TRUE TEST SMARTPRACTICE

Informazioni principali

  • Nome commerciale:
  • TRUE TEST SMARTPRACTICE
  • Codice ATC:
  • V
  • Utilizzare per:
  • Esseri umani
  • Tipo di medicina:
  • Farmaco allopatico

Documenti

Localizzazione

  • Disponibile in:
  • TRUE TEST SMARTPRACTICE
    Italia
  • Lingua:
  • italiano

Informazioni terapeutiche

  • Dettagli prodotto:
  • 044858013 - "CEROTTI PER TEST DI PROVOCAZIONE CUTANEA" 1 UNIT: 2 PANNELLI DA 12 APTENI CIASCUNO - autorizzato; 044858025 - "CEROTTI PER TEST DI PROVOCAZIONE CUTANEA" 10 UNIT: 2 PANNELLI DA 12 APTENI CIASCUNO - autorizzato

Altre informazioni

Status

  • Fonte:
  • AIFA - Agenzia Italiana del Farmaco
  • Numero dell'autorizzazione:
  • 044858
  • Ultimo aggiornamento:
  • 07-01-2018

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

Foglio illustrativo: informazioni per l’utilizzatore

T.R.U.E. Test SmartPractice Denmark, cerotto per test di provocazione

T.R.U.E. Test SmartPractice Denmark consiste in 2 pannelli di cerotto chirurgico, ciascuno con 12

celle. Ogni cella è rivestita con un film contenente uno specifico allergene o una miscela di allergeni.

Pannello 1

microgrammo/cm

microgrammo/cella

Solfato di nickel

Alcoli della lana

1000

Neomicina solfato

Bicromato di potassio

Caine mix

Miscela di fragranze

Colofonia

1200

Miscela di parabeni

1000

Miscela di chinoline

Balsamo del Perù

Etilendiamina dicloridrato

Cloruro di cobalto

Pannello 2

Resina-p-ter-

butilfenolformaldeidica

Epossiresina

Carba mix

Miscela di gomma nera

Metil(cloro)isotiazolinone

Quaternium-15

Mercaptobenzotiazolo

p-fenilendiammina

Formaldeide

Mercapto mix

Timerosal

Tiurami mix

5 parti di benzocaina, 1 parte di cincocaina cloridrato e tetracaina cloridrato.

5 parti di geraniolo e muschio di quercia, 4 parti di idrossicitronellale e alcool

cinnamilico, 2 parti di aldeide cinnamica e eugenolo e 1 parte di isoeugenolo e aldeide

alfa amil cinnamica.

Pesi uguali di metil-paraidrossibenzoato, etil-paraidrossibenzoato, propil-

paraidrossibenzoato, butil-paraidrossibenzoato e benzil-paraidrossibenzoato.

Pesi uguali di cliochinolo e clorchinaldolo.

Pesi uguali di difenilguanidina, dietilditiocarbammato di zinco e dibutilditiocarbammato

di zinco.

2 parti di N-isopropil-N'-fenil parafenilendiamina, 5 parti di N-cicloesil- N'- fenil

parafenilendiamina e 5 parti di N, N'-difenil parafenilendiamina.

In realtà contiene N-idrossimetil succinimide.

Pesi uguali di morfolinilmercaptobenzotiazolo, N-cicloesil benzotiazil sulfenamide e

dibenzotiazil disulfide.

Pesi uguali di disulfiram, dipentametilenetiuram disolfuro, tetrametiltiuram disolfuro e

tetrametiltiuram monosolfuro.

Legga attentamente questo foglio prima di usare 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.

1

8

Documento reso disponibile da AIFA il 25/07/2018

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).

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:

Che cos’è T.R.U.E. Test SmartPractice Denmark e a cosa serve

Cosa deve sapere prima di usare T.R.U.E. Test SmartPractice Denmark

Come usare T.R.U.E. Test SmartPractice Denmark

Possibili effetti indesiderati

Come conservare T.R.U.E. Test SmartPractice Denmark

Contenuto della confezione e altre altre informazioni

1.

