Amoxicillin Spirig HC 200 mg/4 ml

Informazioni principali

  • Nome commerciale:
  • Amoxicillin Spirig HC 200 mg/4 ml Pulver zur Herstellung einer Sospensione zum Einnehmen
  • Forma farmaceutica:
  • Pulver zur Herstellung einer Sospensione zum Einnehmen
  • Composizione:
  • amoxicillinum anhydricum 200 mg ut amoxicillinum trihydricum, arom.: vanillinum et alia, saccharinum natricum, excipiens annuncio pulverem corrisp. suspensio reconstituta 4 ml.
  • 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:
  • Amoxicillin Spirig HC 200 mg/4 ml Pulver zur Herstellung einer Sospensione zum Einnehmen
    Svizzera
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Gruppo terapeutico:
  • Synthetika
  • Area terapeutica:
  • Infektionskrankheiten

Altre informazioni

Status

  • Fonte:
  • Swissmedic - Swiss Agency for Therapeutic Products
  • Numero dell'autorizzazione:
  • 66700
  • Data dell'autorizzazione:
  • 02-08-2018
  • Ultimo aggiornamento:
  • 19-10-2018

Foglio illustrativo

Patienteninformation

Amoxicillina Spirig HC® 200 mg/4 ml, polvere per la preparazione di una sospensione

Spirig HealthCare AG

Che cos'è l'Amoxicillina Spirig HC 200 mg/4 ml e quando si usa?

L'Amoxicillina Spirig HC 200 mg/4 ml è un antibiotico del gruppo delle penicilline. Il suo principio

attivo, l'amoxicillina, distrugge numerosi batteri responsabili di infezioni frequenti.

L'Amoxicillina Spirig HC 200 mg/4 ml si usa esclusivamente su prescrizione medica per il

trattamento delle seguenti infezioni batteriche:

infezioni del naso, dei seni paranasali frontali e mascellari, della gola, delle tonsille e delle orecchie;

infezioni delle vie respiratorie (bronchi e polmoni);

infezioni dei reni, della vescica e delle vie urinarie;

infezioni dello stomaco e dell'intestino; ulcera gastrica o duodenale con comprovata infezione da

Helicobacter pylori, in associazione a un inibitore della pompa protonica e ad un altro antibiotico;

infezioni degli organi genitali (gonorrea, secrezione di muco);

infezioni ginecologiche;

infezioni della pelle e dei tessuti molli (foruncoli, ascessi ecc.).

Malattia di Lyme (a causa del morso di una zecca si forma un arrossamento che si estende in modo

centrifugo ed è associato a disturbi fisici generali come mal di testa).

L'Amoxicillina Spirig HC 200 mg/4 ml è pure indicato per prevenire l'endocardite batterica in caso

di interventi odontoiatrici (per esempio estrazione, asportazione del tartaro, otturazione), di

endoscopie (esami delle pareti interne di organi cavi) e di altre operazioni sovente associate a rischio

d'infezione.

La dose singola di 3 g di Amoxicillina Spirig HC 200 mg/4 ml è consigliata

·per il trattamento della gonorrea e di infezioni delle cosiddette vie urinarie inferiori (uretrite =

infiammazione dell'uretra, cistite = infiammazione delle vescica);

·per la prevenzione dell'endocardite batterica in caso di interventi odontoiatrici o di altre operazioni

sovente associate a rischio d'infezione.

Di che cosa occorre inoltre tener conto durante il trattamento?

Questo medicamento le è stato prescritto dal suo medico per curare la malattia di cui lei soffre

attualmente.

L'antibiotico contenuto nell'Amoxicillina Spirig HC 200 mg/4 ml non è efficace contro tutti i

microorganismi che causano malattie infettive. L'uso di un antibiotico scelto in modo inappropriato

oppure a dosi sbagliate può provocare delle complicazioni. Perciò non lo adoperi mai di sua

iniziativa per curare altre malattie o altre persone. Anche se ulteriormente dovessero insorgere delle

nuove infezioni non può usare l'Amoxicillina Spirig HC 200 mg/4 ml senza aver di nuovo consultato

il medico.

