EQUEST orales Gel

Hauptinformation

  • Handelsname:
  • EQUEST orales Gel 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys
  • Einheiten im Paket:
  • 1 x 12,2 g, Laufzeit: 24 Monate,10 x 12,2 g, Laufzeit: 24 Monate
  • Verschreibungstyp:
  • Arzneimittel zur wiederholten Abgabe gegen aerztliche Verschreibung
  • Verwenden für:
  • Tiere
  • Art der Medizin:
  • allopathic Droge

Dokumenten

Lokalisierung

  • Erhältlich in:
  • EQUEST orales Gel 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys
    Österreich
  • Sprache:
  • Deutsch

Therapeutische Informationen

  • Produktbesonderheiten:
  • Abgabe durch eine (öffentliche) Apotheke; NE (Abgabemöglichkeit nicht eingeschränkt)

Weitere Informationen

Status

  • Quelle:
  • AGES
  • Zulassungsnummer:
  • 8-00375
  • Berechtigungsdatum:
  • 18-01-1999
  • Letzte Änderung:
  • 01-12-2018

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

Gebrauchsinformation

EQUEST orales Gel 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys

1.

NAME

UND

ANSCHRIFT

DES

ZULASSUNGSINHABERS

UND,

WENN

UNTERSCHIEDLICH,

DES

HERSTELLERS,

DER

FÜR

DIE

CHARGENFREIGABE VERANTWORTLICH IST

Zulassungsinhaber:

Zoetis Österreich GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Hersteller, der für die Chargenfreigabe verantwortlich ist:

Zoetis Manufacturing & Research Spain, S.L.

Ctra. Camprodón s/n "la Riba"

17813 Vall de Bianya

Girona

Spain

2.

BEZEICHNUNG DES TIERARZNEIMITTELS

EQUEST orales Gel 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys

3.

WIRKSTOFF(E) UND SONSTIGE BESTANDTEILE

Wirkstoff:

mg/g

Moxidectin

18,92

Sonstige Bestandteile:

Benzylalkohol

37,84

Natriumedetat

0,24

4.

ANWENDUNGSGEBIETE

Für Pferde und Ponys:

Das Tierarzneimittel ist zur Behandlung von Infektionen, die durch folgende Moxidectin-empfindliche

Stämme verursacht werden, indiziert:

Große Strongyliden:

- Strongylus vulgaris (adulte und arterielle Formen)

- Strongylus edentatus (adulte und viszerale Formen)

- Triodontophorus brevicauda (adulte Formen)

- Triodontophorus serratus (adulte Formen)

- Triodontophorus tenuicollis (adulte Formen)

Kleine Strongyliden (adulte Formen und larvale Darmlumenstadien):

- Cyathostomum spp.

- Cylicocyclus spp.

- Cylicostephanus spp.

- Cylicodontophorus spp.

- Gyalocephalus spp.

Spulwürmer:

- Parascaris equorum (adulte Formen und Larven)

Andere Arten:

- Oxyuris equi (adulte Formen und Larven)

- Habronema muscae (adulte Formen)

- Gasterophilus intestinalis (L

- Gasterophilus nasalis (L

- Strongyloides westeri (adulte Formen)

- Trichostrongylus axei

Das Tierarzneimittel besitzt eine über zwei Wochen anhaltende Wirkung gegen kleine Strongyliden. Die

Ausscheidung kleiner Strongyliden-Eier wird für 90 Tage unterdrückt.

Das Tierarzneimittel ist wirksam gegen intramucosale L

Formen (in der Entwicklungsphase) der kleinen

Strongyliden. Nach 8 Wochen nach Behandlung werden frühe (hybobiotische) L

Formen der kleinen

Strongyliden eliminiert.

5.

GEGENANZEIGEN

Nicht bei Fohlen, die jünger als 4 Monate sind, anwenden.

Nicht anwenden bei bekannter Überempfindlichkeit gegenüber dem Wirkstoff oder einem der sonstigen

Bestandteile.

6.

NEBENWIRKUNGEN

In sehr seltenen Fällen kann es bei jungen Tieren zu Ataxie, Abgeschlagenheit, abdominalen Schmerzen,

Krämpfen,

Schlaffheit

Unterlippe

Schwellung

Maules

kommen.

Diese

unerwünschten

Wirkungen sind normalerweise vorübergehend und verschwinden in den meisten Fällen von selbst.

Die Angaben zur Häufigkeit von Nebenwirkungen sind folgendermaßen definiert:

- Sehr häufig (mehr als 1 von 10 behandelten Tieren zeigen Nebenwirkungen)

- Häufig (mehr als 1 aber weniger als 10 von 100 behandelten Tieren)

- Gelegentlich (mehr als 1 aber weniger als 10 von 1000 behandelten Tieren)

- Selten (mehr als 1 aber weniger als 10 von 10.000 behandelten Tieren)

- Sehr selten (weniger als 1 von 10.000 behandelten Tieren, einschließlich Einzelfallberichte)

Falls Sie Nebenwirkungen, insbesondere solche, die nicht in der Packungsbeilage aufgeführt sind, bei

Ihrem Tier feststellen, oder falls Sie vermuten, dass das Tierarzneimittel nicht gewirkt hat, teilen Sie dies

bitte Ihrem Tierarzt oder Apotheker mit.

