Levetiracetam Accord

Glavna informacija

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

Dokument

Lokalizacija

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

Terapeutski informacija

  • Terapijska grupa:
  • Anti-epilectics
  • Područje terapije:
  • Epilepsija
  • Terapijske indikacije:
  • Levetiracetam je indiciran kao monoterapija u liječenju parcijalnih napadaja s ili bez sekundarne generalizacije u bolesnika od 16 godina starosti s novodijagnosticiranom epilepsijom.

Druge informacije

Status

  • Izvor:
  • EMA - European Medicines Agency
  • Status autorizacije:
  • odobren
  • Broj odobrenja:
  • EMEA/H/C/002290
  • Datum autorizacije:
  • 03-10-2011
  • EMEA koda:
  • EMEA/H/C/002290
  • Zadnje ažuriranje:
  • 01-03-2018

Izvješće o ocjeni javnog

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/857145/2015

EMEA/H/C/002290

EPAR, sažetak za javnost

Levetiracetam Accord

levetiracetam

Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek

Levetiracetam Accord. Objašnjava kako je Odbor za za humanu uporabu (CHMP) ocijenio lijek kako bi

preporučio njegovo odobrenje u EU-u te uvjete za primjenu lijeka Levetiracetam Accord.

Što je Levetiracetam Accord?

Levetiracetam Accord je lijek koji sadržava djelatnu tvar levetiracetam. Dostupan je u obliku tableta

(250 mg, 500 mg, 750 mg i 1000 mg).

Levetiracetam Accord „generički je lijek”. To znači da je Levetiracetam Accord sličan „referentnom

lijeku” koji je već odobren u Europskoj uniji pod nazivom Keppra. Više informacija o generičkim

lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje

Za što se koristi Levetiracetam Accord?

Levetiracetam Accord može se primjenjivati samostalno u bolesnika od 16. godine života s

novodijagnosticiranom epilepsijom, u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili

bez nje. To je vrsta epilepsije kod koje pretjerana električna aktivnost u jednom dijelu mozga uzrokuje

simptome kao što su iznenadni trzaji jednog dijela tijela, oštećenje sluha, njuha ili vida, otupljenost ili

iznenadni osjećaj straha. Sekundarna generalizacija događa se kad se pretjerana aktivnost proširi na

cijeli mozak.

Levetiracetam Accord kao dodatna terapija uz druge antiepileptike u liječenju:

parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u dojenčadi od prvog mjeseca

života;

miokloničkih napadaja (kratki, snažni trzaji mišića ili skupine mišića) u bolesnika starijih od 12.

godine života s juvenilnom miokloničkom epilepsijom;

Levetiracetam Accord

EMA/857145/2015

Stranica 2/3

primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u

bolesnika starijih od 12. godine života s idiopatskom generaliziranom epilepsijom (vrsta epilepsije

za koju se vjeruje da je nasljedna).

Lijek se može nabaviti samo uz recept.

Kako se Levetiracetam Accord koristi?

Kad se Levetiracetam Accord samostalno uzima, početna doza je 250 mg dvaput dnevno, a nakon dva

tjedna povećava se na 500 mg dvaput dnevno. Doza se u intervalima od dva tjedna može dodatno

povećati do najviše 1500 mg dvaput dnevno na temelju odgovora bolesnika.

Kada se Levetiracetam Accord dodaje drugom antiepileptičkom liječenju, početna doza u bolesnika od

12. godine života koji imaju više od 50 kg iznosi 500 mg dvaput dnevno. Dnevna doza može se

povećati do 1500 mg dvaput dnevno. Za bolesnike koji imaju manje od 50 kg, doza ovisi o tjelesnoj

težini. Bolesnicima koji ne mogu uzimati tablete potrebno je dati otopinu koja sadržava levetiracetam.

Manje doze koriste se u bolesnika koji imaju probleme s bubrezima (na primjer stariji bolesnici).

Levetiracetam Accord tablete gutaju se s tekućinom.

Kako djeluje Levetiracetam Accord?

