Pregabalin Axapharm 200 mg

Informazioni principali

  • Nome commerciale:
  • Pregabalin Axapharm 200 mg Kapseln
  • Forma farmaceutica:
  • Kapseln
  • Composizione:
  • pregabalinum 200 mg, excipiens pro il capsula.
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco biologico

Documenti

  • per i professionisti:
  • Il foglio illustrativo per questo prodotto non è al momento disponibile, é possibile inviare una richiesta al nostro Servizio Clienti ed essere avvisati nel momento in cui è disponibile sulla nostra piattaforma.


    Richiedi il foglio illustrativo per i professionisti.

Localizzazione

  • Disponibile in:
  • Pregabalin Axapharm 200 mg Kapseln
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Neuropathische Schmerzen, Epilessia, generalisierte Angststörungen

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66392
  • Data dell'autorizzazione:
  • 15-02-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Informazione destinata ai pazienti

Legga attentamente il foglietto illustrativo prima di far uso del medicamento.

Questo medicamento le è stato prescritto personalmente e quindi non deve essere consegnato ad altre

persone, anche se i sintomi sono gli stessi. Il medicamento potrebbe nuocere alla loro salute.

Conservi il foglietto illustrativo per poterlo rileggere all’occorrenza.

Pregabalina Axapharm, capsule

Che cos’è Pregabalina Axapharm e quando si usa?

Pregabalina Axapharm appartiene alla classe dei farmaci chiamati ligandi di alfa-2-delta. Questi

medicamenti vengono impiegati nella terapia dell’epilessia e dei dolori neuropatici nell’adulto.

Inoltre, Pregabalina Axapharm viene impiegato negli adulti nel trattamento dei disturbi d’ansia

generalizzata.

Dolori neuropatici periferici e centrali

Pregabalina Axapharm è utilizzato nell’adulto per il trattamento di dolori persistenti che insorgono a

causa di lesioni dei nervi. Il dolore è descrivibile come scottante, bruciante, pulsante, a fitte o

lancinante. Può insorgere anche intorpidimento, prurito o formicolio. Il dolore neuropatico può

essere accompagnato da cambiamenti dello stato d’animo, disturbi del sonno e stanchezza.

Epilessia

Pregabalina Axapharm è utilizzato per il trattamento di una forma specifica di epilessia nell’adulto

(crisi parziali con o senza generalizzazione secondaria). Il suo medico le prescriverà Pregabalina

Axapharm se la sua terapia attuale non fosse sufficiente per tenere la malattia completamente sotto

controllo. Pregabalina Axapharm va preso in aggiunta alla sua terapia medicamentosa attuale.

Disturbi d’ansia generalizzati

Pregabalina Axapharm viene utilizzato nell’adulto per la terapia dei disturbi d’ansia generalizzati. I

sintomi dei disturbi d’ansia generalizzati sono stati d’ansia e di preoccupazione prolungati e

difficilmente curabili. I disturbi d’ansia generalizzati possono provocare anche inquietudine, stati di

tensione, tendenza alla spossatezza, disturbi della concentrazione e mancanza di pensieri, irritabilità,

contratture muscolari o disturbi del sonno.

Pregabalina Axapharm deve essere assunto solo su prescrizione medica.

Finora non è stato studiato l’impiego di Pregabalina Axapharm nei bambini e negli adolescenti sotto i

18 anni, perciò se ne sconsiglia l’uso in questa fascia d’età.

Quando non si può assumere Pregabalina Axapharm?

Non deve assumere Pregabalina Axapharm se lei è allergica/o al principio attivo pregabalina, a un

altro farmaco della stessa classe (per es. il Neurontin) o a una delle sostanze ausiliarie.

Quando è richiesta prudenza nella somministrazione di Pregabalina Axapharm?

Pregabalina Axapharm può provocare senso di stordimento, sonnolenza o stanchezza. Sono state

anche descritte perdita di coscienza, confusione e alterazione dello stato mentale. Di conseguenza,

questo medicamento può ridurre la capacità di reazione, la capacità di condurre un veicolo e la

capacità di utilizzare attrezzi o macchine. Inoltre, può accrescere la possibilità di infortuni (rischio di

cadute). Si raccomanda quindi al paziente di fare particolare attenzione finché non si sarà abituato a

tutti gli effetti che il farmaco potrebbe avere.

Informi il medico prima di assumere questo medicamento se soffre o ha sofferto di una patologia

cardiaca (indebolimento della funzione del cuore, efficienza cardiaca insufficiente).

Alcuni pazienti che hanno assunto Pregabalina Axapharm hanno riferito disturbi che potrebbero far

supporre una reazione allergica. Questi disturbi comprendevano, per esempio, tumefazioni a carico

del volto, delle labbra, della lingua o delle vie respiratorie o anche un vasto arrossamento cutaneo.

