Tramal 200 mg tablete

Glavna informacija

  • Trgovački naziv:
  • Tramal 200 mg tablete s produljenim oslobađanjem
  • Doziranje:
  • 200 mg
  • Farmaceutski oblik:
  • tableta s produljenim oslobađanjem
  • Sastav:
  • Urbroj: jedna tableta s produljenim oslobađanjem sadrži 200 mg tramadolklorida
  • Tip recepta:
  • na recept, u ljekarni neponovljivi recept
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • alopatski lijek
  • Proizveden od:
  • Stada Arzneimittel AG, Bad Vilbel, Njemačka

Dokument

Lokalizacija

  • Na raspolaganju u:
  • Tramal 200 mg tablete s produljenim oslobađanjem
    Hrvatska
  • Jezik:
  • hrvatski

Terapeutski informacija

  • Proizvod sažetak:
  • Pakiranje: 30 tableta u blisteru, u kutiji [HR-H-505350700-01]; 50 tableta u blisteru, u kutiji [HR-H-505350700-02]; 60 tableta u blisteru, u kutiji [HR-H-505350700-03] Urbroj: 381-12-01/38-17-07

Druge informacije

Status

  • Izvor:
  • HALMED Agencija za lijekove i medicinske proizvode - Agency for medicinal products and medical devices of Croatia
  • Broj odobrenja:
  • HR-H-505350700
  • Datum autorizacije:
  • 15-02-2017
  • Zadnje ažuriranje:
  • 05-06-2018

Uputu o lijeku

Uputa o lijeku: Informacije za bolesnika

Tramal 50 mg tablete s produljenim oslobaĎanjem

Tramal 100 mg tablete s produljenim oslobaĎanjem

Tramal 150 mg tablete s produljenim oslobaĎanjem

Tramal 200 mg tablete s produljenim oslobaĎanjem

tramadolklorid

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

podatke.

Sačuvajte ovu uputu. Možda ćete je trebati ponovno pročitati.

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

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

su njihovi znakovi bolesti jednaki Vašima.

Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti Vašeg 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 su Tramal tablete i za što se koriste?

Što morate znati prije nego počnete uzimati Tramal tablete?

Kako uzimati Tramal tablete?

Moguće nuspojave

Kako čuvati Tramal tablete?

Sadržaj pakiranja i druge informacije

1.

Što su Tramal tablete i za što se koriste?

Tramal pripada skupini lijekova koji se nazivaju analgetici.

Djelatna tvar u ovom lijeku je tramadol, koji pripada skupini opioida koji djeluju na centralni

živčani sustav. Ublažava bol djelovanjem na živčane stanice leđne moždine i mozga.

Tramal se koristi u liječenju umjereno jake do jake boli.

Što morate znati prije nego počnete uzimati Tramal tablete?

Nemojte uzimati Tramal:

ako ste alergični na tramadol ili neku od pomoćnih tvari

u slučaju akutnog trovanja alkoholom, tabletama za spavanje, lijekovima protiv bolova

(analgeticima) ili drugim psihotropnim lijekovima (lijekovi koji djeluju na raspoloženje i

emocije)

ako uzimate MAO inhibitore (lijekovi koji se uzimaju kod depresije) ili ako ste ih

uzimali tijekom 14 dana prije uzimanja Tramal tablete s produljenim oslobađanjem.

ako bolujete od epilepsije i bolest nije adekvatno kontrolirana liječenjem

kao zamjena u liječenju sindroma ustezanja

Upozorenja i mjere opreza

Obratite se svom liječniku prije nego uzmete Tramal tablete:

ako smatrate da ste ovisni o drugim lijekovima protiv bolova (opioidima)

ako bolujete od poremećaja svijesti (ako osjećate da ćete se onesvijestiti)

ako ste u stanju šoka (hladan znoj mogao bi biti znak tog stanja)

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ako bolujete od povišenog tlaka u mozgu (moguća posljedica povrede glave ili moždane

bolesti)

ako imate poteškoća s disanjem

ako bolujete od epilepsije ili imate napadaje, jer se rizik od napadaja može povećati

ako bolujete od bolesti jetre ili bubrega

Zabilježeni su slučajevi epileptičkih napadaja kod pacijenata koji su uzimali preporučene doze

tramadola. Opasnost se može povećati ako se prekorači preporučena dnevna doza od 400 mg

tramadola.