Che cos’è T.R.U.E. Test SmartPractice Denmark e a cosa serve

T.R.U.E. Test SmartPractice Denmark è usato per diagnosticare la dermatite allergica da contatto. La

dermatite da contatto è una reazione della pelle causata dall’esposizione a sostanze estranee che causa

una reazione allergica.

T.R.U.E. Test SmartPractice Denmark è un test in cerotto pronto all’uso per la determinazione della

causa della dermatite allergica da contatto.

T.R.U.E. Test SmartPractice Denmark è per uso esclusivo negli adulti.

Il test consiste di 2 pannelli di cerotto chirurgico. Ciascun pannello contiene 12 celle. Ogni cella è

rivestita con un film che contiene una sostanza che può causare una reazione della pelle nelle persone

sensibili. Tali sostanze sono chiamate allergeni. Ciascuna cella contiene un allergene differente.

T.R.U.E. Test SmartPractice Denmark contiene 24 tra gli allergeni/miscele di allergeni più comuni.

T.R.U.E. Test SmartPractice Denmark funziona mostrando se lei è allergico a una qualsiasi delle

sostanze del test (allergeni) nelle celle. Se una sostanza alla quale lei è allergico viene a contatto con la

sua pelle causa una reazione infiammatoria chiamata dermatite da contatto.

Queste sostanze possono essere un componente del suo profumo o dopobarba, di una lozione o di una

crema, dei guanti di gomma, delle sostanze chimiche industriali, ecc. Le sostanze contenute in

T.R.U.E. Test SmartPractice Denmark sono allergeni ben noti. Se lei è allergico alla sostanza

contenuta in una particolare cella di T.R.U.E. Test SmartPractice Denmark, allora la pelle al di sotto di

quella cella reagirà ad essa, arrossandosi ed infiammandosi. Se lei non è allergico alla sostanza in

quella particolare cella, la pelle al di sotto di esso non reagirà. Può essere allergico alle sostanze

contenute in più di una cella.

2.

Cosa deve sapere prima di usare T.R.U.E. Test SmartPractice Denmark

Non usi T.R.U.E. Test SmartPractice Denmark

se soffre di dermatite grave o generalizzata. Il test deve essere rimandato fino a che la fase

acuta della dermatite non si è conclusa.

se è allergico ad uno qualsiasi degli altri componenti di T.R.U.E. Test SmartPractice Denmark

(elencati al paragrafo 6).

Avvertenze e precauzioni

Eviti di esporre la zona testata al sole. L’abbronzatura può portare a non rilevare una reazione

positiva ad allergeni ai quali in realtà lei è allergico.

Eviti di sudare copiosamente mentre indossa i pannelli del cerotto per il test.

Se sta assumendo medicinali che sopprimono il sistema immunitario quali steroidei (ad es.

prednisolone) o se se sta usando unguenti/creme a base di steroidi (ad es. idrocortisone).

Questi non devono essere utilizzati per almeno due settimane prima del test.

2

8

Documento reso disponibile da AIFA il 25/07/2018

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 ha la sindrome della cute eccitata (excited skin syndrome - angry back). Si tratta di un stato

di eccessiva irritabilità della pelle causata da una reazione in altre parti del corpo. Se reagisce

a tutti i cerotti, il medico può aver bisogno di ripetere il test un altro giorno.

Se ha avuto reazioni anafilattoidi in precedenza. L’uso di T.R.U.E. Test SmartPractice

Denmark deve essere considerato attentamente.

Si rivolga al medico prima di usare T.R.U.E. Test SmartPractice Denmark se una qualsiasi di queste

condizioni la riguarda. Il medico saprà decidere cosa fare.

Sensibilizzazione: In rari casi può diventare sensibile a una sostanza sui cerotti mentre sta usando

T.R.U.E. Test SmartPractice Denmark. Una reazione al test che compare più di 10 giorni dopo

l’applicazione può essere un segno di una sensibilizzazione da contatto.

TRUE Test deve essere applicato solo sulla pelle:

senza acne

senza cicatrici

senza dermatite

in condizione tale da non interferire con i risultati del test. Se ha dei dubbi, deve verificare con

il medico.

Deve evitare l’umidità intorno al test. Pertanto, quando fa il bagno o la doccia, deve stare attento a non

bagnare il pannello per il test o la zona circostante. Se il pannello per il test si bagna può staccarsi e le

sostanze del test possono essere lavate via.

