KLERCIDE LOW RESIDUE QUAT

Primær information

  • Handelsnavn:
  • KLERCIDE LOW RESIDUE QUAT
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Medicinsk udstyr

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Lokation

  • Fås i:
  • KLERCIDE LOW RESIDUE QUAT
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Ecolab
  • Autorisationsnummer:
  • 116158E
  • Sidste ændring:
  • 12-03-2018

Produktresumé

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1907/2006

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PUNKT 1. IDENTIFIKATION AF STOFFET/ BLANDINGEN OG AF SELSKABET/ VIRKSOMHEDEN

1.1 Produktidentifikator

Produktnavn

Klercide Low Residue Quat

Produkt kode

116158E

Anvendelse af stoffet/det

kemiske produkt

Overfladedesinfektion

Stoftype

Blanding

Kun til erhvervsmæssig brug.

Information om fortyndning

Ingen information om fortyndning angivet.

1.2 Relevante identificerede anvendelser for stoffet eller blandingen samt anvendelser, der

frarådes

Identificerede anvendelser

Overfladedesinfektionsmiddel. Manuel proces

Overfladedesinfektionsmiddel. Spray og aftør, manuel proces

Anbefalede begrænsninger i

brugen

Forbeholdt industriel og erhvervsmæssig brug.

1.3 Nærmere oplysninger om leverandøren af sikkerhedsdatabladet

Firma

Ecolab ApS

Høffdingsvej 36

2500 Valby, Danmark Tel +45 36 15 85 85

dk-customerservice@ecolab.com

1.4 Nødtelefon

Nødtelefon

+4578746855

+32-(0)3-575-5555 Transeuropæisk

Giftinformationen tlf. nr.

82 12 12 12

Udstedelse-/revisionsdato

15.09.2017

Udgave

PUNKT 2. FAREIDENTIFIKATION

2.1 Klassificering af stoffet eller blandingen

Klassificering (FORORDNING (EF) Nr. 1272/2008)

Ikke et farligt stof eller blanding.

2.2 Mærkningselementer

Etikettering (FORORDNING (EF) Nr. 1272/2008)

Ikke et farligt stof eller blanding.

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2.3 Andre farer

Ingen kendte.

PUNKT 3. SAMMENSÆTNING AF/ OPLYSNING OM INDHOLDSSTOFFER

3.2 Blandinger

Bemærkninger

Ingen farlige indholdsstoffer

PUNKT 4. FØRSTEHJÆLPSFORANSTALTNINGER

4.1 Beskrivelse af førstehjælpsforanstaltninger

I tilfælde af øjenkontakt

Skyl med rigeligt vand.

I tilfælde af hudkontakt

Skyl med rigeligt vand.

Ved indtagelse.

Skyl munden. Søg læge hvis symptomer opstår.

Hvis det indåndes

Søg læge hvis symptomer opstår.

4.2 Vigtigste symptomer og virkninger, både akutte og forsinkede

I afsnit 11 findes mere detaljerede oplysninger om helbredspåvirkninger og symptomer.

4.3 Angivelse af om øjeblikkelig lægehjælp og særlig behandling er nødvendig

Behandling

Ingen specifikke foranstaltninger identificeret.

PUNKT 5. BRANDBEKÆMPELSE

5.1 Slukningsmidler

Egnede slukningsmidler

Brandslukningsforanstaltningerne skal være hensigtsmæssige i

forhold til lokale omstændigheder og det omgivne miljø.

Uegnede slukningsmidler

Ingen kendte.

5.2 Særlige farer i forbindelse med stoffet eller blandingen

Specifikke farer ved

brandbekæmpelse

Ikke brandfarligt eller brændbart.

Farlige

forbrændingsprodukter

Nedbrydningsprodukter kan omfatte de følgende materialer:

Carbonoxider

Nitrogenoxider (NOx)

Svovloxider

Fosforholdige oxider

5.3 Anvisninger for brandmandskab

Særlige personlige

værnemidler, der skal bæres

: Brug personligt beskyttelsesudstyr.

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af brandmandskabet

Yderligere oplysninger

: Brandrester og forurenet brandslukningsvand skal bortskaffes i

henhold til de lokale regler.

