SOLIFENACINA ACCORD

Informazioni principali

  • Nome commerciale:
  • SOLIFENACINA ACCORD
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

Localizzazione

  • Disponibile in:
  • SOLIFENACINA ACCORD
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Dettagli prodotto:
  • 044688137 - "10 MG COMPRESSE RIVESTITE CON FILM" 10 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688190 - "10 MG COMPRESSE RIVESTITE CON FILM" 100 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688149 - "10 MG COMPRESSE RIVESTITE CON FILM" 20 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688202 - "10 MG COMPRESSE RIVESTITE CON FILM" 200 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688113 - "10 MG COMPRESSE RIVESTITE CON FILM" 3 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688152 - "10 MG COMPRESSE RIVESTITE CON FILM" 30 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688125 - "10 MG COMPRESSE RIVESTITE CON FILM" 5 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688164 - "10 MG COMPRESSE RIVESTITE CON FILM" 50 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688176 - "10 MG COMPRESSE RIVESTITE CON FILM" 60 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688188 - "10 MG COMPRESSE RIVESTITE CON FILM" 90 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688036 - "5 MG COMPRESSE RIVESTITE CON FILM" 10 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688099 - "5 MG COMPRESSE RIVESTITE CON FILM" 100 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688048 - "5 MG COMPRESSE RIVESTITE CON FILM" 20 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688101 - "5 MG COMPRESSE RIVESTITE CON FILM" 200 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688012 - "5 MG COMPRESSE RIVESTITE CON FILM" 3 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688051 - "5 MG COMPRESSE RIVESTITE CON FILM" 30 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688024 - "5 MG COMPRESSE RIVESTITE CON FILM" 5 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688063 - "5 MG COMPRESSE RIVESTITE CON FILM" 50 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688075 - "5 MG COMPRESSE RIVESTITE CON FILM" 60 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato; 044688087 - "5 MG COMPRESSE RIVESTITE CON FILM" 90 COMPRESSE IN BLISTER PVC/PVDC-AL - autorizzato

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 044688
  • Ultimo aggiornamento:
  • 25-06-2017

Foglio illustrativo: composizione, posologia, indicazioni, interazioni, gravidanza, allattamento, effetti indesiderati, controindicazioni

Foglio illustrativo: informazioni per l’utilizzatore

Solifenacina Accord 5 mg compresse rivestite con film

Solifenacina Accord 10 mg compresse rivestite con film

Medicinale equivalente

Legga attentamente questo foglio prima di prendere questo medicinale perché contiene

importanti informazioni per lei.

- Conservi questo foglio. Potrebbe aver bisogno di leggerlo di nuovo.

- Se ha qualsiasi dubbio, si rivolga al medico, al farmacista o all’infermiere.

- Questo medicinale è stato prescritto soltanto per lei. Non lo dia ad altre persone, anche se i

sintomi della malattia sono uguali ai suoi, perché potrebbe essere pericoloso.

- Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo

foglio, si rivolga al medico, al farmacista o all’infermiere. Vedere paragrafo 4.

Contenuto di questo foglio

1. Che cos’è Solifenacina Accord e a cosa serve

2. Cosa deve sapere prima di prendere Solifenacina Accord

3. Come prendere Solifenacina Accord

4. Possibili effetti indesiderati

5. Come conservare Solifenacina Accord

6. Contenuto della confezione e altre informazioni

1. Che cos’è Solifenacina Accord e a cosa serve

Il principio attivo di Solifenacina Accord appartiene al gruppo degli anticolinergici. Questi

medicinali sono utilizzati per ridurre l’attività della vescica iperattiva. Questo permette di

ritardare la necessità di recarsi in bagno e aumenta la quantità di urina che può essere

contenuta all’interno della sua vescica.

Solifenacina Accord è utilizzato per trattare i sintomi della vescica iperattiva. Questi sintomi

comprendono: forte e improvvisa urgenza a urinare senza precedenti segnali, necessità di

urinare frequentemente o bagnarsi perché non si riesce a raggiungere in tempo il bagno.

