Clozapin-Mepha 200 mg

Informazioni principali

  • Nome commerciale:
  • Clozapin-Mepha 200 mg Tabletten
  • Forma farmaceutica:
  • Tabletten
  • Composizione:
  • clozapinum 200 mg, excipiens pro compresso.
  • 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.


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Localizzazione

  • Disponibile in:
  • Clozapin-Mepha 200 mg Tabletten
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Neurolepticum

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66937
  • Data dell'autorizzazione:
  • 02-05-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Clozapin-Mepha® compresse

Mepha Pharma AG

Che cos'è Clozapin-Mepha e quando si usa?

Clozapin-Mepha è un medicamento per il trattamento dei disturbi psichici nei pazienti che non

rispondono ad altri farmaci utilizzati per lo stesso scopo o che reagiscono a quest'ultimi con gravi

effetti collaterali.

Si può usare Clozapin-Mepha anche in caso di psicosi che possono manifestarsi

contemporaneamente con il morbo di Parkinson, a condizione che tutte le altre terapie siano state

sfruttate.

Clozapin-Mepha è nello stesso tempo un medicamento per il trattamento di disturbi psichici nei

pazienti in cui a causa della malattia c'è un rischio di un comportamento auto-compromettente a

lungo termine.

Clozapin-Mepha deve essere assunto esclusivamente dietro prescrizione medica.

Quando non si può assumere Clozapin-Mepha?

Non assuma Clozapin-Mepha se il suo sangue presenta un numero insufficiente di globuli bianchi o

se in passato ha sofferto di un disturbo della generazione delle cellule ematiche. Clozapin-Mepha non

deve essere assunto nemmeno dai pazienti che soffrono di una grave affezione epatica, renale o

cardiaca.

Lo stesso discorso vale in presenza di epilessia non controllata, intossicazione da alcool o di altro

genere con o senza disturbi della funzione cerebrale. Clozapin-Mepha non deve essere assunto in

caso di profonda incoscienza o di collasso circolatorio. Il preparato non deve nemmeno essere

utilizzato se si manifesta un'ostruzione intestinale (ileo paralitico) o se, in occasione di una

precedente terapia, il paziente ha manifestato una reazione di ipersensibilità al farmaco.

Clozapin-Mepha non è indicato per i bambini e gli adolescenti di meno di 18 anni.

Quando è richiesta prudenza nella somministrazione di Clozapin-Mepha?

Se soffre di un'affezione epatica, renale o cardiaca di lieve entità - il medico deve essere informato! -

l'assunzione di Clozapin-Mepha è possibile, ma soltanto con molta prudenza (il farmaco non deve

assolutamente essere utilizzato in caso di affezioni epatiche, renali o cardiache gravi). Informi il suo

medico anche se soffre di un ingrossamento della prostata, convulsioni, glaucoma, allergie o altre

malattie.

Se soffre di diabete (aumento dello zucchero nel sangue), il suo medico dovrà controllare

periodicamente i suoi valori glicemici. Clozapin-Mepha può anche causare modificazioni dei grassi

nel sangue e un aumento del peso corporeo. Il suo medico potrà controllare il suo peso e i suoi valori

dei grassi nel sangue.

Questo medicamento può ridurre la capacità di reazione, la capacità di condurre veicoli e di utilizzare

attrezzi o macchine!

Clozapin-Mepha può provocare sonnolenza, in particolare all'inizio del trattamento. Perciò,

specialmente nelle prime settimane di trattamento occorre rinunciare alla guida e all'impiego di

macchinari.

Sono possibili interazioni tra Clozapin-Mepha e altri medicamenti, visto che il preparato potenzia

l'effetto dei calmanti, dei sonniferi e dei farmaci antiallergici. Altri medicamenti che possono

provocare interazioni con Clozapin-Mepha sono ad esempio gli antiepilettici, gli antidepressivi, gli

antipertensivi, i medicamenti per il trattamento dell'infezione HIV (AIDS), l'ulcera gastrica

(cimetidina), le micosi (antimicotici), così come antibiotici (eritromicina, rifampicina, fluvoxamina,

ciprofloxacina), i medicamenti costipanti, caffeina, pillole contraccettive e altri medicamenti per il

trattamento di disturbi psichici. Informi il suo medico se assume uno di questi o altri farmaci.

Spetterà a lui decidere quali preparati può assumere in concomitanza con Clozapin-Mepha.

Durante il trattamento con Clozapin-Mepha, eviti il consumo di bevande alcoliche; il preparato può

potenziare l'effetto dell'alcol.

Nei fumatori accaniti o in caso di altro tipo di consumo di nicotina, al momento di una improvvisa

interruzione del consumo di nicotina possono comparire nel sangue elevate concentrazioni della

sostanza attiva contenuta in Clozapin-Mepha; questa situazione potrebbe essere all'origine di un

incremento degli effetti collaterali.