Ovaj lijek može dovesti do fizičke i psihičke ovisnosti. Ako se ovaj lijek uzima kroz duže vrijeme,

njegov učinak se može umanjiti (razvijanje tolerancije), te se moraju uzeti veće doze. Kod pacijenata

koji imaju sklonost zlouporabi ili stvaranju ovisnosti prema lijeku, Tramal se smije primjenjivati samo

kratko vrijeme i uz strog nadzor liječnika.

Obavijestite Vašeg liječnika ukoliko se jedan od ovih problema pojavi za vrijeme liječenja Tramalom

ili ako su Vam se ranije javljali.

Drugi lijekovi i Tramal

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

druge lijekove.

Tramal se ne smije koristiti s MAO inhibitorima (lijekovi koji se uzimaju kod depresije).

Analgetski učinak Tramala mogao bi oslabiti, a dužina trajanja djelovanja skratiti ukoliko uzimate

lijekove koji sadrže neku od navedenih djelatnih tvari:

karbamazepin (lijek koji se koristi kod epileptičkih napada)

ondasetron (lijek koji se koristi kod mučnine)

Liječnik će Vam reći da li je potrebno da uzimate Tramal i u kojoj dozi.

Rizik od nuspojava se povećava:

ako uzimate lijekove za smirenje, lijekove za spavanje, druge lijekove protiv boli kao što su

morfij i kodein (ako se uzimaju i za ublažavanje kašlja) i alkohol za vrijeme uzimanja

Tramadola.

Možete se osjećati omamljeno ili kao da ćete se onesvijestiti. Ukoliko se to

dogodi, obavijestite Vašeg liječnika.

ako uzimate lijekove koji mogu izazvati napadaje, kao što su određeni antidepresivi ili

antipsihotici. Rizik od napadaja se može povećati kod istodobnog uzimanja Tramala.Vaš

liječnik će Vam reći da li je Tramal prikladan za Vas.

ako uzimate određene antidepresive, Tramal može stupiti u interakcije s tim lijekovima i

dovesti do simptoma kao što su: nevoljno, ritmičko stezanje mišića, uključujući mišiće koji

pokreću oko, uznemirenost, prekomjerno znojenje, nevoljno drhtanje, pojačanje refleksa,

pojačanje napetosti mišića, povećanje temperature tijela iznad 38°C.

ako u isto vrijeme s Tramalom uzimate kumarinska sredstva protiv zgrušavanja krvi (npr.

varfarin). Ti lijekovi mogu imati utjecaja na zgrušavanje krvi i može se pojaviti krvarenje.

Tramal s hranom i alkoholom

Nemojte piti alkohol za vrijeme uzimanja Tramala, jer njegov učinak može biti povećan. Hrana ne

utječe na ovaj lijek.

Trudnoća, dojenje i plodnost

Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate trudnoću, obratite se Vašem

liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.

Ako ste trudni, nemojte uzimati Tramal.

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Tramadol prolazi kroz posteljicu.

Ne postoji dovoljno dokaza o neškodljivosti tramadola tijekom

trudnoće u ljudi.

Dugotrajna primjena Tramala za vrijeme trudnoće može dovesti do simptoma ustezanja u

novorođenčadi.

Nemojte uzimati Tramal tijekom dojenja.

Tramadol se u malim količinama izlučuje u mlijeko. Nakon jednokratne primjene tramadola obično

nije potrebno prekidati dojenje.

Na temelju podataka o primjeni tramadola u ljudi, smatra se da tramadol ne utječe na plodnost žena ili

muškaraca.

Upravljanje vozilima i strojevima

Tramal može uzrokovati omaglicu, omamljenost i zamućen vid, te negativno utjecati na Vaše reakcije

upravljanja vozilima i strojevima. Ako osjećate da Tramal utječe na Vas, ne vozite automobil ili neko

drugo vozilo i ne upotrebljavajte električne alate ili strojeve.

Ovaj lijek sadrži laktozu. Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s

liječnikom prije uzimanja ovog lijeka.

3.

Kako uzimati Tramal tablete?

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

liječnikom ili ljekarnikom ako niste sigurni.

Dozu treba prilagoditi intenzitetu Vaše boli i osobnoj osjetljivosti na bol. U načelu, treba uzeti najnižu

dozu. Nemojte uzeti više od 400 mg Tramala dnevno, osim ako Vam liječnik nije tako propisao.