2. Cosa deve sapere prima di prendere Solifenacina Accord

Non prenda Solifenacina Accord

- se è allergico alla solifenacina o ad uno qualsiasi degli altri componenti di questo medicinale

(elencati al paragrafo 6);

- se ha un impedimento alla minzione o al completo svuotamento della vescica (ritenzione

urinaria);

- se ha un grave problema allo stomaco o all’intestino (compreso il megacolon tossico, una

complicazione associata alla colite ulcerosa);

- se soffre della malattia muscolare definita miastenia grave, che provoca un’estrema

debolezza di alcuni muscoli;

- se soffre di aumentata pressione oculare, con graduale perdita della vista (glaucoma);

- se viene sottoposto a dialisi renale;

- se soffre di gravi malattie del fegato;

- se soffre di gravi malattie renali o di malattie del fegato lievi e viene contemporaneamente

trattato con medicinali che possono ridurre l’eliminazione di Solifenacina Accord

dall’organismo (per esempio, ketoconazolo). Il medico o il farmacista la informeranno in

proposito.

Documento reso disponibile da AIFA il 18/02/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

- Prima di iniziare il trattamento con Solifenacina Accord, informi il medico se presenta o ha

mai presentato una qualsiasi delle condizioni sopraelencate.

Avvertenze e precauzioni

Si rivolga al medico o al farmacista prima di prendere Solifenacina Accord

- se incontra difficoltà di svuotamento della vescica (ostruzione della vescica) o se presenta

difficoltà nel passaggio dell’urina (per esempio, flusso ridotto di urina). Il rischio di accumulo

di urine all’interno della vescica (ritenzione urinaria) è molto più elevato;

- se presenta ostruzioni del sistema digerente (stitichezza);

- se presenta il rischio di ridotta motilità gastrointestinale (movimenti dello stomaco e

dell’intestino). Il medico la informerà circa questa possibilità;

- se soffre di grave malattia renale;

- se soffre di moderata malattia del fegato;

- se ha una lacerazione allo stomaco (ernia iatale) o bruciori di stomaco;

- se ha disturbi del sistema nervoso (neuropatia autonomica).

Bambini e adolescenti

Solifenacina Accord non deve essere utilizzato nei bambini o negli adolescenti al di sotto di

18 anni d’età.

Prima di iniziare il trattamento con Solifenacina Accord, informi il medico se presenta o ha

mai presentato una qualsiasi delle condizioni sopraelencate.

Prima di iniziare il trattamento con Solifenacina Accord, il medico deve accertare che non vi

siano altre cause che portino alla necessità di urinare frequentemente (per esempio,

insufficienza cardiaca (insufficiente capacità del cuore di pompare il sangue) o malattia

renale). Se ha un’infezione delle vie urinarie, il medico le può prescrivere un antibiotico

(trattamento contro particolari infezioni batteriche).

Altri medicinali e Solifenacina Accord

Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe

assumere qualsiasi altro medicinale.

È soprattutto importante informare il medico se sta assumendo:

- altri medicinali anticolinergici, poiché l’efficacia e gli effetti indesiderati di entrambi i

medicinali possono aumentare.

- colinergici che possono ridurre l’efficacia di Solifenacina Accord.

- medicinali, come metoclopramide e cisapride, che stimolano la motilità del tratto

gastrointestinale, poiché Solifenacina Accord può ridurne l’efficacia.

- medicinali, come ketoconazolo, itraconazolo (medicinali usati per il trattamento di infezioni

fungine), ritonavir, nelfinavir (medicinali usati per il trattamento delle infezioni da HIV) e

verapamil, diltiazem (medicinali usati per il trattamento dell’ipertensione e di patologie

cardiache). Questi medicinali diminuiscono la velocità di eliminazione di Solifenacina Accord

dall’organismo.