7.

ZIELTIERART(EN)

Pferde und Ponys

8.

DOSIERUNG FÜR JEDE TIERART, ART UND DAUER DER ANWENDUNG

Zur einmaligen Anwendung.

empfohlene

orale

Dosis

beträgt

Moxidectin/kg

Körpergewicht

unter

Verwendung

kalibrierten Applikationsspritze (eine (1) Unterteilung pro 25 kg Körpergewicht).

Halten

Spritze

Kappenende

nach

links

gerichtet

dass

Gewichtsmarkierungen und die kleinen schwarzen Markierungen sehen können. Jede kleine schwarze

Markierung bezieht sich auf 25 kg Körpergewicht.

Drehen Sie den grünen Anzeigering, bis die linke Seite des Ringes das Körpergewicht des Tieres markiert

hat.

Es wird empfohlen, eine Waage oder ein Gewichtsband zu benutzen, um eine genaue Dosierung zu

gewährleisten.

Eine einzelne Applikationsspritze ist ausreichend für ein 700 kg schweres Pferd.

9.

HINWEISE FÜR DIE RICHTIGE ANWENDUNG

Um Überdosierungen zu vermeiden, sollte besonders bei leichtgewichtigen Fohlen oder Ponyfohlen auf

eine genaue Dosierung geachtet werden.

Es darf nicht mehr als ein Tier mit derselben Applikationsspritze behandelt werden, es sei denn die Pferde

stehen zusammen oder auf demselben Hof in direktem Kontakt miteinander.

10.

WARTEZEIT(EN)

Pferde:

Essbare Gewebe: 32 Tage.

Milch: Nicht bei Stuten anwenden, deren Milch für den menschlichen Verzehr vorgesehen ist.

11.

BESONDERE LAGERUNGSHINWEISE

Arzneimittel unzugänglich für Kinder aufbewahren.

Haltbarkeit nach Öffnen des Behältnisses: 6 Monate

Nicht über 25°C lagern.

Sie dürfen das Tierarzneimittel nach dem auf dem Behältnis angegebenen Verfalldatum {Verwendbar bis}

nicht mehr anwenden.

12.

BESONDERE WARNHINWEISE

Besondere Vorsichtsmaßnahmen für die Anwendung bei Tieren:

Das Tierarzneimittel wurde speziell zur Anwendung beim Pferd entwickelt. Bei Hunden oder Katzen

können aufgrund der Moxidectin-Konzentration in diesem Produkt Nebenwirkungen auftreten, wenn sie

die Möglichkeit haben herausgelaufenes Gel aufzunehmen oder Zugang zu benutzten Applikationsspritzen

haben.

Neurologische

Symptome

(z.B.

Ataxie,

Muskelzittern

Krämpfe)

sowie

Störungen

Verdauungstraktes oder vermehrter Speichelfluss wurden beobachtet.

Besondere Vorsichtsmaßnahmen für den Anwender:

Direkter Kontakt mit Haut und Augen ist zu vermeiden.

Die Verwendung von Schutzhandschuhen wird empfohlen.

Nach Anwendung Hände oder andere ungeschützte Stellen waschen.

Während des Umgangs mit dem Tierarzneimittel nicht rauchen, trinken oder essen.

Im Falle eines Augenkontaktes ist das Auge mit reichlich klarem Wasser auszuspülen und ein Arzt

aufzusuchen.

Sonstige Vorsichtsmaßnahmen bezüglich der Auswirkungen auf die Umwelt:

Moxidectin erfüllt die Kriterien für einen (sehr) persistenten, bioakkumulierbaren und toxischen (PBT)

Stoff; daher muss die Exposition der Umwelt gegenüber Moxidectin so weit wie möglich beschränkt

werden. Behandlungen sind nur bei Notwendigkeit zu verabreichen und müssen auf der Anzahl der in den

Fäkalien festgestellten Parasiteneier oder auf einer Bewertung des Risikos eines Befalls auf Einzeltier-

und/oder Herdenebene basieren. Um die Emission von Moxidectin in Oberflächengewässer zu reduzieren

und basierend auf dem Ausscheidungsprofil von Moxidectin bei Verabreichung als Formulierung zum

Eingeben an Pferde sollten behandelte Tiere während der ersten Woche nach der Behandlung keinen

Zugang zu Wasserläufen haben.

andere

makrozyklische

Lactone

besitzt

Moxidectin

Potenzial,

Nicht-Zielorganismen,

insbesondere Wasserorganismen und Dungfauna, negativ zu beeinflussen:

Moxidectin enthaltende Fäkalien, die von behandelten Tieren auf die Weide ausgeschieden werden,

können die Abundanz von Organismen, die sich von Dung ernähren, temporär reduzieren. Nach einer

Behandlung von Pferden mit dem Tierarzneimittel können über einen Zeitraum von mehr als 1

Woche Moxidectin-Konzentrationen ausgeschieden werden, die potenziell toxisch für Dungkäfer und

Dungfliegen sind und die Abundanz der Dungfauna reduzieren können.