Djelatna tvar levetiracetam u lijeku Levetiracetam Accord lijek je protiv epilepsije. Epilepsiju uzrokuje

pretjerana električna aktivnost u mozgu. Točno djelovanje levetiracetama nije jasno, ali povezuje se s

proteinom pod nazivom sinaptički vezikularni protein 2A koji sudjeluje u otpuštanju kemijskih glasnika

iz živčanih stanica. To lijeku Levetiracetam Accord pomaže da stabilizira električnu aktivnost u mozgu i

spriječi napadaje.

Kako je Levetiracetam Accord ispitivan?

Budući da je Levetiracetam Accord generički lijek, ispitivanja na ljudima bila su ograničena na

utvrđivanje činjenice je li lijek bioekvivalentan referentnom lijeku Keppra. Dva su lijeka

bioekvivalentna ako proizvode iste razine djelatne tvari u tijelu.

Koje su koristi i rizici lijeka Levetiracetam Accord?

Budući da je Levetiracetam Accord generički lijek te je bioekvivalentan referentnom lijeku, smatra se

da su njegove koristi i rizici isti kao i oni referentnog lijeka.

Zašto je lijek Levetiracetam Accord odobren?

Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima

EU-a, lijek Levetiracetam Accord dokazao usporedivu kakvoću te da je bioekvivalentan/usporediv s

Kepprom. Stoga je stav CHMP-a da korist nadmašuje identificiran rizik, kao i za Keppru. Odbor je

preporučio davanje odobrenja za stavljanje lijeka Levetiracetam Accord u promet.

Levetiracetam Accord

EMA/857145/2015

Stranica 3/3

Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita

primjena lijeka Levetiracetam Accord?

Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i

učinkovite primjene lijeka Levetiracetam Accord nalaze se također u sažetku opisa svojstava lijeka i u

uputi o lijeku.

Ostale informacije o lijeku Levetiracetam Accord

Europska komisija izdala je odobrenje za stavljanje lijeka Levetiracetam Accord u promet koje vrijedi

na prostoru Europske unije od 3. listopada 2011.

Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Levetiracetam Accord

nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human

medicines/European Public Assessment Reports. Više informacija o liječenju lijekom Levetiracetam

Accord pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili

ljekarniku.

Cjelovito izvješće EPAR za referentni lijek također se nalazi na internetskim stranicama Agencije.

Sažetak je posljednji put ažuriran 06.2016.

Uputu o lijeku

B. UPUTA O LIJEKU

Uputa o lijeku: Informacije za bolesnika

Levetiracetam Accord 250 mg filmom obložene tablete

Levetiracetam Accord 500 mg filmom obložene tablete

Levetiracetam Accord 750 mg filmom obložene tablete

Levetiracetam Accord 1000 mg filmom obložene tablete

levetiracetam

Pažljivo pročitajte cijelu uputu prije nego Vi ili Vaše dijete počnete uzimati ovaj lijek jer sadrži

Vama važne podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

Ako imate dodatnih pitanja, obratite se 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 Levetiracetam Accord i za što se koristi

Što morate znati prije nego počnete uzimati Levetiracetam Accord

Kako uzimati Levetiracetam Accord

Moguće nuspojave

Kako čuvati Levetiracetam Accord

Sadržaj pakiranja i druge informacije

1.

Što je Levetiracetam Accord i za što se koristi

Levetiracetam Accord jest antiepileptik (lijek koji se koristi u liječenju epileptičkih napadaja).

Levetiracetam Accord se koristi:

samostalno u odraslih i adolescenata od 16. godine života s novodijagnosticiranom epilepsijom, u

liječenju određenog oblika epilepsije. Epilepsija je stanje u kojem bolesnici imaju ponavljane

epileptičke napadaje. Levetiracetam se koristi za oblik epilepsije u kojem napadaji započinju u

jednoj strani mozga, ali se nakon toga mogu proširiti na veće područje u obje strane mozga

(parcijalni

napadaj

sekundarne

generalizacije).

