Pre-Par

Hauptinformation

  • Handelsname:
  • Pre-Par Injektionslösung 50 mg-5 ml
  • Dosierung:
  • 50 mg-5 ml
  • Darreichungsform:
  • Injektionslösung
  • 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:
  • Pre-Par Injektionslösung 50 mg-5 ml
    Belgien
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Therapiegruppe:
  • Sympathomimetika weeënremmend

Weitere Informationen

Status

  • Quelle:
  • AFMPS - Agence Fédérale des Médicaments et des Produits de Santé - Belgium
  • Zulassungsnummer:
  • BE072107
  • Letzte Änderung:
  • 12-04-2018

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

Version 3.0, 04/2013

PACKUNGSBEILAGE

Gebrauchsinformation: Information für Anwender

PRE-PAR 50 mg/5 ml Injektionslösung

Ritodrin-Hydrochlorid

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

Arzneimittels beginnen, denn sie enthält wichtige Informationen.

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

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

-

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

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

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

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

Was in dieser Packungsbeilage steht

Was ist Pre-Par und wofür wird es angewendet?

Was sollten Sie vor der Anwendung von Pre-Par beachten?

Wie ist Pre-Par anzuwenden?

Welche Nebenwirkungen sind möglich?

Wie ist Pre-Par aufzubewahren?

Inhalt der Packung und weitere Informationen

1.

Was ist Pre-Par und wofür wird es angewendet?

Mittel, das die Gebärmutter entspannt.

Pre-Par wird bei Frauen angewendet, deren Wehentätigkeit zwischen der 22. und 37.

Schwangerschaftswoche unerwartet früh eingesetzt hat (vorzeitige Wehen), um die frühzeitige

Entbindung des Kindes kurzzeitig zu verzögern. Pre-Par wird höchstens 48 Stunden lang angewendet.

Hierdurch gewinnt Ihr Arzt oder Ihre Hebamme Zeit, um zusätzliche Maßnahmen zu ergreifen, die für

den Gesundheitszustand Ihres Kindes förderlich sind

2.

Was sollten Sie vor der Anwendung von Pre-Par beachten?

Pre-Par darf nicht angewendet werden,

wenn Sie sich noch nicht in der 22. Schwangerschaftswoche befinden

wenn Sie unter einer ischämischen Herzkrankheit leiden (einer Erkrankung, die durch eine

verminderte Blutzufuhr zum Herzmuskel gekennzeichnet ist, was Symptome wie Brustschmerzen

(Angina pectoris) auslösen kann) oder bei Ihnen ein Risiko für die Entwicklung dieser Krankheit

festgestellt wurde

wenn Sie schon einmal eine Fehlgeburt im ersten oder zweiten Schwangerschaftsdrittel erlitten

haben

wenn Sie schwanger sind und bei Ihnen oder Ihrem Kind bestimmte Faktoren vorliegen, bei

denen eine Verlängerung der Schwangerschaft riskant wäre (z. B. starker Bluthochdruck,

Infektion der Gebärmutter, Blutungen, Verlegung des Geburtskanals durch die Plazenta, Ablösung

der Plazenta oder Versterben des Kindes in der Gebärmutter)

wenn Sie an Herz-Kreislauf-Erkrankungen mit Herzklopfen (z. B. Herzklappenfehler) oder an

einer langjährigen Lungenerkrankung (z. B. chronische Bronchitis, Emphysem), die einen Anstieg

des Blutdrucks im Lungenkreislauf (pulmonale Hypertonie) zur Folge hat, leiden

wenn Sie allergisch gegen Ritodrin-Hydrochlorid oder einen der in Abschnitt 6. genannten

sonstigen Bestandteile dieses Arzneimittels sind.

im Falle von Herzkrankheit der Mutter.

bei retroplazentarem Hämatom

bei arterieller Hypertonie mit diastolischem Blutdruck > 90 mm Hg

bei jeder Form einer Überfunktion der Schilddrüse der Mutter

bei einer vermutlichen oder nachgewiesenen Chorioamnionitis

bei einem fötalen Leiden außer im Rahmen einer Hypertonizität der Gebärmutter

Warnhinweise und Vorsichtsmaßnahmen

Bitte sprechen Sie mit Ihrem Arzt oder dem medizinischen Fachpersonal, bevor Sie eine Infusion mit