Evitare qualsiasi attività che possa causare il distacco del cerotto, come prendere il sole o l’attività

fisica.

L’idrossianisolo butilato (BHA) (E320) e l’idrossitoluene butilato (BHT) (E312) sono presenti nel

cerotto allergenico n. 7 Colofonia (pannello 1) per motivi di stabilità. BHA e BHT possono causare

reazioni cutanee locali (per es. dermatite da contatto), e quindi si può verificare un risultato falsamente

positivo alla Colofonia.

Bambini

L’uso di T.R.U.E. Test SmartPractice Denmark non è raccomandato nei bambini, poiché la sua

sicurezza ed efficacia non è stata stabilita in questi pazienti.

Altri medicinali e T.R.U.E. Test SmartPractice Denmark

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

qualsiasi altro medicinale, inclusi quelli ottenuti senza prescrizione, prima di applicare T.R.U.E. Test

SmartPractice Denmark. Ricordi che lo specialista può non sapere degli altri medicinali che sta

prendendo.

Poiché gli steroidi possono sopprimere la risposta positiva al test, l’uso di steroidi per via topica sul

sito del test o di steroidi per via orale a dosi pari o superiori a 20 mg di prednisolone al giorno deve

essere interrotto almeno due settimane prima del test.

Gravidanza, allattamento e fertilità

Le donne in gravidanza non devono usare T.R.U.E. Test SmartPractice Denmark. È importante

informare il medico se è in corso una gravidanza o se sospetta una gravidanza.

Non deve allattare con latte materno il suo bambino durante l’uso di T.R.U.E. Test SmartPractice

Denmark.

Guida di veicoli e utilizzo di macchinari

È improbabile che T.R.U.E. Test SmartPractice Denmark abbia effetti sulla sua capacità di guidare

veicoli e usare macchinari. Ne discuta con il medico se ha preoccupazioni al riguardo.

3

8

Documento reso disponibile da AIFA il 25/07/2018

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).

3.

Come usare T.R.U.E. Test SmartPractice Denmark

T.R.U.E. Test SmartPractice Denmark deve essere applicato da un medico

1. Aprire la confezione e rimuovere il pannello di T.R.U.E. Test SmartPractice Denmark.

2. Rimuovere la plastica di protezione dalla superficie del pannello. Fare attenzione a non toccare le

sostanze del test. Un foglio essiccante è incluso nella confezione del pannello 2 per motivi di stabilità.

3. Posizionare il test sulla parte superiore della schiena del paziente. Può tuttavia essere utilizzata

anche la parte superiore del braccio. Dal centro del pannello, appiattire i bordi verso l’esterno,

assicurandosi che ciascun allergene aderisca bene alla cute. I due pannelli vanno posizionati su ciascun

lato della colonna vertebrale a una distanza di pochi centimetri.

4. Le due incisure sui pannelli (in alto a sinistra e sul bordo inferiore) devono essere indicate con un

pennarello ad uso medico.

Deve indossare i pannelli del test per 48 ore senza rimuoverli. Deve fare attenzione a non bagnare

l’area testata (acqua, sudore).

Dopo 48 ore i pannelli possono essere rimossi da lei o dal suo medico.

4

8

Documento reso disponibile da AIFA il 25/07/2018

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).

Quando deve essere letto il test?

Il medico leggerà la reazione mezz’ora dopo la rimozione del test e di nuovo 1-2 giorni dopo la

rimozione, quando le reazioni allergiche sono del tutto sviluppate e le possibili reazioni irritanti sono

svanite. Alcuni allergeni possono a volte causare reazioni che non compaiono fino a 4-5 giorni dopo la

rimozione del test. Informi il medico se ciò accade.

Cosa cercherà il medico?

Il medico esaminerà attentamente la zona testata per i segni di una reazione allergica. Questa reazione

consiste di solito in un’eruzione con gonfiore, arrossamento e piccole vesciche. Il solo arrossamento,

tuttavia, non significa necessariamente che si tratti di una reazione allergica. Se lei è allergico, il

medico le fornirà le seguenti informazioni:

dove, nel suo ambiente giornaliero, è probabile che venga a contatto con le sostanze irritanti

come evitare al meglio queste sostanze. Il medico può suggerire delle alternative agli oggetti

che deve evitare

Se ha dubbi consulti il medico o il farmacista.