Ukoliko liječnik ne propiše drugačije, uobičajena doza je:

Odrasli i adolescenti stariji od 12 godina

Uobičajena početna doza iznosi 50-100 mg dva puta na dan, ujutro i uvečer. Ako bol dovoljno ne

popusti, doza se može povećati na jednu tabletu od 150 mg ili na jednu tabletu od 200 mg dva puta na

dan.

Dnevna doza od 400 mg tramadolklorida općenito se ne bi trebala prekoračiti. No, mnogo veće doze

mogu se pokazati potrebnima u liječenju bolova kod tumora i jakih postoperativnih bolova.

Djeca

Tramal tablete s produljenim oslobađanjem nije prikladan za uporabu kod djece mlađe od 12 godina

Stariji bolesnici

U starijih bolesnika (iznad 75 godina) izlučivanje tramadola se može produljiti. Ako se to odnosi na

Vas, Vaš liječnik može odrediti produljenje razmaka između pojedinih doza.

Bolesnici s jetrenim ili bubrežnim oštećenjem/ bolesnici na dijalizi

Bolesnici s teškim oštećenjem funkcije jetre i/ili bubrega ne smiju uzimati Tramal. U slučaju blagog ili

umjerenog oštećenja funkcije, Vaš liječnik bi mogao predložiti povećanje intervala između doza.

Kako i kada uzimati Tramal tablete?

Ovaj lijek se uzima na usta.

Tablete uvijek progutajte cijele s dovoljnom količinom tekućine.

Nemojte ih dijeliti ili žvakati.

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Možete ih uzeti uz jelo ili između obroka.

Kako dugo smijete uzimati Tramal tablete?

Ne smijete uzimati ovaj lijek više nego je potrebno. Ako je potrebno dugotrajno liječenje, Vaš će

liječnik provjeriti u redovitim kratkim razmacima (s odgovarajućim prekidima u liječenju) trebate li

nastaviti s uzimanjem Tramala i u kojoj dozi.

Ako mislite da je djelovanje Tramala prejako ili preslabo, obratite se Vašem liječniku.

Ako uzmete više Tramal tableta

Ako ste greškom uzeli još jednu dodatnu dozu Tramala, to neće izazvati negativan učinak. Slijedeću

dozu Tramala trebate uzeti kao što je propisano.

Ako ste Vi (ili netko drugi) uzeli vrlo visoke doze Tramala odmah se javite Vašem liječniku ili u

najbližu bolnicu.

Simptomi predoziranja uključuju: suženje zjenice, povraćanje, pad krvnog tlaka, ubrzano kucanje srca,

osjećaj da ćete se onesvijestiti, poremećaj svijesti sve do kome, epileptički napadaji i poteškoće u

disanju sve do prestanka disanja.

Ako ste zaboravili uzeti Tramal tablete

Ako ste zaboravili uzeti Tramal tablete s produljenim oslobađanjem, bol se može vratiti. Nemojte uzeti

dvostruku dozu kako biste nadoknadili zaboravljenu dozu, već nastavite s dozom koju ste prethodno

uzimali.

Ako prestanete uzimati Tramal tablete

Ako prerano prekinete uzimati Tramal, bol će se vjerojatno javiti.

Općenito se ne bi trebali javiti učinci nakon prestanka uzimanja Tramala. Međutim, rijetko se događa

da se kod bolesnika koji su uzimali Tramal kroz duže razdoblje može pojaviti naknadni učinak, ako

naglo prestanu s uzimanjem Tramala. Mogu se javiti nemir, tjeskoba, nervoza ili drhtanje. Mogu se

također javiti hiperaktivnost, problemi sa spavanjem ili želučane i probavne smetnje. Kod vrlo malog

broja ljudi mogu se javiti napadaji panike, priviđenja, neobični osjećaje, kao što je svrbež, trnci,

utrnulost ili zujanje u ušima (tinitus). Vrlo rijetko su zabilježeni smetenost, lažna uvjerenja (deluzije),

promjene u poimanju vlastite osobnosti i promjene u poimanju stvarnosti te strah da Vas netko

proganja (paranoja).

Ukoliko se jedna od navedenih nuspojava pojavi nakon prestanka uzimanja Tramala, obratite se

Vašem liječniku.