Pre-Par erhalten, wenn:

während der Schwangerschaft Probleme aufgetreten sind

Ihre Fruchtblase während der Schwangerschaft geplatzt ist

Sie zu viel Flüssigkeit in der Lunge haben, was Atemnot verursacht (Lungenödem)

Sie an Bluthochdruck leiden

Sie Diabetikerin sind. In diesem Fall müssen bei Ihnen zusätzliche Blutzuckertests durchgeführt

werden, wenn Sie <Handelsname> erhalten.

bei Ihnen eine Überfunktion der Schilddrüse vorliegt

in Ihrer Vorgeschichte Herz-Kreislauf-Erkrankungen mit Atemnot, Herzklopfen oder Angina

pectoris aufgetreten sind (siehe Pre-Par darf nicht angewendet werden,).

Die Behandlung einer drohenden Frühgeburt mit einem Tocolyticum ist nach der 37.

Schwangerschaftswoche nicht mehr angewiesen.

Die Behandlung im Rahmen eines frühzeitigen Blasensprungs ist bei Abwesenheit von

Gebärmutterkontraktionen oder bei Verdacht auf Chorioamnionitis nicht angewiesen.

Wenn Sie an Diabetes oder an Asthma leiden, fragen Sie bitte Ihren Arzt oder Apotheker um Rat,

bevor Sie Pre-Par einnehmen/verabreicht bekommen. Im Fall von Diabetes müssen Sie regelmäßig

von Ihrem Arzt kontrolliert werden (Kontrolle des Blutzuckerspiegels).

Jede Patientin, bei der ein Herzleiden vermutet wird, muss sehr gewissenhaft beobachtet werden. Eine

asymptomatische Herzerkrankung kann sich durch die Verwendung von Ritodrin manifestieren.

Der Arzt wird Ihr Herz und Ihr ungeborenes Kind überwachen. Der Arzt wird unter Umständen auch

Bluttests durchführen, um Veränderungen Ihrer Blutwerte festzustellen (siehe Abschnitt 3).

Pre-Par darf ausschließlich unter gewissenhafter ärztlicher Beaufsichtigung verabreicht werden

Bitte sprechen Sie mit Ihrem Arzt oder Apotheker, bevor Sie Pre-Par einnehmen.

Kinder

Nicht zutreffend.

Einnahme von Pre-Par zusammen mit anderen Arzneimitteln

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

Arzneimittel einnehmen, kürzlich andere Arzneimittel eingenommen haben oder beabsichtigen,

andere Arzneimittel einzunehmen, einschließlich nicht verschreibungspflichtiger Arzneimittel. Hierzu

zählen auch pflanzliche Arzneimittel. <Handelsname> kann die Wirkungsweise einiger Arzneimittel

beeinflussen, und einige Arzneimittel können die Wirkungsweise von <Handelsname> beeinflussen.

Informieren Sie Ihren Arzt, das medizinische Fachpersonal oder Ihren Apotheker insbesondere dann,

wenn Sie Folgendes einnehmen:

Arzneimittel gegen unregelmäßigen oder schnellen Herzschlag (z. B. Digoxin)

andere Betablocker (z. B. Atenolol oder Propranolol), einschließlich Augentropfen (z. B. Timolol)

Xanthine (z. B. Theophyllin oder Aminophyllin)

Steroide (z. B. Prednisolon)

Entwässerungstabletten, auch bekannt als Diuretika (z. B. Furosemid)

Arzneimittel gegen Diabetes zur Senkung des Blutzuckerspiegels (z. B. Insulin, Metformin,

Glibenclamid).

Wenn eine Senkung des Serumkaliums auftritt, muss eine gleichzeitige Verabreichung von Digoxin

oder Kalium-verlierenden Diuretika vermieden werden.