Contatti il medico se manifesta grave fastidio nel sito del test. Il medico può decidere di rimuovere il

test.

Se il cerotto viene rimosso o si stacca troppo presto, è possibile che le reazioni positive agli allergeni

ai quali è effettivamente allergico possano non essere evidenziate. Contatti il medico se il cerotto viene

rimosso o si stacca prima di 48 ore.

Possibili effetti indesiderati

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

li manifestino.

Effetti indesiderati molto comuni (interessano più di 1 persona su 10):

Può verificarsi irritazione causata dal cerotto chirurgico adesivo, ma di solito scompare

rapidamente.

Reazioni al test di lunga durata. Una reazione positiva al test scompare di solito entro 1-2

settimane, mentre una reazione al test di lunga durata può persistere per settimane o mesi.

Effetti indesiderati comuni (interessano più di 1 persona su 100 ma meno di 1 su 10):

Le reazioni al test possono lasciare una zona della pelle temporaneamente pallida o più scura.

Effetti indesiderati non comuni (interessano più di 1 persona su 1.000 ma meno di 1 su 100):

Riacutizzazione della dermatite

Effetti indesiderati rari (interessano più di 1 persona su 10.000 ma meno di 1 su 1.000):

Con il test può verificarsi sensibilizzazione ad una sostanza del pannello per il test.

Reazioni anafilattiche (reazioni sistemiche, possibilmente associate ad una caduta nella pressione

sanguigna pericolosa per la vita) si sono verificate in casi estremamente rari e solo in relazione a certe

sostanze. I centri di allergologia sono preparati a trattare questi incidenti per motivi diversi. Le

reazioni di tipo anafilattico in relazione all’applicazione di T.R.U.E. Test SmartPractice Denmark non

sono documentate.

Segnalazione degli effetti indesiderati

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

al medico. Lei può inoltre segnalare gli effetti indesiderati direttamente tramite il sistema nazionale di

segnalazione all’inidrizzo http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

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8

Documento reso disponibile da AIFA il 25/07/2018

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).

Segnalando gli effetti indesiderati lei può contribuire a fornire maggiori informazioni sulla sicurezza di

questo medicinale.

Come conservare T.R.U.E. Test SmartPractice Denmark

Conservare in frigorifero (2

C – 8

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

Non usi questo medicinale dopo la data di scadenza che è riportata sulla confezione. La data di

scadenza si riferisce all’ultimo giorno di quel mese.

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 T.R.U.E. Test SmartPractice Denmark

Oltre ai principi attivi elencati nella prima pagina, il test contiene i seguenti eccipienti:

Cerotto in fibre di poliestere con legante (copolimero etilene acetato) con adesivo acrilico, celle in

polistere, povidone 90, idrossipropil cellulosa, metil cellulosa,

-ciclodestrina, sodio carbonato, sodio

bicarbonato, butilidrossianisolo e butilidrossitoluene.

Descrizione dell’aspetto di T.R.U.E. Test SmartPractice Denmark e contenuto della confezione

Ciascun pannello è ricoperto da uno foglio di protezione in polietilene rivestito con silicone e poi

confezionato in bustine ermetiche in foglio laminato.

La bustina del pannello 2 contiene anche un essiccante per mantenere gli allergeni intatti durante la

conservazione.

Contenuto della confezione: 1 o 10 test (1 test = un pannello 1 e un pannello 2). E’ possibile che non

tutte le confezioni siano commercializzate.

Titolare dell’autorizzazione all’immissione in commercio e produttore

SMARTPRACTICE DENMARK ApS

Herredsvejen 2

3400 Hillerød

Denmark

info@smartpractice.dk

Questo medicinale è autorizzato negli Stati Membri dello Spazio Economico Europeo con le

seguenti denominazioni:

Repubblica Ceca: EPITEST

Danimarca: TRUE TEST 24

Francia: TRUE Test SmartPractice Denmark

Germania: TRUE TEST 24

Italia: T.R.U.E. TEST SmartPractice Denmark

Paesi Bassi: TRUE TEST

Polonia: TRUE TEST 24

Portogallo: Truetest 24

Slovacchia: TRUE TEST 24

Spagna: TRUE TEST 24

Svezia: Mekostest

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Documento reso disponibile da AIFA il 25/07/2018

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).