Spesso i sintomi della malattia scompaiono prima che l'infezione sia completamente guarita. Perciò

non deve cessare prematuramente la terapia, anche se si sente meglio. Secondo le circostanze la

terapia può durare fino a due settimane o più, conformemente alle istruzioni del suo medico.

Quando non si può assumere l'Amoxicillina Spirig HC 200 mg/4 ml?

Non deve assumere l'Amoxicillina Spirig HC 200 mg/4 ml se in passato ha avuto una reazione

allergica a penicilline o a cefalosporine. Un'allergia o un'ipersensibilità si manifesta con sintomi quali

macchie rosse sulla pelle, febbre o dolori alla lingua.

L'Amoxicillina Spirig HC 200 mg/4 ml non si può usare in caso di ipersensibilità nota o presunta a

uno degli altri costituenti del medicamento.

Non può assumere l'Amoxicillina Spirig HC 200 mg/4 ml se soffre di febbre ghiandolare di Pfeiffer

o di leucemia linfatica.

Quando è richiesta prudenza nella somministrazione dell'Amoxicillina Spirig HC 200 mg/4 ml?

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

capacità di utilizzare attrezzi o macchine!

Quando si prende l'Amoxicillina Spirig HC 200 mg/4 ml sono possibili dei disturbi digestivi. In caso

di disturbi gastrointestinali gravi persistenti con vomito e diarrea si deve cessare di assumere il

medicamento e avvertire subito il medico. Si deve pure avvertire il medico o il farmacista se si

manifestano eruzioni sulla pelle o prurito.

Se si manifesta diarrea non si possono assumere medicamenti che inibiscono la peristalsi intestinale

(movimenti ritmici dell'intestino che ne fanno progredire il contenuto).

Se soffre di allergie quali asma, raffreddore da fieno od orticaria si impone particolare prudenza

nell'uso dell'Amoxicillina Spirig HC 200 mg/4 ml a causa di una possibile ipersensibilità.

Sono stati riportati casi isolati di reazioni allergiche particolarmente gravi dopo l'assunzione di

Amoxicillina Spirig HC 200 mg/4 ml, come la reazione da farmaco con eosinofilia e sintomi

sistemici (DRESS, una sindrome potenzialmente letale). Possibili segni di una tale reazione allergica

sono:

·sintomi simil-influenzali con eruzione cutanea e febbre,

·eruzione cutanea

·gonfiori del viso o altra parte del corpo

Ai primi segni di una simile reazione allergica, deve sospendere l'assunzione di Amoxicillina Spirig

HC 200 mg/4 ml e prendere immediatamente contatto con il medico!

Inoltre, informi il suo medico se nel passato ha sviluppato tali sintomi (sindrome di DRESS) con altri

farmaci, perché l'amoxicillina può provocare di nuovo una sindrome di DRESS.

I pazienti che contemporaneamente devono prendere dei preparati contenenti allopurinolo (per

esempio Zyloric®) hanno una maggior tendenza alle eruzioni sulla pelle.

Se prende dei preparati contenenti digossina deve informarne il medico o il farmacista. Lo stesso

dicasi se assume degli anticoagulanti.

ln caso di funzionalità insufficiente dei reni o del fegato l'Amoxicillina Spirig HC 200 mg/4 ml va

usato solo con prudenza.

Se prende un contraccettivo orale («pillola») tenga presente che durante la terapia coll'Amoxicillina

Spirig HC 200 mg/4 ml la sua efficacia può essere diminuita. Perciò, durante la terapia

coll'Amoxicillina Spirig HC 200 mg/4 ml si devono adottare ulteriori misure anticoncezionali.

Informi il suo medico o il suo farmacista nel caso in cui:

·soffra di altre malattie,

·soffra di allergie o

·assuma o applichi esternamente altri medicamenti (anche se acquistati di sua iniziativa).