Vaš

liječnik

propisao

levetiracetam kako bi se smanjio broj napadaja

kao dodatna terapija uz druge antiepileptike u liječenju:

parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata,

djece i dojenčadi od prvog mjeseca života

miokloničkih napadaja (kratki, iznenadni trzaji mišića ili skupine mišića) u odraslih i

adolescenata starijih od 12. godine života s juvenilnom miokloničkom epilepsijom

primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gibitak

svijesti)

odraslih

adolescenata

starijih

godine

života

idiopatskom

generaliziranom epilepsijom (oblik epilepsije za koji se smatra da je genetski uvjetovan).

2.

Što morate znati prije nego počnete uzimati Levetiracetam Accord

Nemojte uzimati Levetiracetam Accord

ako ste alergični na levetiracetam, derivate pirolidona ili neki drugi sastojak ovog lijeka (naveden

u dijelu 6.).

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego uzmete Levetiracetam Accord

ako patite od bubrežnih problema, slijedite upute svog liječnika koji će odlučiti treba li prilagoditi

Vašu dozu.

ako primijetite usporen rast ili neočekivan razvoj djeteta u pubertetu, obavijestite svog liječnika.

mali

broj

ljudi

liječenih

antiepilepticima

što

Levetiracetam Accord imali su misli o

samoozljeđivanju ili samoubojstvu. Ako imate bilo kakve simptome depresije i/ili samoubilačke

ideje, obavijestite svog liječnika.

Djeca i adolescenti

U djece i adolescenata mlađih od 16 godina Levetiracetam Accord se ne primjenjuje samostalno

(monoterapija).

Drugi lijekovi i Levetiracetam Accord

Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje

druge lijekove.

Ne uzimajte makrogol (lijek koji se koristi kao laksativ) jedan sat prije i jedan sat nakon uzimanja

levetiracetama zbog toga što se može smanjiti učinak levetiracetama.

Trudnoća i dojenje

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

liječniku za savjet prije nego uzmete ovaj lijek.

Levetiracetam Accord se ne smije uzimati tijekom trudnoće, osim ako je to neophodno. Ne može se u

potpunosti isključiti rizik uzrokovanja urođenih defekata za Vaše nerođeno dijete. U ispitivanjima na

životinjskim modelima, utvrđeno je da je Levetiracetam Accord povezan s neželjenim reproduktivnim

učincima kada je primjenjivan u dozama većim nego što bi bile potrebne za kontrolu Vaših napadaja.

Tijekom liječenja ne preporučuje se dojenje.

Upravljanje vozilima i strojevima

Ako vozite ili upravljate alatima ili vozilima potreban je oprez jer se pri uzimanju lijeka Levetiracetam

Accord može javiti osjećaj pospanosti. To se češće javlja na početku liječenja ili nakon povećanja doze.

Ne smijete voziti ili upravljati strojevima dok se ne utvrdi da uzimanje lijeka Levetiracetam Accord ne

utječe na Vaše sposobnosti za to.

Levetiracetam Accord 750 mg tablete sadrže sunset yellow FCF (E110).

Bojilo

sunset yellow

FCF (E110) može uzrokovati alergijske reakcije. Druge jačine Levetiracetam

tableta me sadrže ovaj sastojak.

3.

Kako uzimati Levetiracetam Accord

Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik. Provjerite s liječnikom ili

ljekarnikom ako niste sigurni.

Uzmite onoliko tableta koliko je liječnik propisao.

Levetiracetam Accord se mora uzimati dva puta na dan, jednom ujutro i jednom navečer, u približno isto

vrijeme svaki dan.

Monoterapija

Doza za odrasle i adolescente (od 16. godine života)

Uobičajena doza: između 1000 mg i 3000 mg svaki dan.

Kad prvi put počnete uzimati Levetiracetam Accord, liječnik će Vam propisati

manju dozu

(500 mg

svaki dan)

tijekom 2 tjedna prije davanja najmanje uobičajene doze od 1000 mg.

Dodatna terapija

Doza u odraslih i adolescenata (12 do 17 godina) koji imaju 50 kg ili više:

Uobičajena doza: između 1000 mg i 3000 mg svaki dan.

