Thrombo ASS 75 mg magensaftresistente Tabletten

Hauptinformation

  • Handelsname:
  • Thrombo ASS 75 mg magensaftresistente Tabletten
  • Darreichungsform:
  • magensaftresistente Tablette
  • Zusammensetzung:
  • Acetylsalicylsäure (Ph.Eur.) 75.mg
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • Thrombo ASS 75 mg magensaftresistente Tabletten
    Deutschland
  • Sprache:
  • Deutsch

Weitere Informationen

Status

  • Quelle:
  • BfArM - Bundesinstitut für Arzneimittel und Medizinprodukte
  • Zulassungsnummer:
  • 95661.00.00
  • Letzte Änderung:
  • 15-11-2018

Packungsbeilage

Gebrauchsinformation: Information für Patienten

Thrombo ASS 75 mg magensaftresistente Tabletten

Acetylsalicylsäure

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

dieses Arzneimittels beginnen, denn sie enthält wichtige Informationen.

Nehmen Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben bzw.

genau nach Anweisung Ihres Arztes oder Apothekers ein.

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

Fragen Sie Ihren Apotheker, wenn Sie weitere Informationen oder einen Rat

benötigen.

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 4.

Wenn Sie sich nicht besser oder gar schlechter fühlen, wenden Sie sich an Ihren Arzt.

Was in dieser Packungsbeilage steht

Was ist Thrombo ASS und wofür wird es angewendet?

Was müssen Sie vor der Einnahme von Thrombo ASS beachten?

Wie ist Thrombo ASS einzunehmen?

Welche Nebenwirkungen sind möglich?

Wie ist Thrombo ASS aufzubewahren?

Inhalt der Packung und weitere Informationen

1. Was ist Thrombo ASS und wofür wird es angewendet

Thrombo ASS enthält Acetylsalicylsäure, die in geringer Dosierung zu einer Gruppe von

Medikamenten gehört, die Thrombozytenaggregationshemmer genannt werden. Thrombozyten

sind winzige Zellen im Blut, die das Blut zum Gerinnen bringen und zu Thrombosen führen

können. Das Auftreten eines Blutgerinnsels in einer Arterie stoppt den Blutfluss und schneidet

die Sauerstoffzufuhr ab. Wenn dies im Herzen passiert, kann es zu einem Herzinfarkt oder einer

Angina Pectoris kommen; im Gehirn kann es zu einem Schlaganfall führen.

Thrombo ASS wird angewendet, um das Risiko der Entstehung von Blutgerinnseln zu

verringern und folgenden Erkrankungen vorzubeugen:

Herzinfarkt

Schlaganfall

Probleme des Herz-Kreislauf-Systems bei Patienten mit stabiler oder instabiler Angina

Pectoris (Schmerzen im Brustbereich).

Thrombo ASS wird ebenfalls angewendet, um der Entstehung von Blutgerinnseln nach

bestimmten Arten von herzchirurgischen Eingriffen zur Erweiterung oder zum Offenhalten der

Blutgefäße vorzubeugen.

Dieses Arzneimittel eignet sich nicht für Notfallsituationen. Es kann nur zur Vorbeugung

eingenommen werden.

2. Was sollten Sie vor der Einnahme von Thrombo ASS beachten?

Thrombo ASS darf nicht eingenommen werden

wenn Sie allergisch gegen Acetylsalicylsäure oder einen der in Abschnitt 6. genannten

sonstigen Bestandteile dieses Arzneimittels sind,

wenn Sie gegen andere Salicylate oder nichtsteroidale Entzündungshemmer (NSAR)

allergisch sind. NSAR werden oft zur Behandlung von Arthritis (Gelenkentzündung) oder

Rheuma und Schmerzen angewendet,

wenn Sie auf die Einnahme von Salicylaten oder NSAR mit Asthmaanfällen oder mit dem