Regno Unito: TRUE TEST 24

Questo foglio illustrativo è stato aggiornato il

Tagliare con le forbici-------------------------------------------------------------------------------------------------------

Le informazioni seguenti sono destinate esclusivamente ai medici o agli operatori sanitari:

In ciascuna confezione di T.R.U.E. Test SmartPractice Denmark viene fornita una griglia di

identificazione per una rapida e agevole identificazione di qualsiasi allergene, che causa una reazione.

Per assicurare il corretto posizionamento, i segni sulla cute devono corrispondere alle incisure sulla

tabella. Presti attenzione alla differenza tra le pagine 1 e 2 della griglia che corrispondono ai pannelli 1

e 2.

Il metodo di interpretazione raccomandato dall’International Contact Dermatitis Research Group è:

Reazione negativa

Reazione dubbia: solo un lieve eritema maculare, nessuna infiltrazione o infiltrazione

molto scarsa

Reazione positiva debole (non vescicolare): eritema, lieve infiltrazione, possibili papule

Reazione positiva forte (vescicolare): eritema, infiltrazione, papule, vesciche

Reazione positiva estrema: forte eritema, infiltrato, vescicole coalescenti

Reazione irritativa di diversi tipi

Non testato

Nota

I pazienti che mostrano una reazione negativa possono essere comunque sensibilizzati ad

un’altra sostanza non inclusa in questo pannello per il test. Inoltre, possono verificarsi risultati

falsi-negativi. Può essere indicato ripetere il test o effettuare un test con sostanze

complementari.

Una reazione positiva deve soddisfare i criteri per una reazione allergica (eritema papulare o

vescicolare e infiltrazione).

Pustole ed eritema omogeneo o follicolare a macchie senza infiltrazione sono in genere segni

di irritazione e non indicano allergia.

Nella valutazione di una risposta positiva al test non è importante il numero di segni + assegnati alla

risposta al test ma determinare se la risposta è una reazione veramente positiva (causata da un’allergia)

o una reazione irritativa non specifica.

A volte, la neomicina solfato e la p-fenilendiammina causano reazioni che possono non comparire fino a 4-

5 giorni dopo l’applicazione delle strisce del test. I pazienti devono essere istruiti a segnalare tali reazioni.

Se necessario, la reazione ritardata potrà essere verificata nel corso di un’ulteriore visita medica dopo 5-7

giorni, con una lettura ritardata.

Controindicazioni

Dermatite grave o generalizzata. Il test deve essere rimandato fino al superamento della fase acuta.

Ipersensibilità nota agli altri eccipienti contenuti nel test oltre ai principi attivi.

Avvertenze speciali e precauzioni di impiego

La sensibilizzazione a un sostanza del pannello del test avviene solo raramente. Una reazione al test

che avviene dopo più di 10 giorni dall’applicazione può essere un segno di sensibilizzazione da

contatto.

La sindrome della cute eccitata (Excited skin syndrome - angry back) è uno stato di iperattività indotto

dalla dermatite in altre parti del corpo o da una forte reazione positiva al test cutaneo. Pertanto, i

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Documento reso disponibile da AIFA il 25/07/2018

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).

risultati del test devono essere valutati attentamente in pazienti con risultati positivi in più celle allo

stesso tempo. Per determinare quali reazioni sono false positive, può essere necessario rifare il test in

un momento successivo.

L’uso di T.R.U.E. Test SmartPractice Denmark nei pazienti con anamnesi di reazioni anafilattoidi deve

essere attentamente valutato prima della sua applicazione.

L’eccessiva sudorazione e l’esposizione al sole del sito di applicazione del test deve essere evitata.

L’abbronzatura può diminuire la reattività al test e causare risultati falsamente negativi.

Evitare di applicare il test sulla pelle con acne, cicatrici, dermatiti o qualsiasi altra condizione che può

interferire con i risultati del test.