Si può assumere l'Amoxicillina Spirig HC 200 mg/4 ml durante la gravidanza o l'allattamento?

Gravidanza

Durante la gravidanza l'assunzione di medicamenti di qualsiasi genere va decisa con la massima

prudenza e soltanto dopo aver consultato il medico o il farmacista.

Allattamento

Dato che l'Amoxicillina Spirig HC 200 mg/4 ml passa nel latte materno, nei lattanti si deve tener

conto della possibilità di una reazione di ipersensibilità (con sintomi quali arrossamento della pelle e

febbre) o di diarrea. Perciò durante l'allattamento non si deve assumere l'Amoxicillina Spirig HC 200

mg/4 ml oppure bisogna smettere di allattare.

Se è incinta, prevede una gravidanza o desidera allattare informi in ogni caso il medico o il

farmacista: sono le uniche persone che possono decidere se in queste situazioni lei può prendere

l'Amoxicillina Spirig HC 200 mg/4 ml.

Come usare l'Amoxicillina Spirig HC 200 mg/4 ml?

L'Amoxicillina Spirig HC 200 mg/4 ml si può prendere senza perdita di efficacia durante o dopo i

pasti; inoltre così si riduce il rischio di effetti collaterali.

La posologia dipende dall'età, dal peso e dalla funzionalità renale del paziente, come pure dalla

gravità dell'infezione e dalla sensibilità dell'agente patogeno.

Salvo diversa prescrizione del medico, la posologia è la seguente:

Adulti e bambini di peso superiore a 40 kg

Per il trattamento di adulti e bambini di peso superiore a 40 kg si usano le compresse di amoxicillina.

Infezioni leggere o di media gravità: 375-750 mg di Amoxicillina Spirig HC 3-4 volte al giorno.

Infezioni delle vie urinarie: 3 g da prendersi in un'unica dose.

Malattia di Lyme: 750 mg 3-4 volte al giorno per 12 giorni in presenza di una macchia circolare di

color rosso chiaro che cresce lentamente con zona più pallida al centro (= eritema migrante).

Eradicazione dell'Helicobacter pylori:

Adulti: 750 mg 2 volte al giorno o 1000 mg 2 volte al giorno in associazione a un inibitore della

pompa protonica e ad un altro antibiotico, per 10-14 giorni.

Bambini fino a 40 kg compresi

Per calcolare la dose adeguata il medico si basa sul peso del bambino e sulla gravità dell'infezione.

Per il trattamento delle infezioni nei bambini è adatta la sospensione Amoxicillina Spirig HC 200

mg/4 ml.

Direttive generali:

50-100 mg/kg di peso/giorno, ripartiti in 3-4 dosi singole, ossia

Peso

Età circa

Possibile posologia giornaliera

≤5 kg

≤3 mesi

3-4× 100 mg

6-7 kg

3-6 mesi

4× 100 mg o 3× 200 mg

8-10 kg

6-12 mesi

3-4× 200 mg

11-15 kg 1-3 anni

4× 200 mg o 3× 400 mg

16-20 kg 3-6 anni

3-4× 400 mg

21-25 kg 6-8 anni

3-4× 400 mg

26-30 kg 8-10 anni

4× 400 mg

31-40 kg 10-12 anni

4× 400 mg

Malattia di Lyme

50 mg/kg di peso/24 ore in presenza di eritema migrante.

Prevenzione dell'endocardite

Adulti e bambini sopra i 10 anni: si devono prendere 3 g in dose unica circa 1 ora prima

dell'intervento che potrebbe provocare un'infezione batterica.

Bambini fino ai 10 anni: metà della dose per adulti.

Istruzione speciale riguardante la posologia

Insufficienza renale (= cattivo funzionamento dei reni)

Se soffre di insufficienza renale deve informarne il medico, che le prescriverà allora una posologia

adeguata al suo caso personale, che può differire dallo schema posologico summenzionato.