Die in der Chirurgie verwenden Anästhetika können den Blutdruck senkenden Effekt von Ritodrin

verstärken und in Ausnahmefällen eine Herzrhythmusstörung in eine ernstigere ventrikuläre

Tachykardie umwandeln.

Wenn bei Ihnen ein chirurgischer Eingriff in Vollnarkose geplant ist, wird Ihr Arzt die Anwendung

von Pre-Par nach Möglichkeit 6 Stunden vor der Operation absetzen, um Nebenwirkungen (wie

unregelmäßigen Herzschlag oder Blutungen der Gebärmutter) zu verhindern.

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

Arzneimittel eingenommen haben oder beabsichtigen andere Arzneimittel einzunehmen.

Einnahme von Pre-Par zusammen mit Nahrungsmitteln und Getränken

Nicht zutreffend.

Schwangerschaft und Stillzeit

Untersuchungen am Tier ergaben - selbst bei hoher Dosierung - keine teratogenen Wirkungen (= die

Fehlbildungen beim Fetus hervorrufen).

Pre-Par ist in den ersten 20 Wochen der Schwangerschaft nicht angezeigt. Es wurde nachgewiesen,

daß Ritodrin die Plazentaschranke passiert. Daher ist es angeraten, das Neugeborene sehr sorgfältig

auf mögliche Nebenwirkungen von Ritodrin zu überwachen.

Fragen Sie vor der Einnahme von allen Arzneimitteln Ihren Arzt oder Apotheker um Rat.

Verkehrstüchtigkeit und Fähigkeit zum Bedienen von Maschinen

Nicht zutreffend.

Pre-Par enthält sonstigen Bestandteile

Pre-Par Ampullen enthalten Natriummetabisulphit, was in seltenen Fällen schwerwiegende

Überempfindlichkeitsreaktionen und Bronchospasmus verursachen kann.

3.

Wie ist Pre-Par anzuwenden?

Sie werden niemals gebeten, das Arzneimittel selbst anzuwenden. Sie erhalten das Arzneimittel

immer von einer entsprechend qualifizierten Person nach sorgfältiger Abwägung der Vorteile von Pre-

Par für Ihr Kind und der möglichen unerwünschten Wirkungen der Behandlung für Sie.

Zur vorübergehenden Verzögerung einer vorzeitigen Wehentätigkeit

Sie erhalten Pre-Par durch einen Arzt, bei dem entsprechende medizinische

Versorgungsmöglichkeiten vorhanden sind, um eine kontinuierliche Überwachung Ihres eigenen und

des Gesundheitszustandes Ihres Kindes während der Anwendung zu gewährleisten.

Folgende Maßnahmen werden bei Bedarf ergriffen:

Blutdruck und Herzfrequenz. Ihr Arzt wird eine Senkung der Dosis oder das Absetzen von

Pre-Par in Betracht ziehen, wenn Ihre Herzfrequenz 120 Schläge/Minute überschreitet.

Elektrokardiografie (EKG, elektrische Aktivität des Herzens). Informieren Sie Ihren Arzt

unverzüglich, wenn bei Ihnen während der Behandlung Schmerzen in der Brust auftreten.

Wenn das EKG Veränderungen zeigt und Sie Schmerzen in der Brust haben, wird der Arzt die

Anwendung von Pre-Par beenden.

Wasser- und Salzbilanz im Körper. Informieren Sie Ihren Arzt unverzüglich, wenn bei Ihnen

während der Behandlung Husten oder Atemnot auftreten. Wenn es Anzeichen dafür gibt, das

sich Wasser in Ihrer Lunge ansammelt (sogenanntes Lungenödem) (z. B. Husten oder Atemnot),

kann der Arzt die Anwendung von Pre-Par beenden.

Blutzuckerspiegel und Abfall des pH-Werts im Körper zusammen mit einem Anstieg von

Milchsäure im Blut (so genannte Laktatazidose)

Kaliumspiegel des Blutes (ein niedriger Kaliumspiegel kann mit einem Risiko für

unregelmäßigen Herzschlag einhergehen)

Die intravenöse Behandlung muss nach Möglichkeit mit einer elektromechanischen Pumpe

eingeleitet werden. Von der Infusion wird höchstens 1 Liter pro 24 Stunden verabreicht.