L'assenza prolungata di movimento, dovuto per esempio a una lunga degenza a letto, può provocare

disturbi della circolazione sanguigna (formazione di coaguli). Si consiglia perciò di praticare un po'

di moto.

Clozapin-Mepha può favorire la comparsa di crampi muscolari. Se soffre di epilessia, una terapia con

questo farmaco potrebbe aumentare la probabilità di una crisi.

In caso di febbre alta, rigidità muscolare, respirazione accelerata, sudorazione eccessiva, diminuzione

della concentrazione, informi subito il suo medico. Potrebbe darsi che il suo corpo non reagisca in

modo corretto al medicamento.

Informi immediatamente il suo medico in presenza dei seguenti stati o sintomi:

·collasso circolatorio (sintomi: ad esempio improvvisa debolezza, vertigini, sudore freddo, disturbi

della vista, perdita di conoscenza), disturbi del ritmo cardiaco,

·miocardite o pericardite (sintomi: ad esempio palpitazioni, difficoltà di respirazione, agitazione,

spossatezza, dolore retrosternale, sintomi come l'influenza, febbre, respirazione accelerata, gonfiore

delle gambe),

·tromboembolia (occlusione di un vaso sanguigno ad opera di un trombo; sintomi: ad esempio dolore

e/o gonfiore in una gamba, improvvise difficoltà di respirazione, colorazione bluastra),

·ictus cerebrale, malattie cardiache o un disturbo della conduzione elettrica cardiaca, chiamato

allungamento dell'intervallo QT, nell'anamnesi familiare,

·infiammazioni del fegato (epatite, sintomi: ad esempio nausea, vomito, inappetenza) o ittero,

·costipazione (stitichezza).

Durante il trattamento con Clozapin-Mepha possono verificarsi i seguenti effetti collaterali:

·Durante l'assunzione di Clozapin-Mepha possono verificarsi episodi di capogiro o svenimento

dovuti a un calo della pressione arteriosa, in particolare all'inizio del trattamento.

·Spasmi muscolari, sonnolenza, svenimento, debolezza muscolare che possono causare cadute.

·Dolore toracico, che potrebbe essere sintomo di un infarto miocardico potenzialmente fatale.

·Dolore toracico riconducibile a un'infiammazione potenzialmente fatale del miocardio.

·Mal di pancia e costipazione, come possibili segni di una dilatazione anomala e potenzialmente

fatale dell'intestino crasso.

·Mal di pancia, che potrebbe essere un segno di necrosi (morte) potenzialmente fatale di una parte

dell'intestino causata da una circolazione insufficiente.

·Clozapin-Mepha può causare sonnolenza e prolungata permanenza a letto, con conseguente

aumento di peso, che in alcuni pazienti può portare alla formazione di trombi.

Durante il trattamento con clozapina si sono verificati casi di infarto miocardico con esito letale.

Poiché Clozapin-Mepha può causare sonnolenza, la combinazione tra una prolungata permanenza a

letto e l'aumento di peso può causare la formazione di trombi.

Perché occorre eseguire regolarmente dei controlli dell'emogramma?

Nel caso di un trattamento con Clozapin-Mepha, possono verificarsi gravi alterazioni

dell'emogramma (leucocitopenia = carenza di globuli bianchi). In caso di diagnosi precoce e di

interruzione immediata del farmaco (esclusivamente su indicazione medica), questi disturbi sono

reversibili. È perciò importante sottoporsi regolarmente a questi controlli:

durante le prime 18 settimane di trattamento, una volta alla settimana; in seguito almeno una volta al

mese.

Il medico continuerà ad effettuare i controlli dell'emogramma anche a trattamento ultimato.

Sintomi di questa alterazione dell'emogramma possono essere febbre, brividi, mal di gola,

infiammazione delle tonsille e difficoltà di cicatrizzazione. Ai primi sintomi di disturbi di questo

genere, deve consultare senza indugio il suo medico curante, che controllerà immediatamente

l'emogramma e se necessario prenderà ulteriori provvedimenti.

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

assume o applica esternamente altri medicamenti (anche acquistati di sua iniziativa!).

Si può assumere Clozapin-Mepha durante la gravidanza o l'allattamento?

Durante la gravidanza o l'allattamento, Clozapin-Mepha può essere assunto solo su prescrizione

medica. Nei neonati, le cui madri durante l'ultimo trimestre hanno assunto medicamenti antipsicotici,

dopo la nascita sussistono i seguenti rischi: arti rigidi, tremore, irrequietezza, rigidità muscolare,

debolezza muscolare, sonnolenza, difficoltà respiratoria, disturbi dell'alimentazione. In alcuni casi i

sintomi sono autolimitanti, in altri i neonati devono essere assistiti nel reparto di terapia intensiva e

rimanere ricoverati più al lungo.