Na primjer: ako je Vaša dnevna doza 1000 mg, mogli biste uzeti 2 tablete od 250 mg ujutro i 2

tablete od 250 mg navečer.

Doza u dojenčadi (1 mjesec do 23 mjeseca), djece (2 do 11 godina) i adolescenata (12 do 17

godina) koji imaju manje od 50 kg

Liječnik će propisati najprikladniji farmaceutski oblik levetiracetama sukladno dobi, tjelesnoj

težini i dozi.

Oralna otopina je prikladniji farmaceutski oblik za primjenu u dojenčadi i djece mlađe od 6

godina, djece i adolescenata (6-17 godina) tjelesne težine manje od 50 kg te kada se tabletama ne

može postići točno doziranje.

Način primjene

Progutajte

Levetiracetam

Accord

tablete

dovoljnom

količinom

tekućine

(npr.

čašom

vode).

Levetiracetam Accord možete uzeti sa ili bez hrane.

Trajanje liječenja

Levetiracetam Accord se koristi za kronično liječenje. Trebate nastaviti liječenje Levetiracetam

Accordom onoliko dugo koliko je liječnik odredio.

Nemojte prekinuti liječenje bez savjeta liječnika jer to može pojačati napadaje

Ako uzmete više Levetiracetam Accord nego što ste trebali

Moguće

nuspojave

predoziranja

levetiracetamom

pospanost,

uznemirenost,

agresija,

smanjena

pozornost, smetnje disanja i koma.

Obavijestite liječnika ako ste uzeli više tableta nego što ste trebali. Vaš će liječnik odrediti najbolji

mogući način liječenja predoziranja.

Ako ste zaboravili uzeti Levetiracetam Accord

Obavijestite liječnika ako ste zaboravili uzeti jednu ili više doza.

Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.

Ako prestanete uzimati Levetiracetam Accord

prekidate

liječenje

Levetiracetam

Accordom, prekid mora biti postupan kako bi se izbjeglo

pojačanje napadaja.

Ako Vaš liječnik odluči prekinuti liječenje Levetiracetam Accordom, uputit će Vas kako postupno

prekinuti liječenje Levetiracetam Accordom.

U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.

4.

Moguće nuspojave

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

Najčešće prijavljene nuspojave su nazofaringitis, izrazita pospanost, glavobolja, umor i omaglica. Na

početku liječenja ili nakon povećanja doze nuspojave, poput pospanosti, umora i omaglice, mogu se

javiti češće. Te bi se nuspojave vremenom trebale smanjiti.

Vrlo često:

može zahvatiti više od 1 na 10 osoba

upala nosa i ždrijela;

somnolencija (pospanost), glavobolja.

Često:

može zahvatiti do 1 na 10 osoba

anoreksija (gubitak apetita);

depresija, netrpeljivost ili agresivnost, tjeskoba, nesanica, nervoza ili razdražljivost;

konvulzije, poremećaj ravnoteže, omaglica (osjećaj nestabilnosti), letargija (nedostatak energije i

elana), tremor (nevoljno drhtanje);

vrtoglavica (osjećaj vrtnje);

kašalj;

bol u trbuhu, proljev, dispepsija (probavne tegobe), povraćanje, mučnina;

osip;

astenija/umor (zamaranje).

Manje često

: može zahvatiti do 1 na 100 osoba

smanjen broj krvnih pločica, smanjen broj bijelih krvnih stanica;

gubitak tjelesne težine, povećanje tjelesne težine;

pokušaj samoubojstva i suicidalne misli, mentalni poremećaj, poremećaj ponašanja, halucinacije,

srditost,

smetenost,

napadaj

panike,

emocionalna

nestabilnost/promjene

raspoloženja,

uznemirenost;

amnezija (gubitak pamćenja), smetnje pamćenja (zaboravljivost), poremećaj koordinacije/ataksija

(poremećaj

koordinacije

pokreta),

parestezije

(trnci),

smetnje

koncentraciji

(gubitak

koncentracije);

diplopija (dvoslike), zamagljen vid;

povišene/promijenjene vrijednosti testova jetrene funkcije;

gubitak kose, ekcem, svrbež;

slabost mišića, mijalgija (bol u mišićima);

ozljeda.