Wenn Sie eine größere Menge von Pre-Par eingenommen haben, als Sie sollten

Im Falle einer Überdosierung treten folgende Symptome auf : Übelkeit, Erbrechen, Zittern, Erhöhung

des Pulsschlags, Kurzatmigkeit.

Wenn Sie eine größere Menge von Pre-Par haben angewendet, kontaktieren Sie sofort Ihren Arzt,

Ihren Apotheker oder das Antigiftzentrum (070/245.245).

Wenn Sie die Einnahme von Pre-Par vergessen haben

Nicht zutreffend.

Wenn Sie die Einnahme von Pre-Par abbrechen

Nicht zutreffend.

Wenn Sie weitere Fragen zur Einnahme 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.

Wesentliche Nebenwirkungen, die bei der Behandlung vorzeitiger Wehentätigkeit auftreten

können:

Selten (kann bis zu 1 von 1.000 Behandelten betreffen)

Brustschmerzen (aufgrund von Herzproblemen wie Angina). Wenn Sie dies bemerken, informieren

Sie Ihren Arzt oder das medizinische Fachpersonal unverzüglich.

Folgende Nebenwirkungen wurden ebenfalls bei allen Beta-Agonisten wie <Handelsname> bei der

Anwendung zur Verzögerung von vorzeitiger Wehentätigkeit beobachtet:

Sehr häufig (kann mehr als 1 von 10 Behandelten betreffen)

Schneller Herzschlag

Häufig (kann bis zu 1 von 10 Behandelten betreffen)

Herzklopfen (Palpitationen)

niedriger Blutdruck, der Benommenheit oder Schwindelgefühl verursachen kann

niedriger Kaliumspiegel im Blut, wodurch es zu Muskelschwäche, Durst- oder Kribbelgefühl

kommen kann

Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen)

Ansammlung von Flüssigkeit in der Lunge (Lungenödem), die zu Atemproblemen führen kann

oder.

Selten (kann bis zu 1 von 1.000 Behandelten betreffen)

untypischer oder unregelmäßiger Herzschlag

hohe Konzentrationen an Blutzucker (Glukose) und/oder Milchsäure im Blut

Flush (Errötung) des Gesichts und Hals

Bei der Mutter

Herzinfarkt wurde äußerst selten gemeldet. Abhängig von der Dosierung werden bei einigen

Patientinnen ein beklemmendes Gefühl, Zittern, Schwitzen, Übelkeit, Erbrechen, Erregung,

Schüttelfrost, Fieber und Kopfschmerzen festgestellt. Angstgefühl, Juckreiz, Abweichungen des

Blutbilds, Rhabdomyolyse (Abbau von Muskelgewebe, einhergehend mit Muskelkrämpfen, Fieber

und einer rotbraunen Verfärbung des Harns), Erhöhung der Leberenzyme und schwerwiegende

Überempfindlichkeitsreaktionen wurden ebenso gemeldet. Diese unerwünschten Nebenwirkungen

sind nach Einstellung der Behandlung reversibel.

Eine vorübergehende Erhöhung des Blutzuckerspiegels tritt bereits rasch nach der Einleitung der

Behandlung auf, und verschwindet nach einigen Stunden oder spätestens nach 3 Tagen, selbst wenn

Pre-Par weiter verabreicht wird. Die Erhöhung der Insulinwerte ist vorübergehender Art. Der Glucose-

Toleranztest (GTT) ist vorübergehend gestört.

Warnen Sie Ihren Arzt, bevor Sie mit der Behandlung beginnen:

- wenn Sie an einer Herzkrankheit, unregelmäßigem Herzschlag oder Angina pectoris gelitten haben

oder leiden. Obwohl die Häufigkeit nicht genau bekannt ist, können bestimmte Personen Schmerzen

im Brustbereich erfahren (aufgrund von Herzproblemen, wie beispielsweise Angina Pectoris). Warnen

Sie Ihren Arzt / Ihre Hebamme, falls Sie diese Symptome spüren, während Sie mit Pre-Par behandelt

werden, aber stoppen Sie die Einnahme des Arzneimittels nicht, bevor Ihnen dies vom Arzt

angeordnet wird.