PUNKT 6. FORHOLDSREGLER OVER FOR UDSLIP VED UHELD

6.1 Personlige sikkerhedsforanstaltninger, personlige værnemidler og nødprocedurer

Rådgivning for ikke-

indsatspersonel

Der henvises til beskyttelsesforanstaltninger nævnt i afsnit 7 og 8.

Rådgivning for

indsatspersonel

Hvis særlig beklædning er påkrævet for at håndtere spildet, skal

man være opmærksom på alle oplysninger i punkt 8 om passende

og upassende materialer.

6.2 Miljøbeskyttelsesforanstaltninger

Miljøbeskyttelsesforanstaltnin

Ingen specielle miljømæssige forholdsregler kræves.

6.3 Metoder og udstyr til inddæmning og oprensning

Metoder til oprydning

Stands lækagen, hvis dette er sikkert. Opbevar og opsaml spild

med ikke brændbart absorberende materiale, (f. eks. sand, jord,

moler el. vermikulit) og placer det i affaldsbeholdere i henhold til

de lokale myndigheders forskrifter (se afsnit 13).Skyl rester væk

med vand. Ved store spild, inddæm det spildte materiale eller

saml det op på anden vis, for at sikre at spild ikke når vandveje.

6.4 Henvisning til andre punkter

Se Afsnit 1 for kontaktoplysninger i nødsituationer.

For personlig beskyttelse se punkt 8.

Se Afsnit 13 for yderligere oplysninger om affaldshåndtering.

PUNKT 7. HÅNDTERING OG OPBEVARING

7.1 Forholdsregler for sikker håndtering

Råd om sikker håndtering

Vask hænder efter håndtering. For personlig beskyttelse se punkt

Hygiejniske foranstaltninger

Vask hænder før pauser og straks efter håndtering af produktet.

7.2 Betingelser for sikker opbevaring, herunder eventuel uforenelighed

Krav til lager og beholdere

Opbevares utilgængeligt for børn. Hold beholderen tæt lukket.

Opbevares i behørigt mærkede beholdere.

Opbevaringstemperatur

0 °C til 25 °C

7.3 Særlige anvendelser

Særlige anvendelser

Overfladedesinfektionsmiddel. Manuel proces

Overfladedesinfektionsmiddel. Spray og aftør, manuel proces

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PUNKT 8. EKSPONERINGSKONTROL/PERSONLIGE VÆRNEMIDLER

8.1 Kontrolparametre

Indeholder ingen stoffer med grænseværdi for erhvervsmæssig eksponering.

8.2 Eksponeringskontrol

Passende tekniske foranstaltninger

Tekniske foranstaltninger

God generel ventilation skulle være tilstrækkeligt til at kontrollere

arbejdernes udsættelse for luftbårne urenheder.

Individuelle beskyttelsesforanstaltninger

Hygiejniske foranstaltninger

Vask hænder før pauser og straks efter håndtering af produktet.

Beskyttelse af øjne / ansigt

(EN 166)

Intet specielt beskyttelsesudstyr nødvendigt.

Beskyttelse af hænder (EN

374)

Intet specielt beskyttelsesudstyr nødvendigt.

Beskyttelse af hud og krop

(EN 14605)

Intet specielt beskyttelsesudstyr nødvendigt.

Åndedrætsværn (EN 143,

14387)

Ingen påkrævet, hvis luftbårne koncentrationer holdes under de

oplyste grænseværdier for eksponering. Brug certificerede

åndedrætsværn der opfylder EU-krav (89/656 / EØF, 89/686 /

EØF) eller tilsvarende, når respiratoriske risici ikke kan undgås

eller i tilstrækkelig grad begrænses ved kollektive tekniske

beskyttelsesforanstaltninger eller ved foranstaltninger, metoder

eller procedurer i tilrettelæggelse af arbejdet.

Foranstaltninger til begrænsning af eksponering af miljøet

Generelle anvisninger

: Overvej om det er nødvendig at lukke opbevaringsbeholderne

inde.

