MCP-AbZ 1 mg/ml Lösung zum Einnehmen

Hauptinformation

  • Handelsname:
  • MCP-AbZ 1 mg/ml Lösung zum Einnehmen
  • Darreichungsform:
  • Lösung zum Einnehmen
  • Zusammensetzung:
  • Metoclopramidhydrochlorid (Ph.Eur.) 1.18mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • MCP-AbZ 1 mg/ml Lösung zum Einnehmen
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 92720.00.00
  • Letzte Änderung:
  • 09-12-2018

Packungsbeilage: zusammensetzung, kinische angaben, nebenwirkungen, wechselwirkungen, dosierung, schwangerschaft, stillzeit

Gebrauchsinformation: Information für Anwender

MCP-AbZ 1 mg/ml Lösung zum Einnehmen

Wirkstoff: Metoclopramid

Lesen Sie die gesamte Packungsbeilage sorgfältig durch, bevor Sie mit der Einnahme dieses

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Heben Sie die Packungsbeilage auf. Vielleicht möchten Sie diese später nochmals lesen.

Wenn Sie weitere Fragen haben, wenden Sie sich an Ihren Arzt oder Apotheker.

Dieses Arzneimittel wurde Ihnen persönlich verschrieben. Geben Sie es nicht an Dritte weiter.

Es kann anderen Menschen schaden, auch wenn diese die gleichen Beschwerden haben wie Sie.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt

auch für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Siehe Abschnitt

Was in dieser Packungsbeilage steht

1. Was ist

MCP-AbZ

und wofür wird es angewendet?

2. Was sollten Sie vor der Einnahme von

MCP-AbZ

beachten?

3. Wie ist

MCP-AbZ

einzunehmen?

4. Welche Nebenwirkungen sind möglich?

5. Wie ist

MCP-AbZ

aufzubewahren?

6. Inhalt der Packung und weitere Informationen

1.

Was ist MCP-AbZ und wofür wird es angewendet?

MCP-AbZ

ist ein Mittel gegen Erbrechen (Antiemetikum). Es enthält einen Wirkstoff mit der

Bezeichnung „Metoclopramid“. Dieser wirkt in dem Teil Ihres Gehirns, der Sie davor schützt, dass

Ihnen schlecht wird (Übelkeit) oder Sie sich übergeben müssen (Erbrechen).

Erwachsene

MCP-AbZ

wird bei Erwachsenen eingesetzt:

zur Vorbeugung von nach einer Chemotherapie verzögert auftretender Übelkeit und verzögert

auftretendem Erbrechen,

zur Vorbeugung gegen Übelkeit und Erbrechen, die durch Strahlentherapie verursacht werden,

zur Behandlung von Übelkeit und Erbrechen, einschließlich Übelkeit und Erbrechen, die in

Zusammenhang mit einer Migräne auftreten können. Metoclopramid kann im Falle einer

Migräne mit oralen Schmerzmitteln eingenommen werden, um die Wirkung der Schmerzmittel

zu erhöhen.

Kinder und Jugendliche

MCP-AbZ

wird bei Kindern und Jugendlichen (im Alter von 1-18 Jahren) nach einer Chemotherapie

zur Vorbeugung von verzögert auftretender Übelkeit und verzögert auftretendem Erbrechen

angewendet, wenn andere Behandlungen versagen oder nicht in Frage kommen.

2.

Was sollten Sie vor der Einnahme von MCP-AbZ beachten?

MCP-AbZ darf nicht eingenommen werden,

wenn Sie allergisch gegen Metoclopramid, Natriummethyl-4-hydroxybenzoat (Ph.Eur.),

Natriumpropyl-4-hydroxybenzoat (Ph.Eur.) oder einen der in Abschnitt 6. genannten sonstigen

Bestandteile dieses Arzneimittels sind.

wenn Sie Blutungen, Einengungen oder einen Riss (Perforation) in Ihrem Magen oder Darm

haben.

wenn bei Ihnen ein seltener Tumor in der Nebenniere vermutet wird oder nachgewiesen wurde

(Phäochromozytom).

wenn Sie unwillkürliche Muskelkrämpfe (Spätdyskinesie) haben oder jemals hatten, die

medikamentös behandelt wurden.

wenn Sie an Epilepsie leiden.

wenn Sie an der Parkinson-Krankheit leiden.

wenn Sie Levodopa (ein Wirkstoff gegen die Parkinson-Krankheit) oder dopaminerge

Wirkstoffe einnehmen (siehe „Einnahme von

MCP-AbZ

zusammen mit anderen

Arzneimitteln“).

wenn Sie abnorme Blutfarbstoffwerte (Methämoglobinämie) oder einen NADH-Cytochrom-

b5-Reduktase-Mangel haben oder jemals hatten.