Nel caso in cui compaiano questi disturbi, dovrà recarsi immediatamente presso il suo medico.

Durante l’assunzione di Pregabalina Axapharm possono manifestarsi visione indistinta o altri disturbi

della vista. Informi immediatamente il medico qualora dovesse notare qualsiasi alterazione della sua

capacità visiva.

In caso di limitata funzione renale, il suo medico regolerà di conseguenza la dose di Pregabalina

Axapharm. In caso di funzione renale gravemente limitata, lei non deve assumere Pregabalina

Axapharm.

Nei pazienti con disturbi della funzione epatica, Pregabalina Axapharm deve essere assunto con

cautela.

In alcuni pazienti, è stata segnalata insufficienza renale in seguito all’assunzione di Pregabalina

Axapharm. Se durante l’assunzione di Pregabalina Axapharm nota una riduzione della quantità di

urina, deve contattare il suo medico perché ciò può essere eventualmente corretto tramite una

riduzione della dose del medicamento.

Un limitato numero di pazienti trattati con antiepilettici come Pregabalina Axapharm hanno

presentato pensieri di ferire se stessi o di togliersi la vita. Se in un momento qualsiasi si dovessero

presentare pensieri di questo tipo, si metta immediatamente in contatto con il suo medico.

Se è o è stato affetto da dipendenza da alcool o da stupefacenti, è opportuno che lei consulti il suo

medico prima di assumere questo medicamento. Informi il suo medico se ritiene di avere bisogno di

una quantità di medicamento maggiore di quanto le sia stato prescritto.

In alcuni pazienti con diabete che in seguito al trattamento con pregabalina aumentano di peso, può

essere necessario regolare il medicamento antidiabetico.

In pazienti con lesioni del midollo spinale si possono verificare con maggiore frequenza effetti

indesiderati come, per esempio, la sonnolenza, visto che tali pazienti assumono probabilmente anche

medicamenti per il trattamento del dolore o dei crampi (spasticità) che hanno effetti collaterali simili

a quelli di Pregabalina Axapharm. Ciò può aumentare l’intensità di tali effetti collaterali.

Pregabalina Axapharm e alcuni altri farmaci possono interagire, ossia influenzarsi a vicenda. In

particolare, l’oxicodone (un analgesico) e il lorazepam (un ansiolitico) possono peggiorare l’entità

del torpore e della sonnolenza e ridurre ulteriormente la capacità di concentrazione. L’effetto

costipante di altri medicamenti, per es. degli oppioidi (antidolorifici), può essere accentuato

dall’impiego concomitante con Pregabalina Axapharm.

Pregabalina Axapharm può essere preso insieme alla pillola anticoncezionale.

Durante la terapia con Pregabalina Axapharm è possibile che l’effetto dell’alcool venga potenziato.

Dopo interruzione di una terapia a breve o a lungo termine con Pregabalina Axapharm sono stati

osservati, in alcuni pazienti, dei sintomi da astinenza (quali per es. disturbi del sonno, mal di testa,

nausea, diarrea, sintomi influenzali, nervosismo, depressione, sensazione di ansia, dolori,

sudorazione e stordimento), che possono essere anche interpretati come sintomi dovuti a dipendenza

fisica.

Informi il medico o il farmacista nel caso in cui soffre di altre malattie, soffre di allergie o assume o

applica esternamente altri medicamenti (anche se acquistati di sua iniziativa)!

Si può somministrare Pregabalina Axapharm durante la gravidanza o l’allattamento?

Pregabalina Axapharm non deve essere utilizzato durante la gravidanza, salvo diversa prescrizione

del medico. Le donne in età fertile devono adottare un metodo contraccettivo efficace. Informi

immediatamente il medico se durante il trattamento con Pregabalina Axapharm rimane incinta.

Il principio attivo di Pregabalina Axapharm, la pregabalina, passa nel latte materno. È quindi

necessario interrompere o l’allattamento al seno o il trattamento con Pregabalina Axapharm. Il suo

medico le illustrerà la soluzione più adatta al suo caso tenuti conto i benefici della terapia.

Come usare Pregabalina Axapharm?

Prenda Pregabalina Axapharm seguendo sempre attentamente le indicazioni del medico, che stabilirà

la dose adeguata al suo caso. La dose adatta a lei e alla sua malattia in genere è compresa tra 150 mg

e 600 mg al giorno.

Pregabalina Axapharm deve essere assunto due o tre volte al giorno. Per esempio, per una dose

giornaliera di 150 mg prenda una capsula da 75 mg la mattina e una la sera, oppure una capsula da 50

mg la mattina, una a mezzogiorno e una la sera. Il medico, se lo riterrà opportuno, aumenterà

progressivamente la dose, regolandosi sulla sua reazione al medicamento.