Anschwellen bestimmter Körperteile, z.B. Gesicht, Lippen, Rachen oder Zunge

(Angioödeme) reagiert haben,

wenn

derzeit

Geschwür

Magen

oder

Dünndarm

haben oder

Vergangenheit hatten oder eine andere Art von Blutung wie bei einem Schlaganfall haben

oder hatten,

bei niedriger Gerinnungsneigung des Blutes,

bei schweren Leber- oder Nierenproblemen,

bei schweren Herzleiden, eventuell verbunden mit Atemnot oder Knöchelschwellung,

in den letzten 3 Monaten der Schwangerschaft in einer Dosierung von mehr als 100 mg pro

Tag (siehe Abschnitt „Schwangerschaft und Stillzeit“),

wenn Sie ein Arzneimittel mit dem Namen Methotrexat (angewendet z.B. bei

Krebserkrankungen oder Gelenkrheumatismus) in einer Dosierung von mehr als 15 mg pro

Woche einnehmen.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Thrombo ASS einnehmen, wenn:

Sie Nieren-, Leber oder Herzbeschwerden haben,

wenn Sie Magen- oder Dünndarmprobleme haben oder hatten,

wenn Sie einen unkontrollierten hohen Blutdruck haben,

wenn Sie Asthma, Heuschnupfen, Nasenschleimhautschwellungen (Nasenpolypen)

oder sonstige chronische Atemwegserkrankungen haben; Acetylsalicylsäure kann einen

Asthmaanfall auslösen,

wenn Sie jemals Gicht hatten,

wenn Sie starke Monatsblutungen haben,

wenn Sie an einem Mangel des Enzyms Glucose-6-Phosphat Dehydrogenase (G6PD) leiden.

Wenn Ihre Symptome sich verschlechtern oder wenn bei Ihnen schwere oder unerwartete

Nebenwirkungen auftreten, z.B. ungewöhnliche Blutungssymptome, schwere Hautreaktionen

oder jegliche andere Anzeichen allergischer Reaktionen, müssen Sie sofort einen Arzt aufsuchen

(siehe Abschnitt „Welche Nebenwirkungen sind möglich?“).

Informieren Sie Ihren Arzt, falls bei Ihnen eine Operation ansteht (auch bei kleinen operativen

Eingriffen wie das Ziehen eines Zahnes), da Acetylsalicylsäure eine blutverdünnende Wirkung

hat und es zu einem erhöhten Blutungsrisiko kommen kann.

Sie sollten auf eine ausreichende Flüssigkeitszufuhr achten (Sie könnten durstig sein und einen

trockenen Mund haben), da die Einnahme von Acetylsalicylsäure gleichzeitig zu einer

Verschlechterung der Nierenfunktion führen kann.

Dieses Arzneimittel eignet sich nicht zur Behandlung von Schmerzzuständen und als

fiebersenkendes Mittel.

Sollte einer oder mehrere der oben aufgeführten Punkte auf Sie zutreffen oder sollten Sie sich

diesbezüglich nicht sicher sein, sprechen Sie bitte mit Ihrem Arzt oder Apotheker.

Kinder und Jugendliche

Acetylsalicylsäure kann bei der Verabreichung an Kinder das Reye-Syndrom auslösen. Das

Reye-Syndrom ist eine äußerst seltene Erkrankung, die das Gehirn und die Leber schädigt und

lebensbedrohlich sein kann. Daher darf Thrombo ASS Kindern unter 16 Jahren, außer auf

ärztliche Anweisung, nicht verabreicht werden.

Einnahme von Thrombo ASS zusammen mit anderen

Arzneimitteln

Informieren Sie Ihren Arzt oder Apotheker, wenn Sie andere Arzneimittel einnehmen, kürzlich

andere Arzneimittel eingenommen haben oder beabsichtigen, andere Arzneimittel einzunehmen.

Die Wirkung der nachfolgend genannten Arzneimittel kann bei gleichzeitiger Behandlung mit

Acetylsalicylsäure beeinflusst werden:

blutgerinnungshemmende/Blutgerinnseln vorbeugende oder auflösende Arzneimittel (z.B.