Ako imate bilo kakvih pitanja

u vezi s primjenom

ovog lijeka, obratite se Vašem liječniku ili

ljekarniku.

4.

Moguće nuspojave

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

Ukoliko se pojave simptomi alergijske reakcije obratite se ODMAH Vašem liječniku.

Simptomi alergijske reakcije mogu biti:

oticanje lica, jezika i/ili grla, i/ili poteškoće pri gutanju ili osip zajedno s otežanim

disanjem

Ostale nuspojave koje se mogu javiti uz ovaj lijek:

Vrlo često: mogu se javiti u više od 1 na 10 osoba

omaglica

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mučnina

Često: mogu se javiti u manje od 1 na 10 osoba

glavobolje, izrazita pospanost

iscrpljenost

zatvor, suha usta, povraćanje

prekomjerno znojenje

Manje često: mogu se javiti u manje od 1 na 100 osoba

Djelovanje na srce i krvnu cirkulaciju (osjećaj lupanja srca, ubrzani rad srca, osjećaj

nesvjestice prilikom ustajanja ili kolaps). Do ovih nuspojava može doći osobito kod bolesnika

pod fizičkim stresom.

nagon na povraćanje (dizanje želuca), želučani problemi (npr. osjećaj pritiska u želucu,

nadutost) i proljev

kožne reakcije (npr. svrbež, osip, koprivnjača)

Rijetko: mogu se javiti u manje od 1 na 1000 osoba

alergijske reakcije (npr. poteškoće disanja, hripavosti, natečena koža) i šok reakcije (iznenadni

prekid krvotoka) su se pojavile u vrlo rijetkim slučajevima

usporen rad srca

povišen krvni tlak

abnormalni osjećaji na koži (svrbež, trnci, izostanak osjeta), drhtanje, epileptički napadaji,

nevoljno stezanje mišića, poremećaji kordinacije, privremeni gubitak svijesti (sinkopa),

poremećaj govora

promjene apetita

priviđenja, zbunjenost, poremećaj spavanja, poremećaj svijesti, tjeskoba i noćne more

Psihičke nuspojave, koje mogu nastupiti nakon primjene Tramala, variraju po intenzitetu i

prirodi od bolesnika do bolesnika (što ovisi o osobnosti bolesnika i trajanju liječenja). One

obuhvaćaju promjene raspoloženja (obično veselo raspoloženje, povremeno uznemirenost),

promjene aktivnosti (obično smanjenu, povremeno povećanu aktivnost), te promjene u

osjetima i raspoznavanju (promjene u shvaćanju i prepoznavanju što može dovesti do grešaka

u sposobnosti prosuđivanja).

Može nastati ovisnost. Ako ste uzimali Tramal tablete s produljenim oslobađanjem u dužem

vremenskom razdoblju, može se pojaviti ovisnost, iako je opasnost vrlo mala. Nakon

prestanka uzimanja lijeka može se pojaviti reakcija ustezanja (pogledajte „Ako prestanete s

liječenjem Tramal tablete s produljenim oslobađanjem“).

zamagljen vid, sužavanje zjenice, prekomjerno širenje zjenica

jako usporeno disanje, otežano disanje (zaduha)

Zabilježeno je pogoršanje astme. Ako su prekoračene preporučene doze ili ako se u isto

vrijeme koriste drugi lijekovi koji utječu na funkciju disanja, može doći do usporenog disanja.

slabost mišića

poteškoće ili bol pri mokrenju, mokrenje manje mokraće nego što je normalno

Vrlo rijetko: mogu se javiti u manje od od 1 na 10000 osoba

povećanje vrijednosti jetrenih enzima

Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka

smanjenje razine šećera u krvi

Prijavljivanje nuspojava

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

svaku moguću nuspojavu koja nije navedena u ovoj uputi. Nuspojave možete prijaviti izravno putem

nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.

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Prijavljivanjem nuspojava možete pridonijeti u procjeni sigurnosti ovog lijeka.

5.

Kako čuvati Tramal tablete?

Ovaj lijek čuvajte izvan pogleda i dohvata djece.Ovaj lijek se ne smije upotrijebiti nakon isteka roka

valjanosti navedenog na kutiji. Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.

Ovaj lijek ne zahtjeva posebne uvjete čuvanja.

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

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

6.

Sadržaj pakiranja i druge informacije

Što Tramal tablete s produljenim oslobaĎanjem sadrže?

