Lamisil Once

Hauptinformation

  • Handelsname:
  • Lamisil Once Lösung zur Anwendung auf der Haut 1 %
  • Dosierung:
  • 1 %
  • Darreichungsform:
  • Lösung zur Anwendung auf der Haut
  • Verwenden für:
  • Menschen
  • Art der Medizin:
  • allopathic Droge

Dokumenten

  • Information für medizinisches Fachpersonal:
  • Das Informationsblatt für dieses Produkt ist derzeit nicht verfügbar, können Sie eine Anfrage an unseren Kundendienst zu senden und wir werden Sie benachrichtigen, sobald wir in der Lage, um es zu erhalten.


    Fordern Sie die Packungsbeilage für medizinisches Fachpersonal.

Lokalisierung

  • Erhältlich in:
  • Lamisil Once Lösung zur Anwendung auf der Haut 1 %
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • andere antimykotische Produkte für den lokalen Gebrauch

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE291322
  • Letzte Änderung:
  • 12-04-2018

Packungsbeilage

Gebrauchsinformation

Gebrauchsinformation: Information für Anwender

LAMISIL ONCE 1 % , Lösung zur Anwendung auf der Haut

Terbinafin

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

Anwendung dieses Arzneimittels beginnen, denn sie enthält wichtige Informationen

für Sie.

Wenden Sie dieses Arzneimittel immer genau wie in dieser Packungsbeilage beschrieben

bzw. genau nach Anweisung Ihres Arztes oder Apothekers an.

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

Fragen Sie Ihren Arzt oder 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 Packunsbeilage angegeben sind.

Siehe Abschnitt 4.

Wenn Sie sich nach 7 Tagen nicht besser oder gar schlechter fühlen, wenden Sie sich an

Ihren Arzt.

Was in dieser Packungsbeilage steht:

Was ist LAMISIL ONCE 1% und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von LAMISIL ONCE 1% beachten?

Wie ist LAMISIL ONCE 1% anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist LAMISIL ONCE 1% aufzubewahren?

Inhalt der Packung und weitere Informationen

1. WAS IST LAMISIL ONCE 1% UND WOFÜR WIRD ES ANGEWENDET?

Lamisil Once behandelt Tinea pedis (Fußpilzerkrankung) mit einer einzigen Anwendung.

Lamisil Once wirkt, indem es den Pilz, der die Tinea pedis (Fußpilzerkrankung) verursacht,

abtötet. Nach der Anwendung auf den Füßen bleibt ein dünner farbloser Film auf der Haut

zurück. Der Film gibt den arzneilich wirksamen Bestandteil an die Haut ab.

Woran Sie erkennen können, dass Sie eine Tinea pedis (Fußpilzerkrankung) haben?

Tinea pedis (Fußpilzerkrankung) kommt nur an den Füßen vor. Sie beginnt oft zwischen den

Zehen, kann sich jedoch auch auf die Fußsohlen und Fußränder ausbreiten.

Die häufigste Form von Tinea pedis (Fußpilzerkrankung) verursacht Risse oder

Schuppungen der Haut. Möglich ist aber auch das Auftreten von leichten Schwellungen,

Bläschen oder nässenden Hautwunden. Dies kann oft mit dem Auftreten von Juckreiz oder

einem brennenden Gefühl verbunden sein.

Wenn Sie sich nicht sicher sind, ob die bei Ihnen bestehenden Symptome wirklich

durch Tinea pedis (Fußpilzerkrankung) hervorgerufen werden, sprechen Sie bitte mit

Ihrem Arzt oder Apotheker, bevor Sie Lamisil Once anwenden.

Gebrauchsinformation

2. WAS SOLLTEN SIE VOR DER ANWENDUNG VON LAMISIL ONCE 1% BEACHTEN?

Lamisil Once darf nicht angewendet werden,

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

Bestandteile dieses Arzneimittels sind.

Informieren Sie Ihren Arzt oder Apotheker, wenn dies auf Sie zutrifft, und verwenden Sie

keine Lamisil Once.