Warfarin, Heparin, Clopidogrel, Alteplase)

Arzneimittel gegen die Abstoßung von Organen nach einer Transplantation (Ciclosporin,

Tacrolimus)

blutdrucksenkende Arzneimittel (z.B. Diuretika und ACE-Hemmer)

herzschlagregulierende Arzneimittel (Digoxin)

Arzneimittel gegen manisch-depressive Erkrankungen (Lithium)

Schmerzmittel und Mittel gegen Entzündungen (z.B. NSAR wie Ibuprofen oder Steroide)

Arzneimittel gegen Gicht (z.B. Probenecid)

Arzneimittel gegen Epilepsie (Valproat, Phenytoin)

Arzneimittel gegen Glaukom (Acetazolamid)

Arzneimittel gegen Krebs oder Gelenkrheumatismus (Methotrexat in einer Dosierung von

weniger als 15 mg pro Woche)

Mittel gegen Diabetes (z.B. Glibenclamid, Insulin)

Arzneimittel zur Behandlung von Depressionen (Selektive Serotonin- Wiederaufnahme-

Hemmer (SSRI) wie Sertralin oder Paroxetin)

Arzneimittel für die Hormonersatztherapie bei Zerstörung oder Entfernung der Nebenniere

oder der Hirnanhangdrüse oder Arzneimittel zur Behandlung von Entzündungen

einschließlich rheumatischer Erkrankungen und Entzündungen des Magen-Darm-Trakts

(Corticosteroide)

Einnahme von Thrombo ASS zusammen mit Nahrungsmitteln, Getränken und Alkohol

Der Genuss von Alkohol kann möglicherweise das Risiko einer Magen-Darm-Blutung sowie

deren Dauer erhöhen.

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.

Schwangere Frauen dürfen Acetylsalicylsäure nicht ohne ärztlichen Rat einnehmen. In den

letzten 3 Monaten der Schwangerschaft dürfen Sie Thrombo ASS nur dann einnehmen, wenn

Ihnen Ihr Arzt dies verordnet und die tägliche Dosis 100 mg nicht überschreitet (siehe Abschnitt

„Thrombo ASS darf nicht eingenommen werden“). Regelmäßige oder hohe Dosen dieses

Arzneimittels

während

letzten

Schwangerschaftsphase

können

schwerwiegende

Komplikationen bei Mutter und Kind auslösen.

Stillende Mütter dürfen Acetylsalicylsäure nicht ohne ärztlichen Rat einnehmen.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Thrombo ASS sollte keinen Einfluss auf Ihre Verkehrstüchtigkeit oder Ihre Fähigkeit zum

Bedienen von Maschinen haben.

Thromobo ASS enthält Lactose

Bitte nehmen Sie Thrombo ASS erst nach Rücksprache mit Ihrem Arzt ein, wenn Ihnen bekannt

ist, dass Sie an einer Zuckerunverträglichkeit leiden.

Thromobo ASS enthält Gelborange S (E110)

Kann allergische Reaktionen hervorrufen.

3. Wie ist Thrombo ASS einzunehmen?

Nehmen Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben bzw.

genau nach der mit Ihrem Arzt oder Apotheker getroffenen Absprache ein. Fragen Sie bei Ihrem

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

Erwachsene

Zur Vorbeugung eines Herzinfarkts:

Die empfohlene Dosis beträgt 75-160 mg 1-mal täglich.

Zur Vorbeugung eines Schlaganfalls:

Die empfohlene Dosis beträgt 75-300 mg 1-mal täglich.

Zur Vorbeugung von Problemen des Herz-Kreislauf-Systems bei Patienten mit stabiler oder

instabiler Angina Pectoris (Schmerzen im Brustbereich):

Die empfohlene Dosis beträgt 75-160 mg 1-mal täglich.

Zur Vorbeugung von Blutgerinnseln nach bestimmten Arten von herzchirurgischen Eingriffen:

Die empfohlene Dosis beträgt 75-160 mg 1-mal täglich.

Thrombo ASS darf ohne ärztlichen Rat nicht in höherer Dosis angewendet werden und dann

sollte die maximale Höchstdosis nicht 300 mg pro Tag überschreiten.

Ältere Patienten

Anwendung wie bei Erwachsenen. Generell sollte Acetylsalicylsäure bei älteren Patienten, die

für Nebenwirkungen anfälliger sind, mit Vorsicht angewendet werden. Die Behandlung sollte in

regelmäßigen Abständen überprüft werden.

