuzijskog

sredstva,

tako da koncentracija docetaksela ne prelazi 0,74 mg/ml.

Promiješajte sadržaj infuzijske vrećice ručno, polukružnim (ljuljajućim) pokretima.

S mikrobiološkog stajališta, razrijeđivanje se mora odvijati u kontroliranim i aseptičkim uvjetima,

a infuzijsku otopinu je potrebno upotrijebiti odmah. Ako se ne upotrijebi odmah, vrijeme i uvjeti

čuvanja lijeka u primjeni su odgovornost korisnika.

Nakon dodavanja u infuzijsku vrećicu kao što je propisano, infuzijska otopina docetaksela stabilna

je 6 sati pri temperaturi do 25°C. Infuzijska otopina treba se upotrijebiti unutar 6 sati (uključujući

u to i jednosatnu intravensku infuziju bolesniku).

Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu

dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8°C.

Infuzijska otopina docetaksela je prezasićena, stoga, tijekom vremena može doći do kristalizacije.

Ako se kristali pojave, otopina se više ne smije koristiti te ju je potrebno baciti.

Kao što je slučaj sa svim parenterainim pripravcima, infuzijsku otopinu je potrebno

vizualno

provjeriti prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.

Zbrinjavanje

Sav otpadni materijal korišten za razrjeđivanje ili primjenu lijeka treba se zbrinuti sukladno

standardnim postupcima. Nikada nemojte nikakve lijekove bacati u otpadne vode. Pitajte svog

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

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

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

2-10-2018

Docetaxel Teva (Teva B.V.)

Docetaxel Teva (Teva B.V.)

Docetaxel Teva (Active substance: Docetaxel) - Centralised - Yearly update - Commission Decision (2018)6463 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

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