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Lamisil Once anwenden

wenn Sie an einer langandauernden Pilzinfektion der Fußsohlen und Fersen mit

verdickter und/oder stark schuppender Haut leiden, sollten Sie dieses Arzneimittel

nicht anwenden. Falls Sie glauben, dass diese Erkrankung bei Ihnen vorliegt, sollten Sie

Ihren Arzt aufsuchen, da Sie möglicherweise ein anderes Arzneimittel benötigen.

Nur zur äußerlichen Anwendung. Verwenden Sie es nicht in den Mund und schlucken Sie

sie nicht.

Vermeiden Sie den Kontakt der Lösung mit dem Gesicht, Augen oder geschädigter Haut.

Das Produkt enthält Alkohol und könnte zu Irritation führen (nach Einwirkung von

Sonnenstrahlen oder schwere Abschuppung der Haut)

Im Falle eines versehentlichen Kontaktes mit den Augen gründlich mit fließendem

Wasser spülen. Falls die Beschwerden anhalten, sollten Sie Ihren Arzt aufsuchen.

Lamisil Once enthält Alkohol. Von offenen Flammen fernhalten.

Arzneimittel für Kinder unzugänglich aufbewahren

Kinder und Jugendliche

Kinder und Jugendliche unter 18 Jahren sollten dieses Arzneimittel nicht anwenden.

Anwendung von Lamisil Once zusammen mit anderen Arzneimitteln

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

andere Arzneimittel angewendet haben oder beabsichtigen andere Arzneimittel anzuwenden

Während der Behandlung mit Lamisil Once dürfen Sie am Fuß keine anderen Arzneimittel

anwenden (einschließlich nicht verschreibungspflichtige Arzneimittel).

Schwangerschaft, Stillzeit

und Fortpflanzungsfähigkeit

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.

Lamisil Once sollte während der Schwangerschaft nur angewendet werden, wenn dies

unbedingt erforderlich ist.

Verwenden Sie Lamisil Once nicht während der Stillzeit.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Lamisil Once hat keinen Einfluss auf die Verkehrstüchtigkeit und die Fähigkeit zum

Bedienen von Maschinen.

3. WIE IST LAMISIL ONCE 1% ANZUWENDEN?

Wenden Sie dieses Arzneimittel immer genau nach Absprache mit Ihrem Arzt oder Apotheker

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

nl-NL

Gebrauchsinformation

Die empfohlene Dosis

beträgt: einmal Aufbringen der Lösung wie unten beschrieben.

Anweisungen zur Verwendung:

Erwachsene

Vorzugsweise wird Lamisil Once nach einer Dusche oder einem Bad aufgetragen.

Wenden Sie Lamisil Once nur einmal an.

Waschen Sie beide Füße und trocknen Sie diese sorgfältig ab.

Waschen Sie Ihre Hände und trocknen Sie diese ab.

Entfernen Sie den Verschluss von der Tube.

Tragen Sie das Arzneimittel auf beide Füße auf. Verwenden Sie für jeden Fuß ungefähr

die halbe Tubenmenge, soweit diese notwendig ist um die Haut zu bedecken. Beenden

Sie die Behandlung des ersten Fußes bevor sie den zweiten Fuß behandeln.

Tragen Sie das Arzneimittel wie unten dargestellt mit den Fingern auf jeden Fuß auf.

Verteilen Sie es gleichmäßig auf der Haut zwischen, unter und auf allen Zehen. Danach

auf der Sohle und dem Fußrand auftragen.

Reiben oder massieren Sie Lamisil Once nicht ein.

Behandeln Sie jeden Fuß in gleicher Weise, auch wenn die Haut gesund aussieht.

Dadurch wird sichergestellt, dass Sie den Pilz vollständig beseitigen – der Pilz könnte

sich auf dem anderen Fuß befinden, auch wenn es keine sichtbaren Anzeichen dafür

gibt.

Lassen Sie die Lösing 1–2 Minuten zu einem Film trocknen, bevor Sie Ihre Socken und

Schuhe anziehen.

Waschen Sie Ihre Hände nach der Anwendung mit warmen Wasser und Seife.

Nach der Anwendung von Lamisil Once sollten Sie Ihre Füße 24 Stunden nicht waschen

oder befeuchten. Nach vorsichtigem Waschen sollten die Füße sanft trocken getupft

werden.