Djelatna tvar Tramal tablete s produljenim oslobađanjem je tramadolklorid.

Tramal 50 mg tablete s produljenim oslobađanjem:

Jedna tableta sadrži 50 mg tramadolklorida.

Tramal 100 mg tablete s produljenim oslobađanjem:

Jedna tableta sadrži 100 mg tramadolklorida.

Tramal 150 mg tablete s produljenim oslobađanjem:

Jedna tableta sadrži 150 mg tramadolklorida.

Tramal 200 mg tablete s produljenim oslobađanjem:

Jedna tableta sadrži 200 mg tramadolklorida.

Tramal tablete s produljenim oslobađanjem sadrže slijedeće pomoćne tvari:

Tramal 50 mg tablete s produljenim oslobađanjem :

Jezgra: mikrokristalična celuloza,hipromeloza, bezvodni koloidni silicijev dioksid, magnezijev stearat

Film-ovojnica: hipromeloza, laktoza hidrat, makrogol 6000, propilenglikol, talk, titanijev dioksid

(E171), žuti željezov oksid, (E172)

Tramal 100 mg tablete s produljenim oslobađanjem :

Jezgra: mikrokristalična celuloza, hipromeloza; bezvodni koloidni silicijev dioksid, ; magnezijev

stearat

Film-ovojnica: hipromeloza, laktoza hidrat, makrogol 6000, propilenglikol, talk, titanijev dioksid

(E171)

Tramal 150 mg tablete s produljenim oslobađanjem :

Jezgra: mikrokristalična celuloza,hipromeloza; bezvodni koloidni silicijev dioksid, magnezijev stearat

Film-ovojnica: hipromeloza, laktoza hidrat makrogol 6000 propilenglikol talk kinolin-žuta boja (E

104), crveni željezov oksid (E 172), titanijev dioksid (E 171)

Tramal 200 mg tablete s produljenim oslobađanjem:

Jezgra: mikrokristalična celuloza, hipromeloza; bezvodni koloidni silicijev dioksid, magnezijev stearat

Film-ovojnica: hipromeloza, laktoza hidrat, makrogol 6000, propilenglikol, talk, kinolin-žuta boja (E

104),crveni željezov oksid (E 172), smeđi željezov oksid (E 172), titanijev dioksid (E 171)

Kako Tramal tablete izgledaju i sadržaj pakiranja?

Tableta s produljenim oslobađanjem.

Okrugle, bikonveksne, filmom obložene tablete, s utisnutim logotipom proizvođača na jednoj strani.

- tableta od 50 mg: blijedo žute boje, s utisnutim T0 na drugoj strani, promjera 9,7 – 10,3 mm

- tableta od 100 mg: bijele boje, s utisnutim T1 na drugoj strani, promjera 9,7 – 10,3 mm

- tableta od 150 mg: svijetlonarančaste boje, s utisnutim T2 na drugoj strani, promjera 9,7 – 10,3 mm

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- tableta od 200 mg: smećkastonarančaste boje, s utisnutim T3 na drugoj strani, promjera 9,7 – 10,3

Tramal 50 mg tablete s produljenim oslobađanjem:

30 (3X10) tableta ili 50 (5X10) tableta u blister pakiranju, u kutiji

Tramal 100 mg, 150 mg, 200 mg tablete s produljenim oslobađanjem:

30 (3X10) tableta ili 50 (5X10) tableta ili 60 (6X10) tableta u blister pakiranju, u kutiji

Nositelj odobrenja za stavljanje lijeka u promet i proizvoĎač

Nositelj odobrenja:

Stada d.o.o., Hercegovačka 14, 10 000 Zagreb

ProizvoĎač:

STADA Arzneimittel AG,

Stadastr. 2-18, 61118 Bad Vilbel, Njemačka

Način i mjesto izdavanja lijeka

Lijek se izdaje na recept, u ljekarni

Ova uputa je zadnji puta revidirana u veljači 2017.

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15 - 02 - 2017

O D O B R E N O

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

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

9-11-2018

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

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

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

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

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

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

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

Health Canada

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

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

Health Canada

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

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

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

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

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

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

Health Canada

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

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

Health Canada

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

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

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

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

Health Canada

18-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

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

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Health Canada

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

17-9-2018

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

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

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

Europe - EMA - European Medicines Agency