- medicinali, come rifampicina (medicinale usato per il trattamento della tubercolosi e di altre

infezioni batteriche) e fenitoina, carbamazepina (medicinali usati per il trattamento

dell’epilessia), che possono aumentare la velocità di eliminazione di Solifenacina Accord

dall’organismo.

- medicinali come i bifosfonati, che possono causare o aggravare l’infiammazione della gola

(esofagite).

Solifenacina Accord con cibi, bevande e alcol

Solifenacina Accord può essere assunto con o senza cibo, a seconda delle preferenze.

Gravidanza, allattamento e fertilità

Non deve assumere Solifenacina Accord se è in gravidanza a meno che non sia strettamente

necessario. Non usi Solifenacina Accord se sta allattando, poiché la solifenacina può essere

escreta nel latte materno.

Documento reso disponibile da AIFA il 18/02/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando

con latte materno, chieda consiglio al medico o al farmacista prima di prendere questo

medicinale.

Guida di veicoli e utilizzo di macchinari

Solifenacina Accord può provocare offuscamento della vista e, talvolta, sonnolenza o

affaticamento. Eviti pertanto di guidare o di usare macchinari se si presentano questi effetti

indesiderati.

Solifenacina Accord contiene lattosio monoidrato.

Se il medico le ha diagnosticato un’intolleranza ad alcuni zuccheri, lo contatti prima di

prendere questo medicinale.

3. Come prendere Solifenacina Accord

Prenda questo medicinale seguendo sempre esattamente le istruzioni del medico. Se ha dubbi

consulti il medico o il farmacista.

La dose raccomandata è 5 mg al giorno, a meno che il medico non le abbia detto di prenderne

10 mg al giorno.

Deve ingoiare la compressa intera con un po’ di liquido, per es. un bicchiere d’acqua. Il

medicinale può essere assunto con o senza cibo, a seconda delle preferenze. Non rompere le

compresse.

Bambini e adolescenti

Solifenacina Accord non deve essere utilizzato nei bambini o negli adolescenti al di sotto di

18 anni d’età.

Se prende più Solifenacina Accord di quanto deve

Se ha preso troppo Solifenacina Accord o se un bambino ha preso accidentalmente

Solifenacina Accord, consulti immediatamente il medico o il farmacista.

I sintomi da sovradosaggio possono includere: mal di testa, bocca secca, vertigini, sonnolenza

e visione offuscata, percezione di oggetti non presenti (allucinazioni), sovraeccitazione,

convulsioni epilettiche, problemi respiratori, aumentata frequenza del battito cardiaco

(tachicardia), accumulo di urine nella vescica (ritenzione urinaria) e dilatazione delle pupille

(midriasi).

Se dimentica di prendere Solifenacina Accord

Se ha dimenticato di prendere una dose all’ora abituale, deve prenderla appena si ricorda, a

meno che sia ora di assumere la dose successiva. Non prenda mai più di una dose per giorno.

In caso di dubbi, consulti sempre il medico o il farmacista. Non prenda una dose doppia per

compensare la dimenticanza della dose.

Se interrompe il trattamento con Solifenacina Accord

In caso di sospensione del trattamento con Solifenacina Accord, possono ricomparire o

peggiorare i sintomi di iperattività vescicale. Consulti sempre il medico se sta considerando la

possibilità di sospendere il trattamento.

Se ha qualsiasi dubbio sull’uso di questo medicinale, si rivolga al medico o al farmacista.

4. Possibili effetti indesiderati

Come tutti i medicinali, questo medicinale può causare effetti indesiderati sebbene non tutte le

persone li manifestino.

Documento reso disponibile da AIFA il 18/02/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Se si verifica un attacco allergico o una reazione cutanea grave (p. es. formazione di vesciche

e desquamazione della pelle), deve informare immediatamente il medico o il farmacista.