Tragen Sie das Präparat kein zweites Mal auf.

Wie lange und wie oft sollten Sie Lamisil Once anwenden?

Wenden Sie nur einmal an. Keine zweite Mal verwenden.

Lamisil Once beginnt umgehend den Pilz abzutöten. Der gebildete Film bewirkt, dass der

Wirkstoff in Ihre Haut eindringt, wo er für mehrere Tage wirksam bleibt.

Ihr Hautzustand sollte sich nach wenigen Tagen verbessern, es kann jedoch bis zu 4

Wochen dauern, bis Ihre Haut vollständig abgeheilt ist.

Sollten Sie innerhalb von 1 Woche nach Anwendung von Lamisil Once keine

Anzeichen einer Besserung beobachten, lassen Sie sich bitte von Ihrem Arzt oder

Apotheker beraten.

Verwenden Sie das Arzneimittel kein zweites Mal im Rahmen der aktuellen

Fußpilzerkrankung, wenn das Arzneimittel bei Ihnen nach der ersten Anwendung keine

Wirkung zeigte.

Gebrauchsinformation

Lamisil Once ist an beiden Füßen anzuwenden, auch wenn nur auf einem Fuß sichtbare

Anzeichen des Fußpilzes sind. Dies stellt sicher, dass der Pilz vollständig beseitigt wird: Der

Pilz könnte auf anderen Fußpartien vorhanden sein, auch wenn es keine sichtbaren

Anzeichen gibt.

Nach Anwendung auf den Füßen trocknet das Arzneimittel schnell und bildet einen farblosen

Film.

Die Tube enthält eine ausreichende Arzneimittelmenge, um beide Füße zu behandeln.

Lamisil Once gibt den Wirkstoff in die Haut ab, wo dieser für einige Tage verbleibt, um den

Pilz abzutöten, der die Fußpilzerkrankung hervorruft. Um den bestmöglichen

Behandlungserfolg zu erzielen, sollten Sie die Füße nach Anwendung 24 Stunden lang nicht

waschen oder befeuchten.

Was können Sie unterstützend tun?

Halten Sie die betroffenen Bereiche nach den ersten 24 Stunden (nach Behandlungsbeginn)

durch regelmäßiges Waschen sauber. Trocknen Sie die Haut ohne zu reiben sorgfältig ab.

Versuchen Sie, auch wenn es jucken sollte, nicht zu kratzen, da dies zusätzliche

Verletzungen verursachen und den Heilungsprozess verlangsamen könnte bzw. die

Ausbreitung der Infektion fördern könnte.

Benutzen Sie Ihr eigenes Handtuch und tragen Sie Ihre eigene Kleidung, ohne sie mit

anderen Personen zu teilen, da eine Fußpilzerkrankung leicht übertragbar ist. Um sich vor

erneuten Infektionen zu schützen, sollten Sie Handtücher und Kleidung häufig waschen.

Was ist bei einem versehentlichen Verschlucken des Arzneimittels zu tun?

Informieren Sie Ihren Arzt. Er wird Ihnen mitteilen, was zu tun ist. Auch der Menge an Alkohol

im Produkt sollte berücksichtigt werden.

Wenn Sie eine gröβere Menge von Lamisil Once angewendet oder eingenommen haben,

kontaktieren Sie sofort Ihren Arzt, Apotheker oder das Antigiftzentrum (070/245.245).

Was ist bei einem versehentlichen Kontakt des Arzneimittels mit dem Gesicht oder

den Augen zu tun?

Waschen Sie Ihr Gesicht bzw. spülen Sie Ihre Augen sorgfältig mit fließendem Wasser.

Suchen Sie Ihren Arzt auf, wenn bei Ihnen weiterhin Beschwerden bestehen.

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.

Menschen können allergisch sind auf Lamisil Once. Dies manifestiert sich als Schwellungen

und Schmerzen, Hautausschlag oder Nesselsucht. Dies wurde sehr selten berichtet (kann in

1 in 10 000 Anwendern auftreten).