Geben Sie

MCP-AbZ

nicht Kindern unter 1 Jahr (siehe nachfolgend „Kinder und Jugendliche“).

Nehmen Sie

MCP-AbZ

nicht ein, wenn irgendeine der oben genannten Situationen auf Sie zutrifft.

Sollten Sie sich nicht sicher sein, sprechen Sie mit Ihrem Arzt, Apotheker oder dem medizinischen

Fachpersonal, bevor Sie

MCP-AbZ

einnehmen.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie

MCP-AbZ

einnehmen, wenn:

Sie schon einmal einen abnormen Herzschlag (QT-Intervall-Verlängerung) oder andere

Herzprobleme hatten.

Sie Probleme mit den Salzspiegeln (Kalium, Natrium und Magnesium) in Ihrem Blut haben.

Sie andere Arzneimittel einnehmen oder anwenden, die Auswirkungen auf Ihren Herzschlag

haben.

Sie an Erkrankungen des Nervensystems leiden.

Sie Probleme mit der Leber oder den Nieren haben. Es kann erforderlich sein, die Dosis zu

reduzieren (siehe Abschnitt 3. „Wie ist

MCP-AbZ

einzunehmen?“).

Ihr Arzt kann Blutuntersuchungen durchführen, um die Blutfarbstoffspiegel (Hämoglobinspiegel)

Ihres Blutes zu prüfen. In Fällen abnormer Werte (Methämoglobinämie) muss die Behandlung sofort

und dauerhaft abgebrochen werden.

Sie müssen nach jeder Metoclopramid-Einnahme selbst im Fall von Erbrechen und dem Abstoßen des

Arzneimittels mindestens 6 Stunden warten, bevor Sie die nächste Dosis einnehmen, um eine

Überdosis zu vermeiden.

Aufgrund des Risikos unwillkürlicher Muskelkrämpfe dürfen Sie die

maximal 3-monatige

Behandlungsdauer

nicht überschreiten.

Kinder und Jugendliche

Bei Kindern und jungen Erwachsenen können unkontrollierbare Bewegungen (extrapyramidale

Erkrankung) auftreten. Das Arzneimittel darf aufgrund des erhöhten Risikos unkontrollierbarer

Bewegungen nicht bei Kindern unter 1 Jahr angewendet werden (siehe oben „

MCP-AbZ

darf nicht

eingenommen werden“).

Einnahme von MCP-AbZ zusammen mit anderen Arzneimitteln

Informieren Sie Ihren Arzt oder Apotheker oder das medizinische Fachpersonal, wenn Sie andere

Arzneimittel einnehmen/anwenden, kürzlich andere Arzneimittel eingenommen/angewendet haben

oder beabsichtigen, andere Arzneimittel einzunehmen/anzuwenden.

Der Grund hierfür ist, dass andere Arzneimittel die Wirkungsweise von

MCP-AbZ

beeinflussen

können oder dass

MCP-AbZ

Auswirkungen auf die Wirkung der anderen Arzneimittel haben kann.

Dazu gehören:

Levodopa und andere Arzneimittel zur Behandlung der Parkinson-Krankheit (siehe oben

MCP-AbZ

darf nicht eingenommen werden“)

Anticholinergika (Arzneimittel zur Linderung von Magenkrämpfen oder Spasmen)

Morphinderivate (Arzneimittel zur Behandlung starker Schmerzen)

Arzneimittel mit dämpfender Wirkung auf das Nervensystem

sämtliche anderen Arzneimittel zur Behandlung geistig-seelischer Erkrankungen,

Digoxin (Arzneimittel zur Behandlung von Herzschwäche)

Ciclosporin (Arzneimittel zur Behandlung bestimmter Störungen des Immunsystems)

Mivacurium und Suxamethonium (Arzneimittel zur Relaxation der Muskeln)

Fluoxetin und Paroxetin (Arzneimittel zur Behandlung von Depressionen)

Einnahme von MCP-AbZ zusammen mit Alkohol

Während der Behandlung mit Metoclopramid muss auf Alkoholkonsum verzichtet werden, da dieser

die dämpfende Wirkung von

MCP-AbZ

erhöht.