Angioedema (manifestazione allergica che consiste in un rigonfiamento del tessuto appena

sotto la superficie cutanea) con ostruzione delle vie aeree (difficoltà di respirazione) è stato

riportato in alcuni pazienti in trattamento con solifenacina succinato (Solifenacina Accord). In

caso di insorgenza di angioedema, il trattamento con solifenacina succinato (Solifenacina

Accord) deve essere interrotto immediatamente e deve essere istituita una terapia e/o adottate

misure appropriate.

Solifenacina Accord può causare i seguenti altri effetti indesiderati:

Molto comuni (possono colpire più di 1 persona su 10)

- bocca secca

Comuni (possono colpire fino a 1 persona su 10)

- visione offuscata

- stitichezza, nausea, indigestione con sintomi quali sensazione di gonfiore addominale,

dolore addominale, eruttazione, nausea e bruciore di stomaco (dispepsia), sensazione di

fastidio allo stomaco

Non comuni (possono colpire fino a 1 persona su 100)

- infezioni delle vie urinarie, infezioni vescicali

- sonnolenza

- anomala percezione del gusto (disgeusia)

- secchezza (irritazione) oculare

- secchezza nasale

- malattia da reflusso (reflusso gastroesofageo)

- secchezza della gola

- secchezza cutanea

- difficoltà alla minzione

- stanchezza

- accumulo di liquidi nella parte inferiore della gamba (edema)

Rari (possono colpire fino a 1 persona su 1000)

- accumulo di ingenti quantità di feci nell’intestino crasso (occlusione da feci)

- aumento della quantità di urina all’interno della vescica causato dall’incapacità di

svuotamento della vescica (ritenzione urinaria)

- capogiri, cefalea

- vomito

- prurito, eruzione cutanea

Molto rari (possono colpire fino a 1 persona su 10.000)

- allucinazioni, confusione

- eruzione allergica

Non noti (la frequenza non può essere definita sulla base dei dati disponibili)

- diminuzione dell’appetito, alti livelli di potassio nel sangue che possono causare ritmo

cardiaco anomalo

- aumento della pressione oculare

- modificazioni dell’attività elettrica cardiaca (ECG), battito cardiaco irregolare, sensazione di

palpitazioni, battito cardiaco accelerato

- disturbi della voce

- disturbi del fegato

- debolezza muscolare

- disturbi renali

Documento reso disponibile da AIFA il 18/02/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Segnalazione degli effetti indesiderati

Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio,

si rivolga al medico o al farmacista. Lei può inoltre segnalare gli effetti indesiderati

direttamente

tramite

sistema

nazionale

segnalazione

all’indirizzo

www.agenziafarmaco.gov.it/it/responsabili. Segnalando gli effetti indesiderati, lei può

contribuire a fornire maggiori informazioni sulla sicurezza di questo medicinale.

5. Come conservare Solifenacina Accord

Questo medicinale non richiede alcuna condizione particolare di conservazione.

Conservi questo medicinale fuori dalla vista e dalla portata dei bambini.

Non usi questo medicinale dopo la data di scadenza che è riportata sul blister o sulla

scatola dopo SCAD. La data di scadenza si riferisce all’ultimo giorno di quel mese.

Non usi questo medicinale se nota che la confezione è danneggiata o mostra segni di

manomissione.

Non getti alcun medicinale nell’acqua di scarico e nei rifiuti domestici. Chieda al

farmacista come eliminare i medicinali che non utilizza più. Questo aiuterà a

proteggere l’ambiente.

6. Contenuto della confezione e altre informazioni

Cosa contiene Solifenacina Accord

Il principio attivo è solifenacina succinato.

Ciascuna compressa rivestita con film contiene 5 mg di solifenacina succinato, equivalenti a

3,8 mg di solifenacina.

Ciascuna compressa rivestita con film contiene 10 mg di solifenacina succinato, equivalenti a

7,5 mg di solifenacina.

Gli altri componenti sono:

Nucleo della compressa: Lattosio monoidrato, Amido di mais, Ipromellosa (3 cps) (E464),

Magnesio stearato (E572).