Bei dem Fötus oder dem Neugeborene

Zunahme der fötalen Herzfrequenz um 5 bis 30 Schläge pro Minute, ohne klinische Bedeutung.

Eine vorübergehende fötale Erhöhung des Blutzuckerspiegels und der Insulinwerte kann vorkommen.

Meldung von Nebenwirkungen

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

für Nebenwirkungen, die nicht in dieser Packungsbeilage angegeben sind.

Sie können Nebenwirkungen auch direkt über website: www.fagg-afmps.be oder e-mail:

patientinfo@fagg-afmps.be anzeigen. Indem Sie Nebenwirkungen melden, können Sie dazu

beitragen, dass mehr Informationen über die Sicherheit dieses Arzneimittels zur Verfügung gestellt

werden.

5.

Wie ist Pre-Par aufzubewahren?

Bewahren Sie dieses Arzneimittel für Kinder unzugänglich auf.

Nicht über 25°C lagern.

Sie dürfen dieses Arzneimittel nach dem auf dem Umkarton nach „EXP“ angegebenen Verfalldatum

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

Sie dürfen Pre-Par Injektionslösung nicht verwenden, wenn Sie Folgendes bemerken: die Lösung ist

farbig oder enthält eine Niederlage.

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

Verschreibungspflichtig.

Was Pre-Par enthält

Der Wirkstoff ist: Ritodrin-Hydrochlorid 50 mg/5 ml.

Die sonstigen Bestandteile sind: Essigsäure – Natriumhydroxid – Natriummetabisulfit –

Natriumchlorid – Wasser zur Injektion bis 1 ml.

Wie Pre-Par aussieht und Inhalt der Packung

Pre-Par ist als Packung mit 1, 6, 10 und 50 Ampullen mit 5 ml mit 50 mg Ritodrin-Hydrochlorid zur

intravenösen Verabreichung, erhältlich.

Pharmazeutischer Unternehmer und Hersteller

Pharmazeutischer Unternehmer

Eumedica N.V.

Winston Churchilllaan 67

BE-1180 Brussel

Hersteller

Laboratoires Thissen S.A.

Rue de la Papyrée 2-4

BE-1420 Braine-l’Alleud

Zulassungsnummer

BE072107

Diese Packungsbeilage wurde zuletzt genehmigt im 05/2014.

Stand der Information 02/2014

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Pest categorisation of Cronartium spp. (non‐EU)

Pest categorisation of Cronartium spp. (non‐EU)

Published on: Wed, 19 Dec 2018 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium spp. (non‐EU), a well‐defined and distinguishable group of fungal pathogens of the family Cronartiaceae. There are at least 40 species described within the Cronartium genus, of which two are considered native to the EU (C. gentianeum and C. pini) and one has been introduced in the 19th century (C. ribicola) and is now widespread in the EU – these t...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-12-2018

Giant Tiger recalls 6.5 foot Pre-Lit Noble Pine Tree

Giant Tiger recalls 6.5 foot Pre-Lit Noble Pine Tree

Some trees may have been sold with a 12V adaptor, not a 5V adaptor as intended. When the 12V adaptor is used it can cause the lights to overheat, posing a fire hazard.