Schwangerschaft und Stillzeit

Wenn Sie schwanger sind oder stillen, oder wenn Sie vermuten, schwanger zu sein, oder

beabsichtigen, schwanger zu werden, fragen Sie vor der Anwendung dieses Arzneimittels Ihren Arzt

oder Apotheker um Rat.

Falls notwendig kann

MCP-AbZ

während der Schwangerschaft eingenommen werden. Ihr Arzt wird

entscheiden, ob Ihnen dieses Arzneimittel gegeben werden sollte oder nicht.

MCP-AbZ

wird nicht empfohlen, wenn Sie stillen, da Metoclopramid in die Muttermilch übergeht und

Auswirkungen auf Ihr Baby haben kann.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Nach der Einnahme von

MCP-AbZ

fühlen Sie sich eventuell schläfrig, schwindlig, oder es können

unkontrollierbare Bewegungsstörungen (Dyskinesie) auftreten, wie Zittern, Zuckungen und

Krümmung sowie eine ungewöhnliche Muskelspannung mit abnormer Körperhaltung (Dystonie). Dies

kann Ihre Sehkraft beeinträchtigen und auch Ihre Verkehrstüchtigkeit und Fähigkeit, Maschinen zu

bedienen, einschränken.

MCP-AbZ enthält Natriummethyl-4-hydroxybenzoat (Ph.Eur.) und Natriumpropyl-4-

hydroxybenzoat (Ph.Eur.).

Natriummethyl-4-hydroxybenzoat (Ph.Eur.) und Natriumpropyl-4-hydroxybenzoat (Ph.Eur.) können

Überempfindlichkeitsreaktionen, auch Spätreaktionen, hervorrufen.

3. Wie ist MCP-AbZ einzunehmen?

Nehmen Sie dieses Arzneimittel

immer genau nach Absprache mit Ihrem Arzt oder Apotheker ein.

Fragen Sie bei Ihrem Arzt oder Apotheker nach, wenn Sie sich nicht sicher sind.

Sämtliche Indikationen (erwachsene Patienten)

Die empfohlene Einzeldosis beträgt 10 mg

(entsprechend 10 ml Lösung oder zwei vollen 5

Applikationsspritzen)

und kann bis zu dreimal täglich gegeben werden.

Die maximale empfohlene Tagesdosis beträgt 30 mg oder 0,5 mg/kg Körpergewicht.

Die maximale empfohlene Behandlungsdauer beträgt 5 Tage.

Kinder und Jugendliche

Zur Vorbeugung von nach einer Chemotherapie verzögert auftretender Übelkeit und verzögert

auftretendem Erbrechen (Kinder und Jugendliche im Alter von 1-18 Jahren)

Die empfohlene Dosis beträgt 0,1 bis 0,15 mg/kg Körpergewicht. Diese kann bis zu dreimal täglich

eingenommen werden (orale Anwendung).

Die maximale Dosis innerhalb von 24 Stunden beträgt 0,5 mg/kg Körpergewicht.

Dosierungstabelle

Alter

Körpergewicht

Dosierung

Volumen

Häufigkeit

1-3 Jahre

10-14 kg

1 mg

1 ml

Bis zu dreimal täglich

3-5 Jahre

15-19 kg

2 mg

2 ml

Bis zu dreimal täglich

5-9 Jahre

20-29 kg

2,5 mg

2,5 ml

Bis zu dreimal täglich

9-18 Jahre

30-60 kg

5 mg

5 ml

Bis zu dreimal täglich

15-18 Jahre

Mehr als 60 kg

10 mg

10 ml

2 volle

Applikations-

spritzen)

Bis zu dreimal täglich

Zur Vorbeugung von nach Chemotherapie verzögert auftretender Übelkeit und verzögert auftretendem

Erbrechen sollten Sie dieses Arzneimittel nicht länger als 5 Tage einnehmen.

Anleitung zur korrekten Anwendung der Applikationsspritze:

Zur genauen Dosierung liegt der Packung eine 5 ml-Applikationsspritze mit Dosierskala bei.

1 ml Lösung zum Einnehmen entspricht 1 mg Metoclopramid.

Eine volle Applikationsspritze enthält 5 ml Lösung entsprechend 5 mg Metoclopramid.