PUNKT 9. FYSISKE OG KEMISKE EGENSKABER

9.1 Oplysninger om grundlæggende fysiske og kemiske egenskaber

Udseende

: væske

Farve

: lysegul

Lugt

: svag

pH-værdi

5.5 - 7.5, 100 %

Flammepunkt

Ikke anvendelig

Lugttærskel

Ikke anvendelig og/eller ikke bestemt for blandingen

Smeltepunkt/frysepunkt

Ikke anvendelig og/eller ikke bestemt for blandingen

Begyndelseskogepunkt og

kogepunktsinterval

Ikke anvendelig og/eller ikke bestemt for blandingen

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Fordampningshastighed

Ikke anvendelig og/eller ikke bestemt for blandingen

Antændelighed (fast stof,

luftart)

Ikke anvendelig og/eller ikke bestemt for blandingen

Højeste eksplosionsgrænse

Ikke anvendelig og/eller ikke bestemt for blandingen

Laveste eksplosionsgrænse

Ikke anvendelig og/eller ikke bestemt for blandingen

Damptryk

Ikke anvendelig og/eller ikke bestemt for blandingen

Relativ dampvægtfylde

Ikke anvendelig og/eller ikke bestemt for blandingen

Relativ massefylde

0.995 - 1.005

Vandopløselighed

opløselig

Opløselighed i andre

opløsningsmidler

Ikke anvendelig og/eller ikke bestemt for blandingen

Fordelingskoefficient: n-

oktanol/vand

Ikke anvendelig og/eller ikke bestemt for blandingen

Selvantændelsestemperatur

Ikke anvendelig og/eller ikke bestemt for blandingen

Termisk spaltning

Ikke anvendelig og/eller ikke bestemt for blandingen

Viskositet, kinematisk

Ikke anvendelig og/eller ikke bestemt for blandingen

Eksplosive egenskaber

Ikke anvendelig og/eller ikke bestemt for blandingen

Oxiderende egenskaber

Stoffet eller blandingen er ikke klassificeret som oxiderende.

9.2 Andre oplysninger

Ikke anvendelig og/eller ikke bestemt for blandingen

PUNKT 10. STABILITET OG REAKTIVITET

10.1 Reaktivitet

Ingen farlige reaktioner kendt ved normalt brug under normale forhold.

10.2 Kemisk stabilitet

Stabil under normale forhold.

10.3 Risiko for farlige reaktioner

Ingen farlige reaktioner kendt ved normalt brug under normale forhold.

10.4 Forhold, der skal undgås

Ingen kendte.

10.5 Materialer, der skal undgås

Ingen kendte.

10.6 Farlige nedbrydningsprodukter

Nedbrydningsprodukter kan omfatte de følgende materialer:

Carbonoxider

Nitrogenoxider (NOx)

Svovloxider

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Fosforholdige oxider

PUNKT 11. TOKSIKOLOGISKE OPLYSNINGER

11.1 Oplysninger om toksikologiske virkninger

Oplysninger om sandsynlige

eksponeringsveje

Indånding, Øjenkontakt, Hudkontakt

Produkt

Akut oral toksicitet

: Der er ingen tilgængelige data på dette produkt.

Akut toksicitet ved indånding

: Der er ingen tilgængelige data på dette produkt.

Akut dermal toksicitet

: Der er ingen tilgængelige data på dette produkt.

Hudætsning/-irritation

: Der er ingen tilgængelige data på dette produkt.

Alvorlig

øjenskade/øjenirritation

: Der er ingen tilgængelige data på dette produkt.

Respiratorisk sensibilisering

eller hudsensibilisering

: Der er ingen tilgængelige data på dette produkt.

Kræftfremkaldende

egenskaber

: Der er ingen tilgængelige data på dette produkt.

Reproduktionsskadende

virkninger

: Der er ingen tilgængelige data på dette produkt.

Kimcellemutagenicitet

: Der er ingen tilgængelige data på dette produkt.

Fosterbeskadigelse

: Der er ingen tilgængelige data på dette produkt.

Enkel STOT-eksponering

: Der er ingen tilgængelige data på dette produkt.

Gentagne STOT-

eksponeringer

: Der er ingen tilgængelige data på dette produkt.

Aspiration giftighed

: Der er ingen tilgængelige data på dette produkt.

Potentielle sundhedspåvirkninger

Øjne

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Indtagelse

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Indånding

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Langtidspåvirkning

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Erfaringer med human eksponering

Øjenkontakt

Ingen kendte eller forventede symptomer.

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Hudkontakt

Ingen kendte eller forventede symptomer.