Rijetko

: može zahvatiti do 1 na 1000 osoba

infekcija;

smanjen broj svih vrsta krvnih stanica;

tjelesne težine alergijske reakcije (DRESS, anafilaktička reakcija [teška i ozbiljna alergijska

reakcija], angioedem [oticanje lica, usana, jezika i grla];

snižena koncentracija natrija u krvi;

samoubojstvo,

poremećaj

osobnosti

(problemi

ponašanju),

poremećaj

mišljenja

(sporo

razmišljanje, nemogućnost koncentriranja);

nekontrolirani mišićni grčevi koji zahvaćaju glavu, trup i ekstremitete, teškoće u kontroliranju

pokreta, hiperkinezija (hiperaktivnost);

upala gušterače;

zatajenje jetre, hepatitis;

crvenilo kože koje može tvoriti mjehuriće i izgledati kao male mete (sa središnjim tamnim

točkama okruženim bljeđim područjem i tamnim prstenom oko ruba) (

erythema multiforme

), jako

rasprostranjen osip s mjehurma i kožom koja se ljušti, osobito oko usta, nosa, očiju i genitalija

Stevens-Johnsonov sindrom

), i mnogo teži oblik koji uzrokuje ljuštenje kože na više od 30%

površine tijela (

toksična epidermalna nekroliza

Prijavljivanje nuspojava

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

To 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 Levetiracetam Accord

Lijek čuvajte izvan pogleda i dohvata djece.

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

iza oznake Rok valjanosti i „EXP”. Rok valjanosti odnosi se na zadnji dan navedenog

mjeseca.

Ovaj lijek ne zahtijeva posebne uvjete čuvanja.

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 druge informacije

Što Levetiracetam Accord sadrži

Djelatna tvar je levetiracetam.

Jedna filmom obložena tableta sadrži 250 mg, 500 mg, 750 mg ili 1000 mg levetiracetama.

Sastojci u jezgri tablete su:

umrežena karmelozanatrij, povidon K-30, bezvodni koloidni silicijev dioksid, magnezijev stearat

(E470b).

Film ovojnica sadrži:

250 mg:

poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk

500 mg:

poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, žuti željezov oksid (E 172)

750 mg:

poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk, crveni željezov oksid (E 172), sunset

yellow FCF (E110)

1000 mg:

poli(vinilni alkohol), titanijev dioksid (E171), makrogol, talk

Kako Levetiracetam Accord izgleda i sadržaj pakiranja

250 mg:

Bijela do gotovo bijela, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 64” i

razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.

500 mg:

Žuta, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 65” i razdjelnom crtom na

jednoj strani, te bez oznaka na drugoj strani.

750 mg:

Ružičasta, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 66” i razdjelnom

crtom na jednoj strani, te bez oznaka na drugoj strani.

1000 mg:

Bijela do gotovo bijela, ovalna, bikonveksna filmom obložena tableta s utisnutom oznakom „L 67” i

razdjelnom crtom na jednoj strani, te bez oznaka na drugoj strani.

Levetiracetam Accord filmom obložene tablete 250 mg, 500 mg, 750 mg i 1000 mg se pakiraju u PVC-

Al blister pakiranja. Blisteri se dalje pakiraju u kutije s Uputama o lijeku te sadrže 10, 20, 30, 50, 60,

100 i 200 tableta po pakiranju. Osim toga, tablete su također dostupne u blisterima djeljivim na

jedinične doze za pakiranja od 30x1, 60x1 i 100x1 tableta.

Na tržištu se ne moraju nalaziti sve veličine pakiranje.

Nositelj odobrenja za stavljanje lijeka u promet i proizvođač:

Accord Healthcare Limited

Sage house, 319 Pinner Road,

North Harrow , HA1 4HF

Middlesex

Ujedinjeno Kraljevtsvo

Ova uputa je zadnji puta revidirana u {mjesec/GGGG}

Drugi izvori informacija

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

http://www.ema.europa.eu

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