Moxidectin ist für Wasserorganismen, einschließlich Fische, inhärent toxisch. Das Tierarzneimittel

sollte ausschließlich entsprechend den Anweisungen auf dem Etikett angewendet werden.

Trächtigkeit und Laktation:

Das Tierarzneimittel hat sich als sicher in der Anwendung bei trächtigen und laktierenden Stuten

erwiesen.

Überdosierung (Symptome, Notfallmaßnahmen und Gegenmittel):

Unerwünschte

Reaktionen

können

Fohlen

nach

Verabreichung

zweifachen

Menge

empfohlenen Dosis und bei ausgewachsenen Pferden nach Verabreichung der dreifachen Menge der

empfohlenen Dosis auftreten. Die Symptome sind Abgeschlagenheit, Inappetenz, Ataxie und Schlaffheit

der Unterlippe 8 bis 24 Stunden nach der Behandlung. Die Symptome nach einer Überdosis Moxidectin

sind die Gleichen, die in sehr seltenen Fällen nach Verabreichung der empfohlenen Dosis auftreten.

Zusätzlich können Hypothermie und fehlender Appetit auftreten. Es gibt kein spezifisches Gegenmittel.

13.

BESONDERE VORSICHTSMASSNAHMEN F‹R DIE ENTSORGUNG VON

NICHT

VERWENDETEM ARZNEIMITTEL ODER VON

ABFALLMATERIALIEN,

SOFERN

ERFORDERLICH

Der Wirkstoff Moxidectin ist für Fische und andere im Wasser lebende Organismen giftig.

Wasserläufe dürfen nicht mit dem Tierarzneimittel oder leeren Behältern verunreinigt werden.

Arzneimittel sollten nicht über das Abwasser oder den Haushaltsabfall entsorgt werden. Fragen Sie Ihren

Tierarzt, wie nicht mehr benötigte Arzneimittel zu entsorgen sind. Diese Maßnahmen dienen dem

Umweltschutz.

14.

DATUM DER FASSUNG DER PACKUNGSBEILAGE

Dezember 2017

15.

WEITERE ANGABEN

HDPE (Hohe Dichte Polyethylen)-Spritze mit einem LDPE (Niedrige Dichte Polyethylen)-Kolben mit

Kalibrierung und Verschlusskappe, die 14,8 g Gel enthält.

Packungsgrößen:

Karton mit 1 Applikationsspritze.

Karton mit 10 Einzelpackungen (Applikationsspritzen).

Karton mit 20 Einzelpackungen (Applikationsspritzen).

Es werden möglicherweise nicht alle Packungsgrößen in Verkehr gebracht.

Z.-Nr.: 8-00375

Falls weitere Informationen über das Tierarzneimittel gewünscht werden, setzen Sie sich bitte mit dem

örtlichen Vertreter des Zulassungsinhabers in Verbindung.

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AMvB in consultatie voor inrichting wietteeltexperiment

AMvB in consultatie voor inrichting wietteeltexperiment

Minister Bruins voor Medische Zorg en minister Grapperhaus van Justitie en Veiligheid  hebben vandaag de concept algemene maatregel van bestuur (AMvB) voor de inrichting van het ‘Experiment gesloten coffeeshopketen’ in consultatie gedaan. De concept-AMvB betreft een nadere invulling van de regels, die zijn opgenomen in het wetsvoorstel experiment gesloten coffeeshopketen dat in juli 2018 aan de Tweede Kamer is aangeboden. Gedurende zes weken kan iedereen op dit concept reageren. Daarnaast schrijven minis...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

9-11-2018

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

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

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

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

23-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

1-10-2018

Kabinet zet in op betere gehandicaptenzorg

Kabinet zet in op betere gehandicaptenzorg

Minister De Jonge (Volksgezondheid, Welzijn en Sport) komt op de eerste dag van de week van de toegankelijkheid met een reeks maatregelen om de zorg voor mensen met een beperking te verbeteren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

27-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.

FDA - U.S. Food and Drug Administration

27-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

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

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

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

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

Europe - EFSA - European Food Safety Authority Publications

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

24-11-2018

Pan-Ophtal® Gel

Rote - Liste

12-11-2018

Tostran 2% Gel

Rote - Liste

9-11-2018

Micotar® Mundgel

Rote - Liste

26-10-2018

Thilo-Tears Gel

Rote - Liste

23-10-2018

Metrogel® 0,75%

Rote - Liste

23-10-2018

Benzaknen® 5 %/10 % Gel

Rote - Liste

4-10-2018

Progestogel

Rote - Liste

1-10-2018

Diclofenac-ratiopharm 30 mg/g Gel

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28-9-2018

Diclofenac AbZ 30 mg/g Gel

Rote - Liste