Se si sviluppa una reazione grave al test, il paziente può essere trattato con corticosteroidi per via

topica e in rari casi con corticosteroidi per via sistemica.

L’idrossianisolo butilato (BHA) (E320) e l’idrossitoluene butilato (BHT) (E312) sono presenti come

antiossidanti nel cerotto contenente l’allergene n. 7 Colofonia (pannello 1). BHA e BHT possono

causare reazioni cutanee locali (per es. dermatite da contatto), e quindi si può verificare un risultato

falsamente positivo alla Colofonia.

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8

Documento reso disponibile da AIFA il 25/07/2018

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).

15-1-2019

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 and subcombinations independently of their origin for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2013‐11

Published on: Mon, 14 Jan 2019 Maize MON 89034 × 1507 × MON 88017 × 59122 × DAS‐40278‐9 (five‐event stack maize) was produced by conventional crossing to combine five single events: MON 89034, 1507, MON 88017, 59122 and DAS‐40278‐9. The GMO Panel previously assessed the 5 single maize events and 11 of their subcombinations and did not identify safety concerns. No new data on the single maize events or their 11 subcombinations that could modify the original conclusions on their safety were identified. Th...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-1-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations

FDA issues three documents that launch next phase of Pre-Cert Pilot Program to test new approaches for the review of digital health device applications.

FDA - U.S. Food and Drug Administration

4-1-2019

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds

Shamrock Farms Issues Voluntary Recall of 2% Reduced Fat Vanilla Half Gallon Milk Due to Undeclared Almonds

Shamrock Farms of Phoenix, Arizona is issuing a voluntary recall of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Best Before Date 3/16/2019. The recall comes after a product retain of Shamrock Farms 2% Reduced Fat Vanilla Half Gallon Milk with Use By 03/16/19 Time Stamp 08:18-11:13 04-05 #1, tested positive for an undeclared tree nut (almond) allergen.

FDA - U.S. Food and Drug Administration

26-12-2018

Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls

Apio Inc. Expands Voluntary Recall of Eat Smart Salad Shake Ups Single-Serve Bowls

Apio Inc. of Guadalupe, California is expanding a voluntary recall of Eat Smart Salad Shake Ups single-serve bowls. The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that another random sample of Eat Smart Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. single-serve bowls (5.5oz) with Best Before Date of Dec 29, 2018, Lot 112 346, tested positive for Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail ...

FDA - U.S. Food and Drug Administration

21-12-2018

FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

FDA permits marketing of a diagnostic test to aid in measuring nutrients in breast milk

The FDA authorized use of a new test that measures nutrients in breast milk providing healthcare professionals with tool to aid in the nutritional management of newborns.

FDA - U.S. Food and Drug Administration

20-12-2018

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. The products have been found to inaccurately report high INR test results.

FDA - U.S. Food and Drug Administration

20-12-2018

Health Canada releases test results of certain sartan drugs

Health Canada releases test results of certain sartan drugs

Health Canada has released the results of its testing of sartan drugs in Canada. Health Canada tested samples of certain sartan drugs (valsartan, candesartan, irbesartan, losartan, and olmesartan), which represent numerous products, as part of its ongoing collaborative work to address impurities found in some sartan drugs in Canada and internationally.

Health Canada

16-12-2018

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. Voluntarily Recalls Five Skus of Eat Smart Single-Serve Salad Shake Ups™

Apio, Inc. of Guadalupe, California is voluntarily recalling five SKUs of Eat Smart® Single-Serve Salad Shake Ups™ (bowls). The recall comes after the Canadian Food Inspection Agency (CFIA) informed the company that one random sample of Eat Smart Single-Serve Salad Shake Ups Sweet Kale/Chou Frise Doux 156 gr. (5.5oz) with Best Before of Dec 14, 2018 tested positive for Listeria Monocytogenes. As a precautionary measure, we are recalling all products produced on the same day, same production line, as the ...