Falls eine allergischen Reaktion auftritt oder bei Auftreten eines der oben genannten

Symptome während der Anwendung dieses Arzneimittels, entfernen Sie den Film mit Alkohol

(Alkohol zur Desinfektion; in Apotheken erhältlich), waschen Sie Ihre Füße mit warmen Wasser

und Seife, spülen und trocknen Sie Ihre Füße ab und informieren Sie Ihren Arzt oder

Apotheker.

Gebrauchsinformation

Folgende Nebenwirkungen wurden ebenfalls berichtet:

Gelegentliche Nebenwirkungen (kann in 1 in 100 Anwendern auftreten)

Nebenwirkungen am Auftragungsort, wie Hauttrockenheit, Hautreizungen oder ein

brennendes Gefühl. Normaler Weise sind diese schwach ausgeprägt, vorübergehend und

harmlos.

Meldung von Nebenwirkungen.

Wenn Sie Nebenwirkungen bemerken, wenden Sie sich an Ihren Arzt, Apotheker oder das

medizinische Fachpersonal. Dies gilt auch für Nebenwirkungen, die nicht in dieser

Packungsbeilage angegeben sind. Sie können Nebenwirkungen auch direkt anzeigen über:

Für Belgien

Für Luxemburg

Föderalagentur für Arzneimittel und

Gesundheitsprodukte

Abteilung Vigilanz

EUROSTATION II

Victor Hortaplein 40/40

B-1060 Brüssel

Website: www.fagg.be

E-Mail: patientinfo@fagg-afmps.be

Direction de la Santé – Division de la

Pharmacie et des Médicaments

Villa Louvigny – Allée Marconi

L-2120 Luxembourg

Website:

http://www.ms.public.lu/fr/activites/pharmacie-

medicament/index.html

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

über die Sicherheit dieses Arzneimittels zur Verfügung gestellt werden.

5. WIE IST LAMISIL ONCE 1% AUFZUBEWAHREN?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Sie dürfen dieses Arzneimittel nach dem auf der Tube und dem Umkarton nach EXP

angegebenen Verfallsdatum nicht mehr verwenden. Das Verfalldatum bezieht sich auf

den letzten Tag des angegebenen Monats.

In der Originalverpackung aufbewahren, um den Inhalt vor Licht zu schützen. Nicht über

30 °C lagern.

Entsorgen Sie Arzneimittel nicht im 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 Lamisil Once enthält

Der Wirkstoff ist Terbinafin (als Hydrochlorid). Jedes Gramm der Lösung zur Anwendung auf

der Haut enthält 10 mg Terbinafin (als Hydrochlorid).

Die sonstigen Bestandteile sind Acrylat/Octylacrylamid Copolymer, Hydroxypropylcellulose,

mittelkettige Triglyzeride und Ethanol.

Wie Lamisil Once aussieht und Inhalt der Packung

Lamisil Once ist eine klare bis leicht trübe, gelartige Lösung. Es ist in einer Tube zu 4 g

Lösung erhältlich.

Pharmazeutischer Unternehmer

GlaxoSmithKline Consumer Healthcare s.a./n.v.

Gebrauchsinformation

Site Apollo

Avenue Pascal, 2-4-6

B-1300 Wavre

Hersteller

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road,

Brentford, Middlesex TW8 9GS,

Vereinigtes Königreich

Novartis Consumer Health, Gebro GmbH, Bahnhofbichl 13, 6391 Fieberbrunn, Österreich

Novartis Healthcare A/S, Lyngbyvey 172, 2100 Kobenhaven, Dänemark

Novartis Finland Oy, Metsänneidonkuja 10, 02130 Espoo, Finnland

Novartis Consumer Health GmbH, Zielstattstrasse 40, 81379 München, Deutschland

Novartis (Hellas) S.A.C.I., National Road No1 (12th km), Metamorphosi 144 51 Athens,

Griechenland

Novartis s.r.o., Na Pankráci 1724/129, 140 00 Praha 4, Tschechische Republik

Novartis Norge AS, Pb. 4284 Nydalen, 0401 Oslo, Norwegen

Novartis Sverige AB, Kemsivägen 1, 183 11 Täby, Schweden

Novartis Santé Familiale S.A.S., 10 rue Louis Blériot, 92500 Rueil-Malmaison, Frankreich

Novartis Consumer Health NV, Medialaan 40, B-1800 Vilvoorde, Belgien

Art der Abgabe

Apothekenpflichtig

Zulassungsnummer

BE291322

Diese Packungsbeilage wurde zuletzt genehmigt im 05/2016.