Deglutisca le capsule senza masticarle con abbastanza d’acqua. Le capsule di Pregabalina Axapharm

possono essere prese sia durante che tra i pasti.

Prenda Pregabalina Axapharm regolarmente finché il medico non deciderà di cessare la terapia.

Dopo la conclusione del trattamento con pregabalina possono comparire alcuni effetti collaterali,

come manifestazioni di astinenza. Questi comprendono: disturbi del sonno, mal di testa, nausea,

diarrea, sintomi similinfluenzali, nervosismo, depressioni, sensazione di ansia, dolori, sudorazione e

senso di stordimento.

Finora non sono state sperimentate l’efficacia e la sicurezza di pregabalina nei bambini e negli

adolescenti sotto i 18 anni, perciò se ne sconsiglia l’uso in questa fascia d’età.

Non modifichi di propria iniziativa la posologia prescritta. Se ritiene che l’azione del medicamento

sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Se ha assunto una dose eccessiva di Pregabalina Axapharm

Informi immediatamente il medico o si rechi al pronto soccorso più vicino: porti con sé la confezione

con le capsule di Pregabalina Axapharm.

Se ha dimenticato di prendere il medicamento

È importante assumere Pregabalina Axapharm regolarmente, ogni giorno circa alla stessa ora. Se una

volta si dimentica di prenderlo, assuma la capsula appena se ne accorge, a meno che non sia già l’ora

della dose successiva. In questo caso prenda solo la dose successiva, come d’abitudine. Non assuma

mai due dosi contemporaneamente per recuperarne una dimenticata.

Quali effetti collaterali può avere Pregabalina Axapharm?

In seguito all’assunzione di Pregabalina Axapharm possono manifestarsi i seguenti effetti collaterali:

Molto frequenti (possono presentarsi in più di 1 paziente su 10): senso di stordimento, sonnolenza.

Frequenti (possono presentarsi in più di 1 paziente su 100): infezioni delle alte vie respiratorie,

aumento dell’appetito, euforia, confusione, irritabilità, depressione, disorientamento, insonnia,

diminuzione della libido, disturbi nell’esecuzione dei movimenti, amnesia, difficoltà a mantenere

l’attenzione, disturbi della coordinazione, dell’equilibrio, della memoria e del linguaggio, tremori,

disturbi sensitivi quali formicolio, bruciore o intorpidimento (parestesie), ridotta sensibilità agli

stimoli tattili, apatia, vista annebbiata, visione sdoppiata, vomito, stipsi, flatulenza, secchezza della

bocca, crampi muscolari, dolori alle articolazioni, agli arti e alla schiena, spasmi nella regione del

collo, ritenzione di liquidi nei tessuti (edema), andatura anomala, cadute, sensazione di ebbrezza,

intorpidimento, esaurimento, aumento di peso.

Occasionali (possono presentarsi in più di 1 paziente su 1000): riduzione del numero di globuli

bianchi nel sangue, mancanza d’appetito, glicemia troppo alta o troppo bassa, allucinazioni,

irrequietezza, depressione, sbalzi d’umore, cambiamenti della personalità, sogni anormali, problemi

nel trovare le parole, aumento della libido, incapacità di raggiungere l’orgasmo, svenimenti

improvvisi, scosse muscolari, iperattività, disturbi del movimento in una regione del corpo o in una

parte del corpo, capogiri nel cambiare posizione, tremori da movimento, movimenti oculari insoliti,

disturbi del pensiero, disturbi del linguaggio, riflessi attenuati, aumentata sensibilità agli stimoli

tattili, sensazione di bruciore, visione a tunnel, visione offuscata, occhi gonfi, secchi, doloranti o

lacrimanti, riduzione del campo visivo, ridotta acuità visiva, affaticamento della vista, disturbi della

percezione visiva, irritazione oculare, aumento o diminuzione della frequenza del polso, disturbi del

ritmo cardiaco, pressione arteriosa elevata o diminuita, arrossamento del viso o della cute, vampate

di calore, problemi respiratori, sangue dal naso, tosse, naso chiuso o raffreddore, russamento, riflusso

d’acidità, aumento della salivazione, riduzione della sensibilità al tocco e al dolore nella zona della

bocca, eruzione cutanea, orticaria, sudorazione, gonfiore delle articolazioni, dolori ai muscoli, spasmi

muscolari, dolori al collo, rigidità della muscolatura, perdita d’urina involontaria (incontinenza),

dolori e difficoltà nella minzione, disturbi dell’erezione, disturbi della funzione sessuale,

eiaculazione ritardata, mestruazioni dolorose, sensazione di restringimento al petto, dolori, febbre,

sete, brividi, sensazione di debolezza, perdita di peso.