Indtagelse

Ingen kendte eller forventede symptomer.

Indånding

Ingen kendte eller forventede symptomer.

PUNKT 12. MILJØOPLYSNINGER

12.1 Økotoksicitet

Miljøpåvirkninger

Dette produkt har ingen kendt økotoksikologisk effekt.

Produkt

Toksicitet overfor fisk

: Ingen data tilgængelige

Toksicitet for dafnier og

andre hvirvelløse vanddyr.

: Ingen data tilgængelige

Toksicitet overfor alger

: Ingen data tilgængelige

12.2 Persistens og nedbrydelighed

Produkt

Ingen data tilgængelige

12.3 Bioakkumuleringspotentiale

Ingen data tilgængelige

12.4 Mobilitet i jord

Ingen data tilgængelige

12.5 Resultater af PBT- og vPvB-vurdering

Produkt

Vurdering

Dette stof/blanding indeholder ingen komponenter, der anses for

at være enten persistente, bioakkumulerende og toksiske (PBT)

eller meget persistente og meget bioakkumulerende (vPvB) ved

niveauer på 0.1% eller højere.

12.6 Andre negative virkninger

Ingen data tilgængelige

PUNKT 13. BORTSKAFFELSE

Bortskaffes i overensstemmelse med EU-direktiverne om affald og farligt affald.Affaldskoder skal

fastsættes af bruger, at fortrække i samarbejde med de myndigheder der er ansvarlig for

bortskaffelse af affald.

13.1 Metoder til affaldsbehandling

Produkt

: Fortyndet produkt kan skylles til sanitære kloaksystem

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Forurenet emballage

: Bortskaffes i overensstemmelse med lokale, regionale og

nationale bestemmelser.

Vejledning til valg af

affaldskoder

: Uorganisk affald der ikke indeholder farlige stoffer i en

koncentration >=0.1%. Hvis dette produkt anvendes i yderligere

processer, skal den endelige bruger omdefinere og tildele den

mest hensigtsmæssige Europæiske Affaldskatalogkode (EAK).

Det påhviler den der producerer affaldet at bestemme toksicitet og

fysiske egenskaber af materialet som genereres for at identificere

affaldet korrekt og bestemme bortskaffelsemetoder af affaldet i

overensstemmelse med gældende europæisk (EU direktiv

2008/98 / EF) og lokale bestemmelser.

PUNKT 14. TRANSPORTOPLYSNINGER

Afsenderen har ansvar for, at emballager, etikettering og mærkning er i overensstemmelse med den

valgte transportform.

Vejtransport (ADR/ADN/RID)

14.1 FN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

Lufttransport (IATA)

14.1 FN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

Søtransport (IMDG/IMO)

14.1 FN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

Ikke farligt gods

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forsigtighedsregler for

brugeren

14.7 Bulktransport i henhold

til bilag II til MARPOL 73/78

og IBC-koden

Ikke farligt gods

PUNKT 15. OPLYSNINGER OM REGULERING

15.1 Særlige bestemmelser/særlig lovgivning for stoffet eller blandingen med hensyn til

sikkerhed, sundhed og miljø

National lovgivning

Vær opmærksom på Dir 94/33/EF til beskyttelse af unge mennesker på arbejde.

15.2 Kemikaliesikkerhedsvurdering

Produktet indeholder stoffer, for hvilke der fortsat kræves en kemisk sikkerhedsvurdering.

PUNKT 16. ANDRE OPLYSNINGER

Procedure anvendt til at bestemme klassificeringen i henhold til

FORORDNING (EF) Nr. 1272/2008

Klassifikation

Begrundelse

Ikke et farligt stof eller blanding.