Quando si è iniziata una terapia con antibiotici bisogna effettuarla per tutta la durata prescritta dal

medico.

Spesso i sintomi della malattia scompaiono prima che l'infezione sia completamente guarita. Se la

terapia ha una durata insufficiente o se la si smette troppo presto può conseguirne una ricaduta della

malattia.

Non modifichi di propria iniziativa la posologia prescritta o la durata della terapia. Se ritiene che

l'azione del medicamento sia troppo debole o troppo forte ne parli al suo medico o al suo farmacista.

Preparazione della sospensione

Normalmente la sospensione viene preparata dal farmacista. Se non fosse stata preparata bisogna

aggiungere al polvere acqua del rubinetto, procedendo come segue:

Amoxicillina Spirig HC 200 mg/4 ml

Agitare il flacone con la polvere. Aggiungere con cautela acqua dal rubinetto (94 ml) arrivando fino

alla linea sull'etichetta. Agitare bene e lasciar riposare per breve tempo. Se necessario aggiungere

ancora acqua dal rubinetto fino ad arrivare alla linea sul flacona. Si ottengono così 100 ml di

sospensione pronta all'uso.

Agitare la sospensione ogni volta prima dell'uso.

In casa di trattamento di bambini piccoli si deve notare che la sospensione preparata si conserva 10

giorni al massimo.

Prelievo della sospensione pronta all'uso con la siringa dosatrice

·Agitare il flaconcino prima di ciascun prelievo.

·Immergere la siringa dosatrice nel flaconcino.

·Tirare lentamente verso l'alto lo stantuffo della siringa fino al numero di millilitri prescritto (ml)

tirare verso l'alto. Se la sospensione prelevata contiene bollicine d'aria, premere di nuovo lo stantuffo

della siringa dosatrice e aspirare di nuovo lentamente.

Somministrazione della sospensione pronta all'uso mediante la siringa dosatrice

La sospensione si può somministrare direttamente in bocca dalla siringa dosatrice oppure mettere in

un cucchiaio da tavola o da tè per assumerla. In caso di somministrazione direttamente in bocca il

paziente deve stare seduto col tronco in posizione verticale.

Chiudere bene il flacone ogni volta dopo l'uso. Dopo il prelievo pulire la siringa dosatrice con acqua

limpida riempiendola e vuotandola più volte.

Quali effetti collaterali può avere l'Amoxicillina Spirig HC 200 mg/4 ml?

In seguito all'assunzione dell'Amoxicillina Spirig HC 200 mg/4 ml possono manifestarsi i seguenti

effetti collaterali:

disturbi digestivi come disturbi di stomaco, nausea o diarrea. Possono pure verificarsi reazioni quali

vomito, conati di vomito, dolori di ventre, inappetenza, meteorismo e infiammazione della lingua o

della mucosa orale.

Assumendo l'Amoxicillina Spirig HC 200 mg/4 ml all'inizio dei pasti i disturbi gastrointestinali sono

meno frequenti.

Coll'Amoxicillina Spirig HC 200 mg/4 ml reazioni allergiche come quelle descritte in seguito sono

frequenti come con tutti i medicamenti del gruppo delle penicilline.

Possono verificarsi eruzioni sulla pelle, arrossamenti cutanei, prurito e orticaria. Micosi (infezioni da

funghi microscopici) della pelle/delle mucose sono state osservate molto raramente.

Raramente possono manifestarsi eccitazione, ansia, insonnia, confusione, modificazioni del

comportamento, stordimento e disturbi della sensibilità.

Molto raramente sono stati osservati sensazioni di vertigini, convulsioni e ipercinesia (eccessiva

motilità), alterazioni del quadro ematologico, prolungamento della durata della coagulazione e del

tempo di protrombina, infiammazione del fegato (epatite), infiammazione dei reni e disfunzioni

renali.

Dopo l'assunzione della sospensione sono stati descritti dei cambiamenti di colore superficiali dei

denti. Di solito questo fenomeno scompare lavando i denti.