La preghiamo di informare immediatamente il suo medico se è incinta o presume di esserlo, per

discutere di come procedere. Il trattamento non va in nessun caso interrotto di propria iniziativa. Una

sospensione improvvisa dell'assunzione di Clozapin-Mepha può determinare gravi conseguenze. Per

favore, informi immediatamente il suo ginecologo o l'ostetrica dell'assunzione durante la gravidanza,

in particolare se dopo la nascita nel suo bambino dovessero presentarsi i segni descritti.

Dato che la clozapina penetra nel latte materno, le madri che seguono un trattamento con Clozapin-

Mepha non devono allattare.

Come usare Clozapin-Mepha?

La posologia viene stabilita individualmente dal medico in base alla gravità della malattia. Per

ottenere un effetto ottimale del trattamento, segua scrupolosamente le indicazioni del medico.

L'uso e la sicurezza non sono stati studiati finora nei bambini ed adolescenti.

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.

Non interrompa il trattamento con Clozapin-Mepha senza prima aver consultato il suo medico,

poiché un'interruzione potrebbe determinare effetti indesiderati. Se fosse necessario interrompere

l'assunzione di Clozapin-Mepha, il suo medico ne ridurrà la dose lentamente nell'arco di 1 - 2

settimane, per evitare effetti indesiderati. Se si rendesse necessaria un'interruzione immediata,

potranno presentarsi i seguenti sintomi psicotici e d'astinenza: sudorazione accentuata, mal di testa,

nausea e diarrea, costrizione dei bronchi. Se avvertisse questi sintomi ne informi immediatamente il

suo medico, poiché dovranno essere immediatamente trattati.

Quali effetti collaterali può avere Clozapin-Mepha?

Con l'assunzione o l'applicazione di Clozapin-Mepha possono manifestarsi i seguenti effetti

collaterali:

L'effetto collaterale più frequente e più grave è una possibile leucocitopenia o carenza di globuli

bianchi (vedi «Quando è richiesta prudenza nella somministrazione di Clozapin-Mepha?/Perché

occorre eseguire regolarmente dei controlli dell'emogramma?»).

Effetti collaterali molto frequenti sono: sonnolenza, capogiro, battito cardiaco accelerato, stitichezza,

aumento o riduzione della secrezione salivare.

Effetti collaterali frequenti sono: aumento del peso, convulsioni, disturbi del linguaggio, mal di testa,

spasmi e scosse muscolari o rigidità muscolare, tremore, irrequietezza (cosiddetti sintomi

extrapiramidali), perdita di conoscenza, svenimento, visione annebbiata, caduta della pressione

arteriosa, pressione arteriosa elevata, alterazioni dell'ECG, nausea, vomito, secchezza della bocca,

aumento degli enzimi epatici, disfunzione vescicale, stanchezza, alterazione della sudorazione,

aumento della temperatura corporea.

Occasionalmente possono comparire crampi muscolari, disorientamento e oscillazioni della

pressione arteriosa.

In rari casi possono verificarsi aumento della glicemia (iperglicemia che in rari casi può portare al

coma), irrequietezza, agitazione, disorientamento, delirio, pensieri e comportamento compulsivi,

disturbi del ritmo cardiaco, infiammazioni o malattie del muscolo cardiaco o pericardite (con segni

come palpitazioni cardiache, affanno, irrequietezza, tendenza a stancarsi rapidamente, dolori dietro lo

sterno, disturbi simil-influenzali, febbre, respiro accelerato, gonfiore delle gambe), collasso

circolatorio, disturbi della deglutizione, difficoltà a respirare, infezioni delle vie respiratorie,

infiammazioni del fegato (epatite C), ittero e infiammazioni del pancreas, tromboembolia (ostruzione

acuta di un vaso sanguigno dovuta alla migrazione di un coagulo sanguigno, con segni come dolore

in una gamba e/o gonfiore monolaterale di una gamba, improvvisa difficoltà respiratoria, cianosi).

Effetti collaterali molto rari sono occlusione intestinale (ileo), reazioni cutanee, valori elevati della

colesterolemia e dei lipidi nel sangue, disfunzioni renali, disfunzioni sessuali.

Frequenza sconosciuta

Disturbi epatici come steatosi epatica («fegato grasso»), apoptosi degli epatociti e danni epatici.

Disturbi del fegato che portano a sostituire i normali tessuti epatici con tessuto cicatrizzante e che

portano quindi alla perdita della funzione epatica fino a situazioni che possono mettere in pericolo la

vita. Queste situazioni possono essere un blocco epatico, un danneggiamento del fegato e un

trapianto di fegato.