Beregningsmetoden

Fuld tekst af andre forkortelser

ADN - Europæisk konvention om international transport af farligt gods ad indre vandveje; ADR -

Europæisk konvention om international transport af farligt gods ad vej; AICS

- Australiens

fortegnelse over kemiske stoffer; ASTM - Det amerikanske forbund for testning af materialer,

ASTM; bw - Kropsvægt; CLP - CLP-forordningen om klassificering, mærkning og emballering;

Forordning (EF) Nr. 1272/2008; CMR - Kræftfremkaldende, mutagent eller reproduktionstoksisk

stof; DIN - Standard fra det tyske standardiseringsinstitut; DSL - Liste over indenlandske stoffer

(Canada);

ECHA

europæiske

kemikalieagentur;

EC-Number

EU-nummer;

Koncentration forbundet med x % respons; ELx - Belastningsgrad forbundet med x % respons;

EmS - Nødplan; ENCS - Eksisterende og nye kemiske stoffer (Japan); ErCx - Koncentration

forbundet med x % vækstrate respons; GHS - Det globale harmoniserede system; GLP - God

laboratoriepraksis;

IARC

Internationale

Agentur

Kræftforskning;

IATA

Internationale Luftfartssammenslutning, IATA; IBC - Den internationale kode for konstruktion og

udrustning af skibe, som fører farlige kemikalier i bulk; IC50 - Halv maksimal inhiberende

koncentration; ICAO - Organisationen for International Civil Luftfart, ICAO; IECSC - Fortegnelse

over eksisterende kemikalier i Kina; IMDG - Det internationale regelsæt for søtransport af farligt

gods; IMO - Den Internationale Søfartsorganisation; ISHL - Lov om industriel sikkerhed og

sundhed (Japan); ISO - International standardiseringsorganisation; KECI - Koreas fortegnelse

over eksisterende kemikalier; LC50 - Dødelig koncentration for 50 % af en testpopulation; LD50 -

Dødelig dosis for 50 % af en testpopulation (gennemsnitlig dødelig dosis); MARPOL - Den

internationale konvention om forebyggelse af forurening fra skibe; n.o.s. - Andet ikke angivet;

NO(A)EC - Koncentration for ingen observeret (negativ) virkning; NO(A)EL - Niveau for ingen

observeret (negativ) virkning; NOELR - Belastningsgrad for ingen observeret virkning; NZIoC -

New Zealands fortegnelse over kemikalier; OECD - Organisationen for Økonomisk Samarbejde

og Udvikling; OPPTS - Afdelingen for kemisk sikkerhed og forebyggelse af forurening; PBT -

Persistent, bioakkumulativt og giftigt stof; PICCS - Fillippinernes fortegnelse over kemikalier og

kemiske stoffer; (Q)SAR - (Kvantitativt) forhold mellem struktur og aktivitet; REACH - Europa-

parlamentets og Rådets forordning (EF) nr. 1272/2008 om registrering, vurdering og godkendelse

af samt begrænsninger for kemikalier; RID - Reglement for international befordring af farligt gods

med jernbane; SADT - Selvaccelererende dekompositionstemperatur; SDS - Sikkerhedsdatablad;

TCSI - Taiwans fortegnelse over kemiske stoffer; TRGS - Teknisk forskrift for farlige stoffer; TSCA

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- Lov om kontrol af giftige stoffer (USA); UN - Forenede Nationer; vPvB - Meget persistent og

meget bioakkumulativ

Udarbejdet af

Regulatory Affairs

Tal angives i sikkerhedsdatabladet i følgende form: 1,000,000 = 1 million og 1,000 = 1 tusind. 0.1

= 1 tiendedel og 0.001 = 1 tusindedel.

REVIDERET INFORMATION: Signifikante ændringer i den regulatoriske eller sundhedsmæssige

information af denne revision er angivet med en lodret streg i sikkerhedsdatabladets venstre

margin.

Informationerne i dette Arbejdshygiejniske Datablad er efter vor bedste viden, oplysninger og

overbevisning korrekte på datoen, hvor det er trykt. Informationerne tjener kun som vejledning til

sikker håndtering, brug, forarbejdning, lagring, transport, disponering og frigivelse og kan ikke

betragtes som en garanti eller kvalitetsangivelse. Informationerne vedrører kun det udtrykkeligt

angivne materiale og er ikke gældende for dette materiale anvendt i kombination med andre

materialer eller forarbejdning, medmindre udtrykkeligt anført i teksten.

BILAG: EKSPONERINGSSCENARIER

DPD+-stoffer

:

Følgende stoffer er de vigtigste stoffer der bidrager til blandingens eksponeringsscenarie i henhold

til DPD+-regelen:

Måde for

optagelse

Stof

CAS-Nr.

EINECS-Nr.