Health Canada

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Statement on the safety of d‐ribose

Statement on the safety of d‐ribose

Published on: Thu, 13 Dec 2018 In 2018, the EFSA NDA Panel adopted the Scientific Opinion on the safety of d‐ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that d‐ribose is safe for the general population at intake levels up to 36 mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panel was aske...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Pest categorisation of Septoria malagutii

Pest categorisation of Septoria malagutii

Published on: Wed, 12 Dec 2018 The Panel on Plant Health performed a pest categorisation of Septoria malagutii, the causal agent of annular leaf spot of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. malagutii is present in Bolivia, Ecuador, Peru and Venezuela. The pest is not known to occur in the EU and is listed as Septoria lycopersici var. malagutii in Annex IAI of Directive 2000/29/EC, meaning its introduction into t...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Reporting Avian Influenza surveillance

Reporting Avian Influenza surveillance

Published on: Thu, 29 Nov 2018 Avian influenza viruses infect domestic poultry and wild birds as well as humans. In poultry, depending on whether these viruses are of high pathogenicity (HPAI) or low pathogenicity (LPAI), the infection can cause different clinical signs, with HPAI causing high mortality in poultry flocks. In order to ensure early detection of avian influenza viruses, surveillance in poultry and wild birds is considered essential. In 2010, the European Commission provided some guidelines...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Understanding ASF spread and emergency control concepts in wild boar populations using individual‐based modelling and spatio‐temporal surveillance data

Published on: Thu, 29 Nov 2018 African swine fever (ASF) infection is circulating in Eurasia since a decade within wild boar populations without a demonstrated vector host. Further the infection was recurrently translocated by spatio‐temporal dynamics that is incompatible with wild boar movement characteristics. Management actions are required in areas affected by ASF. Control measures address areas with recent focal introduction and areas with ASF circulating several seasons or endemic occurrence. In v...

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Hazard identification and ranking for poultry at slaughter

Hazard identification and ranking for poultry at slaughter

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

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

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

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

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

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

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

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

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 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 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

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

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

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

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

Contaminated valsartan has so far not caused an increased incidence of cancer cases in Denmark

A Danish registry study has examined if the cancer incidence rate is higher among people treated with the blood pressure lowering medicine Valsartan, which due to the risk of contamination was recalled from the market in July 2018. The study concludes that no increased cancer incidence can be seen at present.

Danish Medicines Agency

11-9-2018

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Use of the convection oven fan during pre-heating or broiling can cause accumulated gas to ignite, posing a burn hazard to consumers when oven door is opened.

Health Canada

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

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Identification and evaluation of potentially mutagenic and carcinogenic food contaminants

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Heat processing of food gives rise to a plethora of chemical compounds whose toxicological effects are largely unknown. Due to a general lack of experimental toxicological data, assessing the risks associated with the consumption of these substances remains a challenge. Computer models that allow for an in silico prediction of physicochemical and toxicological characteristics, may be able to fill current data gaps and facilitate the risk assessment of toxico...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Anthrax

Anthrax

Anthrax is a zoonosis (i.e. a disease common to humans and animals) that primarily affects herbivores. It is caused by Bacillus anthracis, a bacterium that is unusual in that it persists in soil for decades as spores. ANSES is the National Reference Laboratory for this disease. Here we provide a presentation of the disease and the role played by ANSES.

France - Agence Nationale du Médicament Vétérinaire

5-12-2018

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

TGA presentation: Webinar: Advertising therapeutic goods in 2019: The Code basics – 20 November

The slides from TGA's webinar on Advertising Code Basics have been published

Therapeutic Goods Administration - Australia

4-12-2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

TGA presentation: Advertising therapeutic goods in 2019: The Code basics, 13 and 15 November 2018

A detailed walkthrough of the Code with examples to illustrate the application of the key sections.

Therapeutic Goods Administration - Australia

29-11-2018

TGA presentation: Advertising Therapeutic Goods to consumers - Complaints handling

TGA presentation: Advertising Therapeutic Goods to consumers - Complaints handling

An overview of the TGA's new advertising complaints handling framework.

Therapeutic Goods Administration - Australia

9-11-2018

TGA presentation: Generic and Biosimilar Medicines Association (GBMA) meeting, 2 November 2018

TGA presentation: Generic and Biosimilar Medicines Association (GBMA) meeting, 2 November 2018

Short presentation on the ACSS Consortium, the Generic Medicines Working Group and the Generic Medicines Work-Sharing Trial

Therapeutic Goods Administration - Australia

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

10-9-2018

 Pre-authorisation guidance

Pre-authorisation guidance

Europe - EMA - European Medicines Agency