Rivestimento: Ipromellosa (5 cps) (E464), Talco (E553b), Titanio diossido (E171), Macrogol

6000 (E1521), Ferro ossido giallo (E172) (Per 5 mg), Ferro ossido rosso (E172) (Per 10 mg).

Descrizione dell’aspetto di Solifenacina Accord e contenuto della confezione

Solifenacina Accord 5 mg: compressa rivestita con film rotonda, biconvessa, di colore giallo

chiaro, dal diametro approssimativo di 7,1 mm, con impresso “EG” su un lato e “1” sull’altro.

Solifenacina Accord 10 mg: compressa rivestita con film rotonda, biconvessa, di colore rosa

chiaro, dal diametro approssimativo di 7,1 mm, con impresso “EG” su un lato e “2” sull’altro.

Solifenacina Accord è disponibile in confezioni da 3, 5, 10, 20, 30, 50, 60, 90, 100 o 200

compresse in blister PVC/PVDC-Alluminio.

E’ possibile che non tutte le confezioni siano commercializzate.

Titolare dell’autorizzazione all’immissione in commercio

Accord Healthcare Limited,

Sage House, 319 Pinner Road,

North Harrow,

HA1 4HF, Middlesex,

Regno Unito

Produttori

Documento reso disponibile da AIFA il 18/02/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

Accord Healthcare Limited

Ground Floor, Sage house, 319 Pinner road, Harrow, Middlesex, HA1 4HF, Regno

Unito

Wessling Hungary Kft.,

Fòti ùt 56, Budapest, 1047, Ungheria

Pharmacare Premium Ltd.

HHF003, Hal Far Industrial Estate, Birzebbugia, BBG3000, Malta

Questo prodotto medicinale è autorizzato negli Stati Membri dello Spazio Economico

Europeo con le seguenti denominazioni:

Stato

Nome proposto

Danimarca

Solifenacinsuccinat Accord 5mg/10 mg filmovertrukne tabletter

Austria

Solifenacin Accord 5 mg/10 mg Filmtabletten

Germania

Solifenacin Accord 5 mg/10 mg Filmtabletten

Finlandia

Solifenacin Accord 5 mg/10 mg kalvopäällysteinen tabletti

Irlanda

Solifenacin succinate 5 mg/10 mg film-coated tablets

Italia

Solifenacina Accord

Paesi Bassi

Solifenacinesuccinaat Accord 5 mg/10 mg, filmomhulde tabletten

Norvegia

Solifenacin Accord

Polonia

Solifenacin Accord

Svezia

Solifenacin Accord 5 mg/10 mg filmdragerad tabletter

Regno Unito

Solifenacin Succinate 5 mg/10 mg Film-coated Tablets

Spagna

Solifenacin Accord 5 mg/10 mg comprimidos recubiertos con película

Francia

Solifenacin Accord 5 mg/10 mg comprimé pelliculé

Questo foglio illustrativo è stato aggiornato il

Documento reso disponibile da AIFA il 18/02/2017

Esula dalla competenza dell’AIFA ogni eventuale disputa concernente i diritti di proprietà industriale e la tutela brevettuale dei dati relativi all’AIC dei

medicinali e, pertanto, l’Agenzia non può essere ritenuta responsabile in alcun modo di eventuali violazioni da parte del titolare dell'autorizzazione

all'immissione in commercio (o titolare AIC).

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Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

EFSA's activities on emerging risks in 2017

EFSA's activities on emerging risks in 2017

Published on: Mon, 14 Jan 2019 The main objectives of EFSA's activities on emerging risks are: (i) to carry out activities to identify emerging risks in the areas within the remit of EFSA; and (ii) to develop and improve emerging risk identification methodologies and approaches. The current technical report summarises the activities of all groups involved in the emerging risk identification procedure, the issues identified in the course of 2017, a description of methodologies being developed and collabo...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