Kinder und Jugendliche

Acetylsalicylsäure darf bei Kindern und Jugendlichen unter 16 Jahren nicht ohne ärztliche

Verschreibung angewendet werden (siehe Abschnitt „Besondere Vorsicht bei der Einnahme von

Thrombo ASS ist erforderlich“).

Art der Anwendung

Zum Einnehmen.

Nehmen Sie die Tablette im Ganzen mit ausreichend Flüssigkeit (1/2 Glas Wasser) ein. Wegen

des magensaftresistenten Films sollten die Tabletten nicht zerdrückt, zerbrochen oder zerkaut

werden, da der Tablettenüberzug eine Reizung des Magens verhindert.

Wenn Sie eine größere Menge von Thrombo ASS eingenommen

haben, als Sie sollten

Sollten Sie (oder eine andere Person) versehentlich zu viele Tabletten eingenommen haben,

benachrichtigen Sie bitte sofort Ihren Arzt oder kontaktieren Sie die nächste Notaufnahme.

Zeigen Sie dem Arzt die restlichen Arzneimittel oder die leere Packung.

Symptome einer Überdosis können Ohrenklingeln, Hörprobleme, Kopfschmerzen, Schwindel,

Verwirrtheitszustände, Übelkeit, Erbrechen und Bauchschmerzen sein. Eine hohe Überdosis

kann zu einer schnelleren Atemfrequenz als normal (Hyperventilation), Fieber, übermäßigem

Schwitzen, Ruhelosigkeit, Krämpfen, Halluzinationen, niedrigem Blutzucker, Koma und Schock

führen.

Wenn Sie die Einnahme von Thrombo ASS vergessen haben

Warten Sie bis zur nächsten Einnahme und führen Sie die Behandlung wie normal fort. Nehmen

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

Wenn Sie die Einnahme von Thrombo ASS abbrechen

Beenden Sie die Einnahme von Thrombo ASS nicht ohne Ihren Arzt zu fragen.

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 Thrombo ASS Nebenwirkungen haben, die aber nicht bei

jedem auftreten müssen.

Wenn bei Ihnen eine oder mehrere der folgenden schwerwiegenden Nebenwirkungen

auftreten, stoppen Sie die Einnahme von Thrombo ASS und suchen Sie umgehend einen

Arzt auf:

Plötzliches Keuchen, Anschwellen der Lippen, des Gesichts oder des Körpers,

Hautausschlag, Ohnmacht oder Schluckbeschwerden (schwere allergische Reaktion).

Hautrötungen mit Blasenbildung oder Abschälungen; möglicherweise in Verbindung mit

hohem Fieber und Gelenkschmerzen. Hierbei könnte es sich um ein Erythema multiforme,

das Stevens-Johnson-Syndrom oder das Lyell-Syndrom handeln.

Ungewöhnliche Blutungen wie Bluthusten, Blut im Erbrochenen oder im Urin oder

schwarzer Stuhl.

Weitere Nebenwirkungen:

Häufig (1 bis 10 Behandelte von 100):

Übelkeit, Erbrechen, Durchfall.

Verdauungsstörungen.

Erhöhte Blutungsneigung.

Gelegentlich (1 bis 10 Behandelte von 1.000):

Nesselsucht.

Triefende Nase.

Atembeschwerden.

Selten (1 bis 10 Behandelte von 10.000):

Schwere Blutungen im Magen oder im Darm, Gehirnblutungen; Veränderungen in der

Anzahl der Blutkörperchen.

Krämpfe im Bereich der unteren Atemwege, Asthmaanfall.

Entzündungen in den Blutgefäßen.

Blutergüsse (Einblutungen in die Haut).

Schwere Hautreaktionen wie Ausschläge, auch Erythema multiforme genannt, und dessen

lebensbedrohliche Formen Stevens-Johnson-Syndrom und Lyell-Syndrom.

Überempfindlichkeitsreaktionen wie beispielsweise ein Anschwellen der Lippen, des

Gesichts oder des Körpers oder ein Schock.

Reye-Syndrom (eine sehr seltene Krankheit bei Kindern, welche das Gehirn und die

Leber schädigt (siehe Abschnitt 2 „Kinder und Jugendliche“)).