FDA - U.S. Food and Drug Administration

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

8-12-2018

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2018 in the context of Commission Regulation (EU) No 1152/2011

Published on: Fri, 07 Dec 2018 This report is part of the `Echinococcus multilocularis surveillance’ scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, Malta, the United Kingdom (UK) and Norway in their respective surveillance programmes. The surveillance programmes of these five countries were evaluated by checking the information submitted by each of them an...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Bonify recalls 2 lots of dried cannabis products

Bonify recalls 2 lots of dried cannabis products

The recalled product may not meet some of the microbial and chemical contaminant limits as specified by the Good Production Practices requirements of the Cannabis Regulations.Documentation confirming test results could not be matched to the lot specific numbers.

Health Canada

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA - U.S. Food and Drug Administration

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

30-11-2018

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Epidemiological analyses of African swine fever in the European Union (November 2017 until November 2018)

Published on: Thu, 29 Nov 2018 This update on the African swine fever (ASF) outbreaks in the EU demonstrated that out of all tested wild boar found dead, the proportion of positive samples peaked in winter and summer. For domestic pigs only, a summer peak was evident. Despite the existence of several plausible factors that could result in the observed seasonality, there is no evidence to prove causality. Wild boar density was the most influential risk factor for the occurrence of ASF in wild boar. In th...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-11-2018

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation

The FDA approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

FDA - U.S. Food and Drug Administration

28-11-2018

CLS Sales Inc. recalls Wind Up Fish & Lion Toys

CLS Sales Inc. recalls Wind Up Fish & Lion Toys

Health Canada’s sampling and evaluation program has determined that the toys do not meet the Canadian safety requirements for toys. Additionally, the fish toy released small parts during testing, which could pose as a choking hazard for young children.

Health Canada

28-11-2018

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Information Update - Mylan-Valsartan medications voluntarily recalled as a precaution due to an impurity

Mylan Pharmaceuticals ULC is voluntarily recalling four lots of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg strength) after testing found low levels of an impurity, N-nitrosodiethylamine (NDEA).

Health Canada

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

FDA scientists tested 26 separate kratom products and found lead and nickel at levels not considered safe for human consumption

FDA - U.S. Food and Drug Administration

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Extensive literature search, selection for relevance and data extraction of studies related to the toxicity of PCDD/Fs and DL‐PCBs in humans

Published on: Tue, 20 Nov 2018 To enable the hazard identification and characterisation in the risk assessment for humans related to the seventeen 2,3,7,8‐substituted dioxins (PCCDs) and furans (PCDFs) and the twelve dioxin‐like polychlorinated biphenyls (DL‐PCBs), EFSA outsourced an extensive literature search (ELS), followed by selection for relevance and extraction of relevant data for consideration in the risk assessment. Two tailored search strategies for Web of Science (WoS) and PubMed for identif...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Roche Diagnostics to Replace CoaguChek® XS PT Test Strips

Roche Diagnostics to Replace CoaguChek® XS PT Test Strips

Roche Diagnostics will be proactively replacing all CoaguChek XS PT Test Strips in the United States.

FDA - U.S. Food and Drug Administration

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Recall of Green Cedar Dairy Ackawi Cheese Bearing a Sell by Date of March 26, 2019 or Later

Recall of Green Cedar Dairy Ackawi Cheese Bearing a Sell by Date of March 26, 2019 or Later

Routine samples of the Green Cedar Ackawi cheese collected and tested by the U.S. Food and Drug Administration and the Michigan Department of Agriculture and Rural Development tested positive for the presence of Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

16-11-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

Statement by FDA Commissioner Scott Gottlieb, M.D., on efforts to reduce animal testing through a study aimed at eliminating the use of dogs in certain trials

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to reduce use of animals through a study aimed at eliminating the use of dogs in certain trials

FDA - U.S. Food and Drug Administration

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA - U.S. Food and Drug Administration

9-11-2018

Medical Devices Safety Update, Volume 6, Number 6, November 2018

Medical Devices Safety Update, Volume 6, Number 6, November 2018

Standards minimise risk of misconnections; eltrombopag interference with test results; amniotic fluid tests

Therapeutic Goods Administration - Australia

1-11-2018

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

FDA warns patients and doctors about risk of inaccurate results from home-use device to monitor blood thinner warfarin

Roche Diagnostics issued voluntary recall of certain test strips used with CoaguChek meter devices; patients affected by the recall should seek alternative methods for testing.