Ikke afhængighedsstof, ikke forlig

For at beregne om anvendelsesforholdene og de nødvendige risikohåndteringsforanstaltninger

er sikre, venligst kalkuler risikofaktor på dette web site:

www.ecetoc.org/tra

Eksponeringsscenariets korte

titel

Overfladedesinfektionsmiddel. Manuel proces

Use descriptors

Hovedbrugergrupper

Faglige anvendelser: Det offentlige område (administration,

uddannelse, forlystelser, tjeneste-ydelser, håndværkere)

Slutanvendelsessektor

SU22: Faglige anvendelser: Det offentlige område (administration,

uddannelse, forlystelser, tjeneste-ydelser, håndværkere)

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11 / 11

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titel

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20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

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

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

12-10-2018

Health Canada reminds Canadians of the risks of decorative contact lenses

Health Canada reminds Canadians of the risks of decorative contact lenses

OTTAWA – As Halloween approaches and many people consider their costumes, Health Canada is reminding consumers that decorative contact lenses pose health risks. It’s important to use these lenses safely.

Health Canada

10-10-2018

BSN SPORTS recalls Rubber Critter Toys

BSN SPORTS recalls Rubber Critter Toys

The paint on the toys contained levels of lead in excess of the allowable limit. Lead is toxic to children even at low exposure levels. Children can ingest harmful amounts of lead when they chew or suck items containing lead.

Health Canada

10-10-2018

Spiraledge Inc. recalls Backless Yoga Chair

Spiraledge Inc. recalls Backless Yoga Chair

The chairs may have missing screws or washers, loose screws or inadequate spot welding, resulting in potential collapse of the chair and injury to the user.

Health Canada

9-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

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

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

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

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

Published on: Wed, 03 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of ethopro...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Garderie Dépôt recalls Dream on Me Portable Cribs

Garderie Dépôt recalls Dream on Me Portable Cribs

The distance between the top surface of the lowest fixed side and the top surface of the mattress support is lower than what is required by law, posing a fall hazard.

Health Canada

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

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

28-9-2018

Debate on research dissemination at the Danish Medicines Agency

Debate on research dissemination at the Danish Medicines Agency

On 1 October, the Danish Medicines Agency and the Danish Society for Pharmacoepidemiology have invited a number of researchers, doctors and communication officers from research institutions throughout Denmark to a debate on how the findings of new health research can be disseminated most responsibly. The debate meeting can be followed live on the Danish Medicines Agency’s Facebook profile.

Danish Medicines Agency

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

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

26-9-2018

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Technical Report on the notification of syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country pursuant to Article 14 of Regulation (EU) 2015/2283

Published on: Tue, 25 Sep 2018 00:00:00 +0200 Abstract Following a notification from Sorghum Zrt., submitted to the European Commission under Article 14 of Regulation (EU) 2015/2283 to place on the market syrup from Sorghum bicolor (L.) Moench as a traditional food from a third country (TF), and in line with Article 15(2) of that Regulation, EFSA was asked by the European Commission whether there are duly reasoned safety objections to the placing on the market of the TF within the European Union. The ap...

Europe - EFSA - European Food Safety Authority Publications

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

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

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

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

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

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

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

Danish Medicines Agency

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

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

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

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

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

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

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

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

11-9-2018

 Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

Risk assessment guideline focus group meeting, European Medicines Agency, London, UK, From: 19-Sep-2018, To: 19-Sep-2018

The Antimicrobials Working Party of the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP) is holding a focus group meeting with stakeholders to discuss the revision of the antimicrobial veterinary medicinal product risk assessment guideline, following a public consultation on the draft revised guideline ending on 31 October 2018. The meeting will focus on topics identified during this public consultation. This guideline aims to provide guidance to marketing authorisat...

Europe - EMA - European Medicines Agency

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

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

5-9-2018

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical devices

FDA - U.S. Food and Drug Administration

5-9-2018

 Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin, adopted

Opinion of the CVMP on the establishment of maximum residue limits: Porcine prolactin, adopted

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Europe - EMA - European Medicines Agency

5-9-2018

 Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the CVMP on the establishment of maximum residue limits: Eprinomectin, adopted

Opinion of the Committee for Medicinal Products for Veterinary Use on the establishment of maximum residue limits

Europe - EMA - European Medicines Agency