Ungewöhnlich starke oder lange Monatsblutung

Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten

nicht abschätzbar):

Ohrenklingeln (Tinnitus) oder vermindertes Hörvermögen.

Kopfschmerzen.

Schwindelgefühl.

Magen- oder Dünndarmgeschwüre und -durchbruch.

Verlängerte Blutungszeit.

Nierenfunktionsstörung, akutes Nierenversagen.

Leberfunktionsstörung, Anstieg von Leberenzymen.

Hoher Harnsäurespiegel im Blut oder niedriger Blutzuckerspiegel.

Meldung von Nebenwirkungen

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

auch für Nebenwirkungen, die nicht in dieser Gebrauchsinformation angegeben sind. Sie

können Nebenwirkungen auch direkt anzeigen:

Bundesinstitut für Arzneimittel und Medizinprodukte Abt. Pharmakovigilanz

Kurt-Georg-Kiesinger-Allee 3 D-53175 Bonn

Website: www.bfarm.de

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

die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5. Wie ist Thrombo ASS aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Nicht über 25ºC lagern.

Tablettenbehälter: Nach dem ersten Öffnen 6 Monate haltbar.

Die Blisterpackung in der Originalverpackung aufbewahren, um den Inhalt vor Licht und

Feuchtigkeit zu schützen.

Das Tablettenbehältnis fest verschlossen halten, um den Inhalt vor Licht und Feuchtigkeit zu

schützen.

dürfen

dieses

Arzneimittel

nach

Umkarton

oder

auf dem

Behältnis

angegebenen Verfallsdatum nicht mehr verwenden. Das Verfallsdatum bezieht sich auf den

letzten Tag des angegebenen Monats.

Entsorgen

Arzneimittel

nicht

Abwasser

oder

Haushaltsabfall.

Fragen Sie

Ihren

Apotheker, wie das Arzneimittel zu entsorgen ist, wenn Sie es nicht mehr verwenden. Sie tragen

damit zum Schutz der Umwelt bei.

6. Inhalt der Packung und weitere Informationen

Was Thrombo ASS enthält

Der Wirkstoff ist Acetylsalicylsäure. 1 magensaftresistente Tablette enthält 75 mg

Acetylsalicylsäure.

Die sonstigen Bestandteile sind:

Lactose-Monohydrat, mikrokristalline Cellulose, hochdisperses Siliciumdioxid,

Kartoffelstärke, Talkum, Triacetin, Methacrylsäure-Ethylacrylat-Copolymer,

Polyphenylalkohol (E1203), Titandioxid (E171), Macrogol 3350 (E1521),

Karminsäure (E120), Gelborange S (E110).

Wie Thrombo ASS aussieht und Inhalt der Packung

Pinkfarbene, runde, bikonvexe Filmtabletten mit einem Durchmesser von ungefähr 7,2 mm.

Packungsgrößen:

Blisterpackungen mit 10, 20, 28, 30, 50, 56, 60, 90 und 100 magensaftresistenten Tabletten.

Tablettenbehälter mit 500 und 1000 magensaftresistenten Tabletten.

Es werden möglicherweise nicht alle Packungsgrößen in den Verkehr gebracht.

Pharmazeutischer Unternehmer und Hersteller

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach,

Österreich

Dieses Arzneimittel ist in den Mitgliedstaaten des Europäischen Wirtschaftsraumes

(EWR) unter den folgenden Bezeichnungen zugelassen:

Schweden: Thromboass 75 mg enterotabletter

Diese Packungsbeilage wurde zuletzt überarbeitet am 01.02.2016.

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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

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

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

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

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

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

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

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 evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW 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. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

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

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

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

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

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

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

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

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

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

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

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

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

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

14-11-2018

DuoPlavin® 75 mg/100 mg Filmtabletten

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14-11-2018

Iscover® 75 mg Filmtabletten

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12-11-2018

Clopidogrel AbZ 75 mg Filmtabletten

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12-11-2018

Actonel® 75 mg Filmtabletten

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5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

23-10-2018

Feanolla® 75 Mikrogramm Filmtabletten

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