Sensazione sporadica di «battiti», «colpi» o «palpitazioni» nel petto (tachicardia).

Cadute dovute a spasmi muscolari, sonnolenza, svenimento, debolezza muscolare causati da

Clozapin-Mepha.

Dolore toracico come possibile sintomo di un infarto miocardico potenzialmente fatale.

Dolore toracico come possibile segno di un'infiammazione potenzialmente fatale del miocardio.

Dolore toracico, singhiozzo, respirazione accelerata (segno di un accumulo di liquidi tra i tessuti che

rivestono i polmoni e la cavità toracica).

Battito cardiaco accelerato o irregolare (fibrillazione atriale). Occasionalmente possono manifestarsi

anche cardiopalmo, perdita di coscienza, respiro affannoso o dolore toracico.

Mal di pancia e costipazione, come possibili segni di una dilatazione anomala e potenzialmente fatale

dell'intestino crasso.

Mal di pancia, che potrebbe essere un segno di necrosi (morte) potenzialmente fatale di una parte

dell'intestino causata da una circolazione insufficiente.

Spasmi muscolari, febbre, urine di colore marrone-rossastro come possibili segni di una

degenerazione muscolare (rabdomiolisi).

Dolore toracico e addominale di grado variabile, come possibile segno di un'infiammazione di

membrane in più cavità dell'organismo contemporaneamente, ad esempio nel torace, nell'addome e

nelle articolazioni.

Infezione accertata o fortemente sospetta, accompagnata da febbre o temperatura corporea bassa,

respiro insolitamente rapido, battito cardiaco accelerato, alterazioni della funzione sensoriale e della

consapevolezza, calo della pressione sanguigna (sepsi).

Apnee (interruzioni della respirazione) o fasi di respirazione superficiale durante il sonno.

Reazione allergica (gonfiore in particolare del viso, della bocca e della lingua, eventualmente

accompagnato da prurito o da dolori).

Incontinenza notturna.

Eruzione cutanea, macchie violacee o rosse, febbre o prurito causati da un'infiammazione dei vasi

sanguigni.

Infiammazione del colon che causa diarrea, dolori addominali, febbre.

Modificazione del colorito cutaneo.

Eruzione cutanea «a farfalla» del viso, dolori articolari, dolori muscolari, febbre e affaticamento

(lupus eritematoso).

Aumento improvviso e incontrollabile della pressione arteriosa (pseudofeocromocitoma).

Ipotensione.

Curvatura del corpo da un lato, incontrollata (pleurototono).

Aumento di peso eccessivo (il peso corporeo deve essere almeno del 20% più alto di quanto

dovrebbe essere).

Forte impulso di muovere le gambe (sindrome delle gambe senza riposo o Restless Legs Syndrom)

associato ad una sensazione di malessere alle gambe.

Se lei è un uomo: disturbo dell'eiaculazione in cui lo sperma entra nella vescica anziché essere

eiaculato attraverso il pene (orgasmo secco o eiaculazione retrograda).

In caso di erezione prolungata e dolorosa senza stimolazione sessuale (priapismo) occorre consultare

immediatamente un urologo.

Per maggiori informazioni sui sintomi degli effetti collaterali gravi, si rimanda al paragrafo «Quando

la somministrazione di Clozapin-Mepha richiede prudenza?».

Se dovesse manifestarsi uno degli effetti collaterali descritti o se osserva effetti collaterali qui non

descritti dovrebbe informare il suo medico o farmacista.

Di che altro occorre tener conto?

Conservare nella confezione originale e a temperatura inferiore a 30 °C.

Tenere fuori dalla portata dei bambini.

Il medicamento non dev'essere utilizzato oltre la data indicata con «EXP» sulla confezione.

Il medico o il farmacista, che sono in possesso di un'informazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene Clozapin-Mepha?

La sostanza attiva di Clozapin-Mepha è la clozapina.

1 compressa contiene 25 mg, 100 mg risp. 200 mg di clozapina, nonché eccipienti (inoltre lattosio).

Numero dell’omologazione

66937 (Swissmedic).

Dove è ottenibile Clozapin-Mepha? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

Clozapin-Mepha 25 mg: confezioni da 50 compresse (divisibili).

Clozapin-Mepha 100 mg: confezioni da 50 compresse (divisibili).

Clozapin-Mepha 200 mg: confezioni da 50 compresse.

Titolare dell’omologazione

Mepha Pharma AG, Basel.

Questo foglietto illustrativo è stato controllato l'ultima volta nel mese di maggio 2018 dall'autorità

competente in materia di medicamenti (Swissmedic).

Numero interno della versione: 2.1

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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

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

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