Molto raramente è stata osservata una patina nera sulla lingua.

Quando si somministra amoxicillina a bambini piccoli da 0 a 9 mesi d'età non si possono escludere

dei danni allo smalto (p.es. striature bianche, cambiamento di colore) dei denti incisivi definitivi.

Molto raramente sono stati osservati sintomi simil-influenzali con eruzione cutanea, febbre,

ghiandole gonfie e risultati anormali degli esami del sangue (inclusi aumento del numero di globuli

bianchi (eosinofilia) e innalzamento degli enzimi epatici) (Reazione da farmaco con eosinofilia e

sintomi sistemici (DRESS)) (vedi «Quando è richiesta prudenza nella somministrazione

dell'Amoxicillina Spirig HC 200 mg/4 ml?»).

Sono stati riferiti rari casi di ittero. Sono stati osservati casi isolati di meningite asettica.

Consulti subito il medico se si manifestano:

·orticaria, estesa eruzione sulla pelle; arrossamenti cutanei;

·colorazione giallastra della pelle o del bianco degli occhi;

·improvvisi dolori di ventre o vomito;

·diarrea grave, sanguinolenta o persistente;

·problemi respiratori sotto forma di crisi d'asma e raffreddore da fieno.

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

Di che altro occorre tener conto?

Conservare fuori dalla portata dei bambini.

Conservare Amoxicillina Spirig HC 200 mg/4 ml polvere nella confezione originale, a temperature

non superiori a 25 °C, protetto dall'umidità e fuori dalla portata dei bambini.

La sospensione ricostituita può essere conservata in frigorifero (2-8 °C) per 10 giorni.

I medicamenti non devono essere utilizzati oltre la data indicata con «EXP» sul contenitore.

A cura ultimata porti la confezione del medicamento col contenuto rimanente a chi gliel'aveva

dispensata (medico o farmacista) per l'eliminazione conforme alle esigenze.

Il medico o il farmacista, che sono in possesso di documentazione professionale dettagliata, possono

darle ulteriori informazioni.

Cosa contiene l'Amoxicillina Spirig HC 200 mg/4 ml?

Amoxicillina Spirig HC 200 mg / 4 ml poudere per la preparazione di una sospensione4 ml di

sospensione pronta all'uso contengono: 200 mg di amoxicillina anidra sotto forma di amoxicillina

triidrato; Diossido di silicio, silice colloidale, crospovidone, gomma di xanthan, aromatizzanti:

vanillina e altri, acesulfame di potassio e saccarina sodica.

Numero dell’omologazione

66700 sospensione (Swissmedic).

Dov'è ottenibile l'Amoxicillina Spirig HC 200 mg/4 ml? Quali confezioni sono disponibili?

In farmacia, dietro presentazione della prescrizione medica non rinnovabile.

Flacone con polvero per 100 ml di sospensione orale con l'aroma di fragola (con siringa dosatrice da

6 ml, con graduazione a intervalli di 0,5 ml).

Titolare dell’omologazione

Spirig HealthCare SA, 4632 Egerkingen.

Questo foglietto illustrativo è stato controllato l'ultima volta nel gennaio 2018 dall'autorità

competente in materia di medicamenti (Swissmedic).

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Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

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

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

9-11-2018

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

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

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

Health Canada

7-11-2018

Nature's Ultimate recalls NuWrench and NuStainless Products

Nature's Ultimate recalls NuWrench and NuStainless Products

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

Health Canada

7-11-2018

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

Murray Wholesale Cash & Carry recalls King Universal Butane Fuel

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

Health Canada

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Vanpak Limited recalls David Ross Extra purified Butane gas

Vanpak Limited recalls David Ross Extra purified Butane gas

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

Health Canada

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

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

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

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

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

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

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

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

Health Canada

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

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

Health Canada

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

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

Health Canada

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

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

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

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

Health Canada

18-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

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

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Health Canada

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

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

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

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