Zur Anwendung gehen Sie bitte folgendermaßen vor:

1. Öffnen Sie die Flasche, indem Sie den kindergesicherten Verschluss nach unten drücken und ihn

gleichzeitig in Pfeilrichtung drehen.

2. Führen Sie die Applikationsspritze so in den Flaschenhals ein, dass sie fest sitzt.

3. Drehen Sie die Flasche zum Füllen der Applikationsspritze auf den Kopf. Halten Sie die

Applikationsspritze fest und ziehen Sie den Kolben sachte nach unten, um die Lösung bis zur

gewünschten Markierung oder bis zum gewünschten Volumen aufzuziehen.

4. Drehen Sie die Flasche wieder um und ziehen Sie die Applikationsspritze unter vorsichtigem Hin-

und Herdrehen aus dem Flaschenhals heraus.

5. Drücken Sie mit dem Kolben langsam die Flüssigkeit aus der Applikationsspritze heraus in den

Mund oder in ein Glas Wasser.

Schrauben Sie nach dem Gebrauch den Deckel fest zu, damit der kindersichere Verschluss wieder

einrastet.

Ziehen Sie die Spritze nach dem Gebrauch auseinander (d. h. nehmen Sie den Kolben aus dem

Spritzenzylinder heraus). Spülen Sie die Spritze sorgfältig mit warmem Wasser aus und lassen Sie sie

trocknen, damit sie für die Verabreichung der nächsten Dosis bereit ist.

Art der Anwendung

MCP-AbZ

wird vor den Mahlzeiten mit ausreichend Flüssigkeit (z. B. 1 Glas Wasser) eingenommen.

Sie müssen nach jeder Metoclopramid-Einnahme selbst im Fall von Erbrechen und dem Abstoßen des

Arzneimittels mindestens 6 Stunden warten, bevor Sie die nächste Dosis einnehmen, um eine

Überdosis zu vermeiden.

Ältere Personen

Eine Reduzierung der Dosis kann in Abhängigkeit von der Nieren- und Leberfunktion sowie vom

allgemeinen Gesundheitszustand erforderlich sein.

Erwachsene mit Störung der Nierenfunktion

Sprechen Sie mit Ihrem Arzt, wenn Sie Nierenprobleme haben. Die Dosis muss reduziert werden,

wenn Sie eine mäßige bis schwere Nierenfunktionsstörung haben.

Erwachsene mit Störung der Leberfunktion

Sprechen Sie mit Ihrem Arzt, wenn Sie Leberprobleme haben. Die Dosis muss reduziert werden, wenn

Sie eine schwere Leberfunktionsstörung haben.

Kinder und Jugendliche

Metoclopramid darf nicht bei Kindern unter 1 Jahr angewendet werden (siehe Abschnitt 2. „

MCP-AbZ

darf nicht eingenommen werden“).

Wenn Sie eine größere Menge von MCP-AbZ eingenommen haben, als Sie sollten

Wenden Sie sich unverzüglich an Ihren Arzt oder Apotheker. Sie können unter unkontrollierbaren

Bewegungen leiden (extrapyramidale Erkrankung), sich schläfrig fühlen, Schwierigkeiten mit Ihrem

Bewusstsein haben, verwirrt sein und Halluzinationen und Herzprobleme bekommen. Falls

erforderlich, kann Ihr Arzt diese Symptome behandeln.

Wenn Sie die Einnahme von MCP-AbZ vergessen haben

Nehmen Sie nicht die doppelte Menge ein, wenn Sie die vorherige Einnahme vergessen haben.

Wenn Sie weitere Fragen zur Anwendung dieses Arzneimittels haben, wenden Sie sich an Ihren Arzt

oder Apotheker.

4. Welche Nebenwirkungen sind möglich?

Wie alle Arzneimittel kann auch dieses Arzneimittel Nebenwirkungen haben, die aber nicht bei jedem

auftreten müssen.