FDA - U.S. Food and Drug Administration

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA - U.S. Food and Drug Administration

30-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Urgent: Curry Spice Recall

Urgent: Curry Spice Recall

This voluntary recall has been initiated by UBC Food Distributors Inc, due to a high level of lead found in the product after testing was done by the Michigan Department of Agriculture & Rural Development, which found high traces of lead.

FDA - U.S. Food and Drug Administration

24-10-2018

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

FDA - U.S. Food and Drug Administration

23-10-2018

Shimano North America recalls Lazer Bicycle Helmets

Shimano North America recalls Lazer Bicycle Helmets

The recalled helmets do not meet the CPSC standard for the "Dynamic Roll Off" test. The helmet may come off on impact posing a head injury to the user.

Health Canada

18-10-2018

CTG recalls Friction Powered School Bus

CTG recalls Friction Powered School Bus

Health Canada's sampling and evaluation program has determined that the school bus toy does not meet Canadian safety requirements for toys. Specifically, the school bus released small parts during testing, which are a choking hazard for young children.

Health Canada

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

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

11-10-2018

FDA approves new DNA-based test to determine blood compatibility

FDA approves new DNA-based test to determine blood compatibility

FDA approves new DNA-based test to determine blood compatibility.Test is first of this type approved to report genotypes as final results

FDA - U.S. Food and Drug Administration

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA - U.S. Food and Drug Administration

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination

HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia. Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled...

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

Living Well Remedies, LLC Issues Voluntary Nationwide Recall of Weight Away Remedy, Lot # 111417LWL614, Due To Microbial Contamination

Franklin Lakes, NJ, Living Well Remedies, LLC is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing.

FDA - U.S. Food and Drug Administration

15-1-2019

Ongoing stability testing for listed and complementary medicines

Ongoing stability testing for listed and complementary medicines

Updated to be consistent with PE009-13, the PIC/S Guide to GMP

Therapeutic Goods Administration - Australia

5-12-2018

Updates to the Database of TGA laboratory testing results

Updates to the Database of TGA laboratory testing results

New release of results published

Therapeutic Goods Administration - Australia

4-12-2018


Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products – report on actions taken

Europe - EMA - European Medicines Agency

26-11-2018

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

A stereotactic system used by neurosurgeons to more precisely determine where to perform their surgical procedure was intended to be MRI compatible but the older predicate it compared itself to was not, requiring additional performance testing.

FDA - U.S. Food and Drug Administration

26-11-2018

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understa

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understa

In 510(k), manufacturers often rely on comparative testing vs predicate devices to show a new device is as safe and effective as the predicate. But older predicates might not closely reflect the modern tech embedded in new devices or more current understanding of benefits & risks

FDA - U.S. Food and Drug Administration

6-11-2018

November is #DiabetesAwarenessMonth  #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes

November is #DiabetesAwarenessMonth #DYK using a glucose meter to check and monitor blood sugar is a daily part of life for millions of Americans with diabetes? Check out the @US_FDA's tips on how to safely use glucose meters and test strips for diabetes: https://go.usa.gov/xPdK4 

FDA - U.S. Food and Drug Administration

2-11-2018

.@US_FDA  issues a class I recall: Roche Diagnostics recalls CoaguChek  XS PT Test  Strips due to inaccurate INR test results. Find out more:  https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

.@US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevicepic.twitter.com/EYmVZHrUZc

. @US_FDA issues a class I recall: Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results. Find out more: https://go.usa.gov/xPVER  #FDA #MedicalDevice pic.twitter.com/EYmVZHrUZc

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

11-9-2018

 Focus group meeting  on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

Focus group meeting on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics harmonisation, European Medicines Agency, London, UK, From: 12-Oct-2018, To: 12-Oct-2018

This meeting will allow a direct exchange of views between the Agency’s working party and stakeholders on its draft reflection paper on dose optimisation of established veterinary antibiotics in the context of summary of product characteristics (SPC) harmonisation (EMA/CVMP/849775/2017). It complements the public consultation on this reflection paper ending on 31 January 2019. The reflection paper follows considerations in the report on a pilot project that aimed to develop and test non-experimental appr...

Europe - EMA - European Medicines Agency