Rari (possono presentarsi in meno di 1 paziente su 1000): attacchi di panico, disinibizione, apatia,

irrigidimento (totale perdita di attività durante lo stato cosciente), allucinazioni olfattive, perdita del

gusto, riduzione della capacità di movimento, disturbi della scrittura, oscillopsia (un disturbo della

vista caratterizzato dalla percezione di movimento degli oggetti circostanti), modificazione della

visione tridimensionale, disfunzione pupillare, strabismo, sensibilità alla luce, aumentata sensibilità

al rumore, mani e piedi freddi, sensazione di ristrettezza nella gola, naso secco, ascite, pancreatite,

disturbi di deglutizione, sudorazione fredda, cedimento muscolare, disfunzione renale, diuresi ridotta,

dolori al seno, mancata mestruazione, secrezione dal capezzolo, ingrossamento delle mammelle.

Dopo l’introduzione sul mercato sono stati osservati inoltre i seguenti effetti collaterali: mal di testa,

nausea, diarrea, reazioni allergiche, (comprese tumefazioni a carico del volto o della lingua o disturbi

respiratori o anche una grave reazione cutanea caratterizzata da eruzione, formazione di bolle,

esfoliazione della cute e dolore), edema polmonare (accumulo di liquido nei polmoni), perdita di

coscienza, alterazione dello stato psichico, ritenzione urinaria, insufficienza cardiaca, prurito,

infiammazione degli occhi, malessere, ingrossamento della ghiandola mammaria.

Nel caso in cui notasse la comparsa di tumefazioni del volto o della lingua o un arrossamento della

pelle che iniziasse a formare bolle o a esfoliarsi, ne informi immediatamente il suo medico.

Se uno di questi effetti collaterali le crea disturbi o non si attenua nel corso del trattamento, informi il

suo medico.

Se osserva effetti collaterali qui non descritti, dovrebbe informare il suo medico o il suo farmacista.

Di che altro occorre tener conto?

Il medicamento non dev’essere utilizzato oltre la data indicata con «EXP.» sul contenitore.

Conservare Pregabalina Axapharm a temperatura ambiente (15-25°C) nella confezione originale e

fuori dalla portata dei bambini.

Il medico e il farmacista, che sono in possesso di un’informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Pregabalina Axapharm?

1 capsula da 25 mg contiene 25 mg di pregabalina. Le capsule da 25 mg sono bianche e hanno un

timbro nero «138»/«J».

1 capsula da 50 mg contiene 50 mg di pregabalina. Le capsule da 50 mg sono bianche e hanno un

timbro nero «139»/«J».

1 capsula da 75 mg contiene 75 mg di pregabalina. Le capsule da 75 mg sono bianche e arancioni e

hanno un timbro nero «140»/«J».

1 capsula da 100 mg contiene 100 mg di pregabalina. Le capsule da 100 mg sono arancioni e hanno

un timbro nero «141»/«J».

1 capsula da 150 mg contiene 150 mg di pregabalina. Le capsule da 150 mg sono bianche e hanno un

timbro nero «142»/«J».

1 capsula da 200 mg contiene 200 mg di pregabalina. Le capsule da 200 mg sono arancione chiaro e

hanno un timbro nero «143»/«J».

1 capsula da 300 mg contiene 300 mg di pregabalina. Le capsule da 300 mg sono bianche e

arancione e hanno un timbro nero «145»/«J».

Le capsule contengono sostanze ausiliarie.

Numero dell’omologazione

66392 (Swissmedic).

Dove è ottenibile Pregabalina Axapharm? Quali confezioni sono disponibili?

In farmacia, solo dietro presentazione della prescrizione medica.

Pregabalina Axapharm 25 mg: 14 e 56 capsule.

Pregabalina Axapharm 50 mg: 14 e 84 capsule.

Pregabalina Axapharm 75 mg: 14 e 56 capsule.

Pregabalina Axapharm 100 mg: 84 capsule.

Pregabalina Axapharm 150 mg: 56 e 168 capsule.

Pregabalina Axapharm 200 mg: 84 capsule.

Pregabalina Axapharm 300 mg: 56 e 168 capsule.

Titolare dell’omologazione

Axapharm SA, 6340 Baar.

Questo foglietto illustrativo è stato controllato l’ultima volta nell’ottobre 2014 dall’autorità

competente in materia di medicamenti (Swissmedic).

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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

19-9-2018

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Mylan S.A.S.)

Pregabalin Mylan Pharma (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 6097 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3962/T/08

Europe -DG Health and Food Safety

19-9-2018

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Mylan S.A.S.)

Pregabalin Mylan (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 5971 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4078/T/10

Europe -DG Health and Food Safety

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