Brechen Sie die Behandlung ab und sprechen Sie unverzüglich mit Ihrem Arzt, Apotheker oder dem

medizinischen Fachpersonal, wenn Sie während der Einnahme des Arzneimittels eins der folgenden

Anzeichen bemerken:

unkontrollierbare Bewegungen (häufig unter Einbeziehung des Kopfes oder des Nackens). Dies

kann bei Kindern und jungen Erwachsenen und besonders dann auftreten, wenn hohe

Dosierungen angewendet werden. Diese Anzeichen treten normalerweise zu Beginn der

Behandlung auf und können selbst nach nur einer einzigen Anwendung auftreten. Diese

Bewegungen enden, wenn sie ordnungsgemäß behandelt werden.

hohes Fieber, hoher Blutdruck, Krämpfe, Schweißausbruch, vermehrte Speichelbildung. Dies

können Anzeichen für eine Erkrankung mit der Bezeichnung neuroleptisches malignes Syndrom

sein.

Jucken oder Hautausschlag, Schwellung des Gesichts, der Lippen oder des Halses,

Schwierigkeiten beim Atmen. Dies können Anzeichen einer allergischen Reaktion sein, die

möglicherweise schwerwiegend ist.

Sehr häufig

(kann mehr als 1 von 10 Behandelten betreffen)

Gefühl von Schläfrigkeit

Häufig

(kann bis zu 1 von 10 Behandelten betreffen)

Depression

unkontrollierbare Bewegungen wie Ticks, Zittern, Drehbewegungen oder Muskelkontraktionen

(Steifheit, Starre)

Ähnliche Symptome wie bei der Parkinson-Krankheit (Starre, Tremor)

Gefühl von Ruhelosigkeit

Abnahme des Blutdrucks (insbesondere bei intravenöser Anwendung)

Durchfall

Schwächegefühl

Gelegentlich

(kann bis zu 1 von 100 Behandelten betreffen)

erhöhter Spiegel eines Hormons namens Prolaktin, das milchige Absonderungen aus der

Brustdrüse bei Männern und nicht stillenden Frauen auslösen kann

Störung der Regelblutung

Halluzination

Bewusstseinsstörungen

Langsamer Herzschlag (besonders bei intravenöser Anwendung)

Allergie

Selten

(kann bis zu 1 von 1.000 Behandelten betreffen)

Zustand der Verwirrtheit

Krampfanfälle (besonders bei epileptischen Patienten)

Nicht bekannt

(Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)

abnorme Blutfarbstoffwerte (Hämoglobin): kann die Farbe der Haut verändern

abnormes Wachstum von Brüsten (Gynäkomastie)

unfreiwillige Muskelkrämpfe nach längerer Anwendung, besonders bei älteren Patienten

hohes Fieber, hoher Blutdruck, Krampfanfälle, Schweißausbruch, vermehrte Speichelbildung.

Dies können Anzeichen für eine Erkrankung mit der Bezeichnung malignes neuroleptisches

Syndrom sein

Veränderungen des Herzschlags, die im Elektrokardiogramm (EKG-Untersuchung) erkennbar

sind

Herzstillstand (besonders bei der Anwendung als Injektion)

Schock (starker Blutdruckabfall) (besonders bei der Anwendung als Injektion)

Ohnmacht (besonders bei intravenöser Gabe)

allergische Reaktion, die schwerwiegend sein kann (besonders bei intravenöser Verabreichung)

sehr hoher Blutdruck

Meldung von Nebenwirkungen

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt oder Apotheker. Dies gilt auch

für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind. Sie können

Nebenwirkungen auch direkt dem Bundesinstitut für Arzneimittel und Medizinprodukte, Abt.

Pharmakovigilanz, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Website: www.bfarm.de anzeigen.

Indem Sie Nebenwirkungen melden, können Sie dazu beitragen, dass mehr Informationen über die

Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5. Wie ist MCP-AbZ aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf dem Umkarton und dem Etikett nach „Verwendbar bis“

angegebenen Verfalldatum nicht mehr verwenden. Das Verfalldatum bezieht sich auf den letzten Tag

des angegebenen Monats.

Nicht über 25 °C lagern.

Das Arzneimittel ist nach dem Öffnen 6 Monate, aber höchstens bis zu dem auf dem Umkarton und

dem Etikett genannten Verfalldatum haltbar.

6.

Inhalt der Packung und weitere Informationen

Was MCP-AbZ enthält

Der Wirkstoff ist Metoclopramid (als Metoclopramidhydrochlorid-Monohydrat).

1 ml Lösung zum Einnehmen enthält 1,2 mg Metoclopramidhydrochlorid (Ph.Eur.)

entsprechend 1,0 mg Metoclopramid.