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Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Sargassum seaweed: limit the exposure of residents and workers to hydrogen sulphide

Since August 2014, the French Caribbean and French Guiana have been experiencing successive waves of Sargassum seaweed washing up on their coastlines. Despite the efforts made to clean it up, the seaweed decomposes in situ. This leads to the production of hydrogen sulphide (H2S), which can sometimes be detected at high concentrations. Doctors' reports concerning the health effects suffered by people exposed to H2S, and complaints from the general public relating to the problem of odours, have increased s...

France - Agence Nationale du Médicament Vétérinaire

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

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

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

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

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

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

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

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

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Brexit: Two-year implementation period for name and address changes

Brexit: Two-year implementation period for name and address changes

During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).

Danish Medicines Agency

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

16-10-2018

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

Fat Burners Zone Issues Voluntary Nationwide Recall of Zero Xtreme Due to Presence of Undeclared Sibutramine

Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme, capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market due to safety concerns. The presence of Sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

FDA - U.S. Food and Drug Administration

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

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

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

Published on: Wed, 03 Oct 2018 00:00:00 +0200 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 Ireland for the pesticide active substance ethoprophos 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 ethopro...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Avian influenza overview May – August 2018

Avian influenza overview May – August 2018

Published on: Thu, 27 Sep 2018 00:00:00 +0200 Between 16 May and 15 August 2018, three highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments and three HPAI A(H5N6) outbreaks in wild birds were reported in Europe. Three low pathogenic avian influenza (LPAI) outbreaks were reported in three Member States. Few HPAI and LPAI bird cases have been detected in this period of the year, in accordance with the seasonal expected pattern of LPAI and HPAI. There is no evidence to date ...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

Synthetic pitches: the expert assessments currently available conclude that the risks to health are negligible

In recent years, the increasing use of tyre granulates for sports pitches and playgrounds has raised concerns about their potential impact on health and the environment. ANSES has analysed the studies and expert assessments currently available on this topic and reports the main findings regarding the potential risks associated with the use or installation of synthetic pitches. The existing studies conclude that the health risks are of little concern, but point to potential risks to the environment.

France - Agence Nationale du Médicament Vétérinaire

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin 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 b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

FDA - U.S. Food and Drug Administration

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin 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...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin 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 cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Risk to human and animal health related to the presence of 4,15‐diacetoxyscirpenol in food and feed

Published on: Thu, 16 Aug 2018 00:00:00 +0200 4,15‐Diacetoxyscirpenol (DAS) is a mycotoxin primarily produced by Fusarium fungi and occurring predominantly in cereal grains. As requested by the European Commission, the EFSA Panel on Contaminants in the Food Chain (CONTAM) assessed the risk of DAS to human and animal health related to its presence in food and feed. Very limited information was available on toxicity and on toxicokinetics in experimental and farm animals. Due to the limitations in the avai...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Protocol for the scientific opinion on the Tolerable Upper Intake Level of dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 In June 2016, EFSA received a mandate from the national food competent authorities of five European countries (Denmark, Finland, Iceland, Norway and Sweden) to provide a dietary reference value (DRV) for sugars, with particular attention to added sugars. A draft protocol was developed with the aim of defining as much as possible beforehand the strategy that will be applied for collecting data, appraising the relevant evidence, and analysing and integrating t...

Europe - EFSA - European Food Safety Authority Publications

21-10-2018

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.”  During this Breast Cancer Awareness month, I urge women to check the facts  https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://g

It’s concerning that many women who qualify for a mammogram don’t go for regular screening, in part due to common myths like mammograms “are painful” or “cause cancer.” During this Breast Cancer Awareness month, I urge women to check the facts https://go.usa.gov/xPnyD . pic.twitter.com/DGz5Xvquky

FDA - U.S. Food and Drug Administration

21-10-2018

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%, up from 84% in 1995.

FDA - U.S. Food and Drug Administration

12-9-2018

 Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.

Europe - EMA - European Medicines Agency