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

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

Published on: Mon, 14 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluometuron. To assess the occurrence of fluometuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance sedaxane. To assess the occurrence of sedaxane residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance triazoxide. To assess the occurrence of triazoxide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008, as well as the European authorisations reported by Member States. Bas...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-1-2019

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

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

Published on: Tue, 08 Jan 2019 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance chromafenozide. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for chromafenozide within the EU. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue limits) for this active subst...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Resapath

Resapath

The development of antimicrobial resistance in animal and human bacteria is a major public health issue requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to combat antimicrobial resistance, in particular by coordinating the French Surveillance Network for Antimicrobial Resistance in Pathogenic Bacteria of Animal Origin (Resapath), which is devoted to monitoring resistance in bact...

France - Agence Nationale du Médicament Vétérinaire

8-1-2019

Antimicrobial resistance

Antimicrobial resistance

Antimicrobial resistance is a major international human and animal health issue, because the emergence and spread of drug-resistant strains of bacteria call into question the efficacy of these treatments in humans and animals alike. Preserving the effectiveness of antibiotics is therefore a genuine public health challenge requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to addr...

France - Agence Nationale du Médicament Vétérinaire

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

20-12-2018

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

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

Published on: Wed, 19 Dec 2018 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 States, the applican...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-12-2018

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

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

Published on: Mon, 17 Dec 2018 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance pencycuron. To assess the occurrence of pencycuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EC) No 33/2008 as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

15-12-2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

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

17-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

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 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

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

2-10-2018

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

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

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

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

27-9-2018

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

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

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

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

25-9-2018

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

Daiso Holdings Ltd. recalls Daiso Brand Consumer Chemical Products

The recalled products have not been properly classified according to the Consumer Chemicals and Containers Regulations, 2001, in order to ensure appropriate hazard labelling. These regulations are empowered by the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

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

13-9-2018

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

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

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Modelling of inactivation through heating for quantitative microbiological risk assessment (QMRA)

Published on: Mon, 27 Aug 2018 00:00:00 +0200 EFSA regards the household as a stage in the food chain that is important for the final number of food‐borne infections. The fate of a pathogen in the private kitchen largely depends on consumer hygiene during preparation of food and on its proper cooking, especially in the case of meat. Unfortunately, detailed information on the microbiological survival in meat products after heating in the consumer kitchen is lacking. The aim of the study was to improve th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

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

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

1-9-2018

Acknowledgement:EFSA  wishes  to  thank  the  rapporteur  Member  State  Denmark  for  thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Acknowledgement:EFSA wishes to thank the rapporteur Member State Denmark for thepreparatory work on this scientific output.Suggested citation:EFSA (European Food Safety Authority), Brancato A, Brocca D, Carrasco Cabrera L,De Lentdecker C, Erdos

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance napropamide. To assess the occurrence of napropamide residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl...

Europe - EFSA - European Food Safety Authority Publications

1-9-2018

Review of the existing MRLs for fenbuconazole

Review of the existing MRLs for fenbuconazole

Published on: Fri, 31 Aug 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fenbuconazole. To assess the occurrence of fenbuconazole residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

National summary reports on pesticide residue analysis performed in 2016

National summary reports on pesticide residue analysis performed in 2016

Published on: Tue, 07 Aug 2018 00:00:00 +0200 In accordance with Article 31 of Regulation (EC) No 396/2005, European Union (EU) Member States have to communicate to the European Food Safety Authority (EFSA) the results of their official controls on pesticide residues in food. In the framework of this communication, the EU Member States, Iceland and Norway provided a short summary report outlining the main findings of the control activities during the reference year. This technical report is the compilat...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Pelgraz (Accord Healthcare Limited)

Pelgraz (Accord Healthcare Limited)

Pelgraz (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6288 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/003961/0000

Europe -DG Health and Food Safety

24-9-2018

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Accord Healthcare Limited)

Lenalidomide Accord (Active substance: lenalidomide) - Centralised - Authorisation - Commission Decision (2018)6237 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4857

Europe -DG Health and Food Safety