Die sonstigen Bestandteile sind:

Natriummethyl-4-hydroxybenzoat (Ph.Eur.), Natriumpropyl-4-hydroxybenzoat (Ph.Eur.),

Saccharin-Natrium, Natriumcyclamat, Natriummonohydrogenphosphat-Dodecahydrat

(Ph.Eur.), Salzsäure 25 %, gereinigtes Wasser.

Wie MCP-AbZ aussieht und Inhalt der Packung

Klare, farblose bis leicht gelbliche Lösung.

MCP-AbZ

ist in Packungsgrößen mit 30, 50, 100, 150 ml, 2 x 100 ml und 2 x 150 ml Lösung zum

Einnehmen in Flaschen aus braunem Glas erhältlich.

Jede Packung enthält eine skalierte 5 ml-Applikationsspritze für Zubereitungen zum Einnehmen. Ein

Teilstrich entspricht 0,1 ml Lösung.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer

A

Z

-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Hersteller

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Dieses Arzneimittel ist in den Mitgliedsstaaten des Europäischen Wirtschaftsraumes (EWR) unter den

folgenden Bezeichnungen zugelassen:

Deutschland: MCP-AbZ 1 mg/ml Lösung zum Einnehmen

Diese Packungsbeilage wurde zuletzt überarbeitet im Januar 2017

A

Z-Pharma wünscht Ihnen gute Besserung!

Versionscode: Z05

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EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Risk assessment of new sequencing information for genetically modified soybean A2704‐12

Published on: Mon, 26 Nov 2018 The GMO Panel has previously assessed genetically modified (GM) soybean A2704‐12. This soybean was found to be as safe and nutritious as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 5 June 2018, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soybean A2704‐12 and to indicate whether the previous c...

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Hazard identification and ranking for poultry at slaughter

Hazard identification and ranking for poultry at slaughter

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Extensive Literature Search, Selection for Relevance and Data Extraction of Studies Related to the Toxicity of PCDD/Fs and DL‐PCBs in Experimental Animals

Published on: Tue, 20 Nov 2018 Polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDFs) and dioxin‐like polychlorinated biphenyls (DL‐PCBs) are detected ubiquitously in the environment, diet and human tissues. The European Food Safety Authority (EFSA) CONTAM Panel received a mandate from the European Commission for a scientific opinion on the risks for human and animal health related to the presence of dioxins and DL‐PCBs in food and feed. To support preparatory work for the hazard i...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Relevance of new scientific information (Santos‐Vigil et al., 2018*) in relation to the risk assessment of genetically modified crops with Cry1Ac

Relevance of new scientific information (Santos‐Vigil et al., 2018*) in relation to the risk assessment of genetically modified crops with Cry1Ac

Published on: Wed, 14 Nov 2018 Following a request from the European Commission, EFSA assessed the scientific publication by Santos‐Vigil et al. (2018). The outstanding question was whether or not the new scientific information contains elements that could lead the EFSA GMO Panel to reconsider the outcome of its previous risk assessments on genetically modified crops expressing Cry1Ac protein. Santos‐Vigil et al. (2018) investigated the allergenic potential and immunological effects of the Cry1Ac protei...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene 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 uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Assessment of genetically modified soybean MON 89788 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐011)

Published on: Fri, 16 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐011 under Regulation (EC) No 1829/2003 from Monsanto Europe, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified soybean MON 89788, for food and feed uses, excluding cultivation within the European Union....

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tau‐fluvalinate. To assess the occurrence of tau‐fluvalinate residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member St...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

Published on: Wed, 14 Nov 2018 The technical report reflects the outcome of the discussions and agreements that were reached in the pesticides peer review meeting on residues and maximum residue levels regarding the principles and guidance for application of the proportionality concept in the risk assessment methodologies used at European level for the estimation of the maximum residue levels for pesticides. In addition, practical experiences on the use of the proportionality approach gained by EFSA hav...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M 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 uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

12-11-2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

10-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

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

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

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

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

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

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

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

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

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

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

15-10-2018

EFSA Focal Points: a decade of networking for European food safety

EFSA Focal Points: a decade of networking for European food safety

EFSA Focal Points: a decade of networking for European food safety

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

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

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

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

21-11-2018

Epivir 10 mg/ml Lösung zum Einnehmen

Rote - Liste

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

25-10-2018

REBETOL 40 mg/ml Lösung zum Einnehmen

Rote - Liste

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety